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Job Opportunities

Cytokinetics’ openings, when available, are listed below. If you see an opportunity that appeals to your area of expertise, please click on the associated link to learn more about that position.

Accounting & Finance

Department: Accounting and Finance

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

The Manager, Finance and Controller of G&A is responsible for the preparation of departmental budgets and forecasts for G&A departments and the preparation of G&A monthly accruals and variance reporting.

 

Responsibilities:

  • Work closely with G&A department heads to budget, forecast, track and manage spend against each departmental budget while ensuring that the information is processed and incorporated in the Company’s actual financials, budgets and forecasts
  • Responsible for ensuring purchase requisitions are issued in accordance with the contracts, work orders and change orders and ensuring they are appropriately funded within the Board approved budget or forecast
  • Manage invoices for approval by ensuring charges are in accordance with the terms for the respective agreements
  • Responsible for timely preparation of G&A department monthly accruals in accordance with the accounting policies and procedures, including leading monthly accrual meetings with department heads
  • Coordinate G&A budget and actual reporting on a worldwide, consolidated basis
  • Provide training on finance concepts to G&A department heads as necessary
  • Assist with vendor confirmations to verify account balances and project status
  • Provide monthly variance analysis to department managers
  • Perform ad hoc analyses as requested by management

 

Qualifications

  • Bachelor’s degree in Accounting, Finance or Business
  • 8+ years accounting and financial planning experience working in a Sarbanes-Oxley control environment
  • Strong knowledge and understanding of GAAP accounting and financial principals
  • Excellent problem solving and interpersonal skills
  • Experience with project tracking and accounting
  • Excellent oral and written communication skills
  • Experience with Great Plains Dynamics, a plus
  • Highly organized and self-directed approach to work, including the ability to handle multiple projects with competing deadlines
  • Advanced Excel skills
  • Life Science company experience required
  • Public company experience required

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Department: Account and Finance

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

Primary Responsibilities:

The Senior Director, Finance and Controller is responsible for directing worldwide functional accounting, including budget and forecasting, accounting close and reporting, as well as design and implementation of internal controls, coordination of the audit and audit-related activities and tax compliance and reporting.

The Senior Director, Finance and Controller establishes and maintains financial policies and procedures related to business processes, risk management and internal controls and effectively communicates these policies and procedures throughout the organization, ensuring a close collaboration with internal functional groups to match business needs and efficiencies with appropriate financial controls.

As lead liaison for auditors for annual audit, quarterly reviews and Sarbanes-Oxley reporting, the Senior Director, Finance and Controller ensures effective coordination with Accounting, SEC reporting, Corporate Finance/FP&A and Treasury to deliver high quality and timely information to the financial reporting process.

As Cytokinetics expands for commercial activity outside the United States, the Senior Director, Finance and Controller will manage on a worldwide basis to ensure the coordination of all controllership activities. The Senior Director, Finance and Controller reports directly to the Senior Vice President, Chief Accounting Officer.

 

Responsibilities:

  • Directs the worldwide functional budget and forecasting and related accounting close and reporting
  • Ensures the quality and timeliness of information for SEC and other reporting
  • Coordinates and assures functional budget and functional forecasts
  • Establish and maintain financial policies and procedures
  • Leads Sarbanes-Oxley compliance
  • Lead liaison with external audit firms, including diligence and comfort processes.
  • Manages tax returns and tax provision with external tax advisors
  • Reviews, researches, determines and documents the accounting implications of major transactions, including coordination with functional area leads and legal to review and approve major corporate contracts
  • Working with IT and other functional areas, serves as key leader in ensuring financial and enterprise resource planning systems are designed and implemented to support worldwide integrated biopharmaceutical operations
  • Provides accounting and business expertise to corporate development transactions, including collaboration agreements
  • Assesses the financial implications of new accounting pronouncements
  • Supports cross-functional functional and project teams
  • Manages treasury activities
  • Oversees Purchasing

 

Qualifications:

  • Expertise in the areas of controllership, corporate accounting, controls, SEC and tax – significant prior public company experience is a must
  • BS/MBA in accounting and CPA
  • 12+ years of related experience and demonstrated leadership in Finance
  • Knowledge and understanding of the biotechnology industry, including experience in functional and project-based budgeting and forecasting in a late-stage or commercial enterprise
  • Excellent written and verbal communication skills
  • Demonstrated success in staff development
  • Experience with enterprise resource system design and implementation
  • A strong desire to collaborate on a cross-functional basis to ensure achievement of our corporate goals and objectives

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Analytical Chemistry

Department: Analytical Chemistry

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

We are looking for a postdoctoral research scientist in our DMPK/Analytical Chemistry Department.

 

Responsibilities

  • The successful candidate will be involved in evaluating in vitro and in vivo studies to characterize absorption, distribution, metabolism and excretion properties of new drug candidates to support drug discovery and development programs
  • The candidate will have the opportunity to participate in project team meetings and interaction with colleagues of other disciplines with our research community
  • In addition, the candidate will involve in research activities to establish software, technologies and concepts in areas including but not limited to PK/PD simulation and modeling and up to date LC/MS/MS methodologies in Cytokinetics

 

Qualifications

  • PhD in biochemistry or related disciplines with an interest in a career within pharmaceutical R&D
  • Knowledge in fields of pharmacokinetics, drug metabolism, bioanalysis, LC/MS/MS, PK/PD simulation and modeling
  • Toxicology experience highly desirable
  • Excellent written and verbal communication and presentation skills
  • Strong interpersonal and leadership skills
  • Ability to work within a multidisciplinary team

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Business Development

Department: Business Development

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

Responsibilities:

In conjunction with and reporting to the Sr. Vice President of Business Development, the Senior Manager/Associate Director, Business Development and Alliance Management will focus on building value through strategic alliances and/or licensing transactions.

The responsibilities for this position involve serving as a cross-functional leader working in close coordination with key senior staff and consultants (e.g., within Commercial Development, Intellectual Property and Legal Affairs, Finance, Project Management and R&D) and engaging with our partners and potential partners at all levels.

 

This individual will:

  • Serve as a key contact for existing partners and on the team responsible for identifying, evaluating, negotiating, and executing new strategic alliances and/or licensing transactions
  • Participate in Cytokinetics’ strategic planning process
  • Develop and maintain strong internal and external relationships to facilitate effective execution of business development campaigns, including due diligence, terms development and negotiation
  • Ensure effective partnership governance and planning
  • Provide guidance to others working on Cytokinetics’ partnerships and lead initiatives to enhance business development and alliance management capabilities

 

Qualifications:

  •  A minimum of 7 years of post-baccalaureate experience in the biotechnology/pharmaceutical industry is required. Based on years of relevant experience, candidates at the Manager level may be considered
  • Advanced degree (e.g., M.B.A., J.D., Ph.D., etc.) with a relevant technical degree
  • Track record of productive participation in a business development or alliance management role
  • Experience with negotiating and/or managing contractual relationships, including firm understanding of IP/licensing fundamentals
  • Excellent analytical capabilities, strong interpersonal and communication skills, demonstrated creativity, flexibility and problem-solving ability, solid knowledge base regarding business development and alliance management practices and trends, and proven ability to work effectively in a team environment with interactions across multiple, diverse disciplines

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Clinical Biometrics

Department: Clinical Biometrics

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

We are currently seeking a Director of Clinical Data Management in our Biometrics department

 

Responsibilities:                                                                                                            

  • Provides leadership, mentorship to internal data management staff
  • Provides leadership and direction for outsourced activities
  • Oversees all assigned clinical trials to ensure data quality, integrity and timeliness
  • Works closely with the Study Management Team to set study goals and objectives
  • Responsible for managing, leading and overseeing DM operational activities by ensuring compliance with the corporate timelines and scope of work
  • Accountable for hands-on management of trials and resources while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards
  • Supervise, manage, and lead the design, implementation and ongoing practices of clinical DM processes with internal resources and/or vendors.
  • Lead vendor and technology evaluation, qualification and selection
  • Manage reconciliations between clinical and safety databases
  • Budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting
  • Responsible for managing and tracking work orders associated with clinical DM activities to ensure that the operating costs for the DM department are achieved within budget
  • Creates and maintains positive, cohesive work environment
  • Responsible for the global standardization of DM processes and process improvement and efficiency

 

Qualifications:

  • Bachelors Degree in related field, or an equivalent combination of education and work experience
  • 10 years’ experience in Clinical Data Management at a CRO, biotechnology, or pharmaceutical company; and minimum of 4 years’ prior management experience
  • Must have expert knowledge of good data management practices in global clinical trials
  • Thorough knowledge of applicable regulatory rules and guidelines
  • Complex and/or international trials experience
  • Demonstrated proficiency in the data management processes
  • Possesses excellent interpersonal communication skills (written and verbal)
  • Strong attention to detail
  • CDSIC expertise
  • Proficient in the use of the clinical data management systems (e.g. Medidata Rave)
  • Possesses a positive attitude and works well with others

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Clinical Operations

Department: Clinical Operations

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

Responsibilities:

The Clinical Trials Manager will work under the supervision and guidance of the Manager/Senior Manager, Clinical Operations to provide key clinical support for the operation and execution of clinical trials for Cytokinetics clinical programs. The individual will ensure completion of the following clinical drug development activities:

 

  • Requires minimal supervision to manage various activities associated with multiple clinical studies in accordance with designated project assignments
  • Working knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct
  • Has had experience as clinical operations co-lead/lead on a significant Phase II or Phase III program
  • Independently designs or assists in the development of study related documents including but not limited to: case report forms, case report form completion guidelines, study manuals and project tools, monitoring plans, tracking tools, informed consent forms
  • Contributes as part of the clinical protocol development team
  • Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed
  • Leads study management team meetings and teleconferences with study vendors
  • Manages study-specific CROs and vendors, as appropriate
  • Performs monitoring or co-monitoring of sites as required by needs of project
  • May prepare study-specific training materials or slides for Investigator Meetings. May attend scientific meetings as a representative of Cytokinetics clinical operations team
  • Adds insight regarding evaluation and selection of CRO’s, contractors and other outside vendors
  • Manages efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff and other Cytokinetics departments as appropriate
  • Works with Clinical Finance Staff on vendor and study site budget tracking and compliance
  • Uses well-developed problem-solving skills to address needs of program and provides guidance to other lower level personnel
  • Ability to collaborate with other departments within CR&D to meet study timelines and goals

 

Qualifications: 

  • BA/BS in science-related field with 3-8+ years’ work experience as a CRA or CRA/CTM combination of relevant related work experience
  • Excellent written and verbal communication skills required
  • Demonstrated thorough understanding of FDA regulations and GCP
  • Well-developed strong problem solving skills
  • Exceptional interpersonal skills with demonstrated successful team participation
  • Demonstrated skill in managing multiple tasks simultaneously, with attention to detail
  • Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc
  • Ability to travel important as the position could require approximately 25% time spent in business travel

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Clinical Research

Department: Clinical Research

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

We are currently seeking a key physician to join our team and provide clinical oversight to clinical trials to our development programs in neuromuscular diseases. The position will report to the Clinical Director of Neuromuscular Therapeutics. This role will be chartered to provide medical guidance to all aspects of product development including clinical advisory board management, protocol design, clinical trial site recruitment/implementation and monitoring; as well as data interpretation and reporting.  He/she will also support and play a pivotal role in supporting large Phase II & III studies in ALS and/or SMA. The position is also expected to support future IND, Phase I-III and NDA submissions.

 

Responsibilities:

  • Serves as a source of medical expertise for clinical project teams
  • Provides input to decisions that have medical, scientific, and future marketing implications
  • Provides medical input into the design, planning, initiation and completion of clinical trials
  • Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions
  • Serves as the medical monitor for the successful conduct, integrity, and safety of patients in our clinical trials
  • Establishes communications and relationships with prominent clinical investigators in the areas of skeletal muscle function
  • Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events
  • Applies the strategic intent of the Company when working with regulatory bodies such as FDA, and with key opinion leaders
  • Performs product safety medical reviews for assigned investigational drugs
  • Ensures an appropriate level of customer service to internal and external customers

 

Qualifications:

  •  MD, MD/PhD, or DO degree with neurology board certification by the American Board of Neurology and Psychiatry with either significant clinical investigator experience or a minimum of 1 year in clinical development experience in a biotechnology or pharmaceutical company. Sub-specialty training and prior industry experience in the clinical development of neuromuscular therapeutics is required; experience with studies in ALS is a strong plus
  • Knowledge of CDER regulations/ICH guidelines
  • Understanding of pharmaceutical safety reporting and surveillance requirements
  • Excellent verbal and written communication skills and presentation skills
  • Strong interpersonal skills
  • Leadership skills
  • Desire to work within a multidisciplinary team
  • Computer literacy
  • Ability to work internationally

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

  

Submit your resume online now.

Department: Clinical Research

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

We now offer a unique opportunity to an academic clinical neurologist to join our team as a Clinical Research Fellow in Neuromuscular Diseases.  During a negotiable 1-2 year commitment based at Cytokinetics’ offices in South San Francisco, the Fellow will contribute invaluable expertise to our clinical development programs in neuromuscular diseases.  The Fellow will benefit from an experience rarely available in a strictly academic position; i.e., the day-to-day leadership and management of a clinical trial aimed at the development of new therapeutics for patients.  The Fellow may engage in this opportunity in the context of their academic fellowship as a means to satisfy a research requirement if agreeable to their institution.  Continued involvement in the clinical management of patients during the period of this fellowship will be encouraged.  The Fellow may return to his or her academic post at the conclusion of the term, enriched by this experience in addition to returning to the parent institution with a portfolio of valuable clinical research competencies.

 

The Fellow will report to the Clinical Director of Neuromuscular Therapeutics at Cytokinetics. Compensation will be at industry-competitive standards commensurate with experience and a benefit package can be provided.  In participating in clinical trials, the Fellow will also participate in our collaboration with Astellas as a member of the  Project Team, clinical advisory board management; protocol design; clinical trial site recruitment, initiation, and monitoring; and data interpretation and reporting.

 

Responsibilities:

  • Serve as a primary source of neuromuscular expertise for the study management team, clinical project team, and other internal and external stakeholders as required
  • Provide input to decisions that have medical, scientific, and future marketing implications for Cytokinetics’ investigational new drugs that may eventually treat a broad array of neuromuscular diseases
  • Contribute to the design, planning, initiation and completion of clinical trials in neuromuscular diseases
  • Liaise with scientists within and outside of Cytokinetics to inform our basic and translational research on skeletal muscle activators
  • Author the medical components of key documents, including study protocols and related regulatory submissions
  • Manage communications and relationships with other prominent clinical investigators and thought leaders in neuromuscular diseases
  • Represent Cytokinetics at scientific and patient-focused meetings related to neuromuscular diseases
  • Help to implement Cytokinetics’ clinical development strategies during interactions with regulatory authorities such as FDA and EMA
  • Monitor and interpret the accumulating clinical safety data for Cytokinetics’ investigational new drugs

 

Qualifications:

  • MD, MD/PhD, or DO degree with neurology board certification or eligibility by the American Board of Psychiatry and Neurology
  • Experience in the management of patients with SMA is desired; experience with clinical trials of therapeutics intended for the treatment of SMA or other neuromuscular diseases and expertise in muscle physiology and nerve cell function would be a critical advantage
  • Excellent written and verbal communication and presentation skills
  • Strong interpersonal and leadership skills
  • Ability to work within a multidisciplinary team

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

  

Submit your resume online now.

Department: Clinical Research

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

Reporting to the EVP Research & Development, the Director, Clinical Pharmacology will be responsible principally for early clinical drug development activities with a strong focus on Phase I and Phase IIa clinical trials. He/She will work closely with the Clinical Research Group and other members of the R&D team to ensure a strategic view is taken for the pipeline progression of individual projects.

Responsibilities:  

  • Design Phase I and Phase IIa clinical studies, including dose escalation, stopping rules and risk-benefit to ascertain that compounds are entered into man safely, efficiently and with scientific validity
  • Responsible for the medical content of clinical pharmacology studies
  • Responsible for the medical aspects of clinical pharmacology components related to regulatory documents and interact with regulatory authorities for all phases of drug development
  • Medical monitor in sponsored studies as appropriate, ensure that the clinical teams correctly handle all adverse events (AEs) and serious adverse events (SAEs) in accordance with ICH standards
  • Correctly apply the ICH and GCP regulations surrounding the primary activities of clinical development projects
  • Operate within the time and budget constraints of the clinical program
  • In collaboration with the Chief Medical Officer, train members of the product development team to enhance their skills
  • Communicate project-related information, including the planning and execution of meetings and presentations
  • Coordinate and complete scientific documents including protocols, clinical study reports, other regulatory documents
  • Travel up to 30% as necessary according to project needs

 

Qualifications:

  • MD, MD/PhD, or PharmD (Registered Medical Doctor preferred)
  • PhD in clinical pharmacology would be an asset
  • Board certification/specialist registration in clinical pharmacology highly desirable or significant prior relevant experience
  • At least 5 years of experience in drug development in the pharmaceutical and/or biotech industry, covering both early and translational phase development or significant participation in industry sponsored research as a clinical investigator
  • Randomized controlled clinical trial principles, methodology and procedures
  • Adverse medical event investigation, analysis, as well as reporting procedures and standards
  • FDA and EMA regulatory requirements and ICH/GCP guidelines is an asset
  • Federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects
  • Statistical data collection, editing, validation and analysis techniques
  • Current and developing trends and standards in clinical trials monitoring
  • Industrial standards as applied to GCP and GLP
  • Infrastructure and operational characteristics of Contract Research Organizations (CROs) and centralized clinical laboratories
  • Ability to develop and implement clinical research monitoring plans and study specific procedures
  • Ability to establish data collection and management guidelines
  • Ability to communicate, interact and present competently and professionally both verbally and in writing at all levels within a broad, complex clinical research environment including third parties such as CRO’s and academia

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Corporate Development

Department: Corporate Development

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

The Director, New Product Planning, Cardiovascular will lead franchise and commercial strategy development for the company’s emerging cardiovascular business.  He/she will be responsible for setting the strategic direction for the company’s corporate development, business development and portfolio planning with the objective to build the cardiovascular franchise into a sustainable business.  This individual will work cross-functionally and with partners to ensure that our cardiovascular programs in Research and development are positioned well to address high unmet clinical needs, aligned with long range planning objectives and are readied for commercial success.  In addition, this individual will work cross-functionally to support in-licensing, M&A and certain medical affairs activities.  This role will report into the Vice-President, New Product Planning and Commercial Development.

 

Responsibilities:

  • Establish the strategic commercial direction, in collaboration with development colleagues, for the cardiovascular franchise and ensure its alignment with corporate long-term goals
  • Provide input to the forecasting team based on medical best practices, newly emerging practices, and existing or pending competitive products in development in cardiovascular indications
  • Develop global strategic plan for new product planning activities associated with CV portfolio, specifically omecamtiv mecarbil
  • Coordinate development of commercialization plan for omecamtiv mecarbil with Amgen, including annual tactical activities and budget
  • Develop and maintain strong relationships with key opinion leaders, customers including representatives of local/regional healthcare system, payers and industry associations to uncover opportunities which enhance product line performance and maximize product line earnings
  • Coordinate with market research lead to oversee and ensure implementation of market research and analytics, in accordance with the plan
  • Serve on project and commercial operating teams and provide senior leadership with responsibility to project status, timelines and decision criteria
  • Research, evaluate and recommend potential growth strategies through expansion into new therapeutic categories, markets and related businesses
  • Lead the development of a commercialization plan for late stage clinical asset in heart failure and collaborate with finance team on the corporate long-range plan
  • Collaborate with business partner on issue specific long-range strategic implications (for example, manufacturing strategy, pre-clinical target assessments, portfolio planning, etc.)
  • Develop market and opportunity assessments, including disease area understanding, competitive landscapes and unmet need
  • Collaborate with program management, medical affairs and the clinical team on the development therapeutic product profiles
  • Lead the development of the revenue forecasts for clinical compounds in collaboration with key business partners (Finance, Program Management, etc.)
  • A strong connection to the vision of the organization which is focused on bringing innovative and effective therapies to patients confronting devastating diseases of impaired muscle function
  • Participate as a member of the governance activities for collaborations

 

Qualifications:

  • Minimum of 8 years of related Marketing/ New Product Planning experience in the biotech/pharmaceutical industry
  • Experience in Business Development and/or within Commercial teams desired
  • Extensive Cardiovascular therapeutic experience required; Heart Failure experience preferred
  • A minimum of a Bachelor’s degree in a related area. M.B.A. is a preferred
  • Demonstrated experience navigating complex market scenarios, rapidly changing payer/patient environments and market access barriers
  • Leadership in the development and implementation of launch and marketing plans
  • In-depth knowledge and understanding of the drug discovery and drug development processes. This includes a working knowledge of pharmaceutical product development (pre-clinical through phase III), IND/NDA development, manufacturing/packaging, distribution and forecast analytics
  • A demonstrated in-depth knowledge of regulatory/compliance policies is required
  • Must demonstrate the ability to work in a highly collaborative manner with commercial and medical teams
  • Self-motivated, energetic individual who is comfortable working diverse set of projects
  • Possess a genuine interest in helping to improve the lives of patients and their families who are afflicted with these disorders
  • Strong understanding of business strategy, marketing planning tools and processes
  • Exceptional project management skills with ability to manage multiple projects in a cross-functional environment with good understanding of project management process
  • Strong customer focus with the ability to adapt to internal client needs and expectations
  • Strong ability to influence outcomes without direct authority and ability to hold oneself and others accountable for commitments
  • Highly organized and detail oriented with excellent follow-up abilities
  • Strong knowledge of key pharmaceutical functions throughout all stages of product development, including Marketing (e.g., Market Research, Market Access), Medical Affairs, Preclinical, Clinical, Regulatory, CMC (e.g. supply chain, drug delivery), etc

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

  

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Pharmacology

Department: Pharmacology

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

We are looking for a postdoctoral research scientist in our Pharmacology Department with an interest in a career in pharmaceutical R&D.

 

Responsibilities

  • The successful candidate will be involved in in vivo, in situ and ex vivo studies to characterize the pharmacodynamic effects of new drug candidates on skeletal and/or cardiac muscle function to support our drug discovery and development programs
  • The candidate will also be involved in research activities to establish biomarkers that may predict functional outcomes in non-clinical disease models
  • In addition, the candidate will have the opportunity to participate in project team meetings and to interact with colleagues of other disciplines within our research community

 

Qualifications:

  • PhD in physiology, pharmacology or a related discipline
  • Knowledge in fields of skeletal or cardiac muscle physiology, pharmacology, genetics and proteomics
  • Neuromuscular physiology experience is highly desirable
  • Experience in small and large molecule analysis by LC/MS/MS methodologies is a plus
  • Excellent written and verbal communication and presentation skills
  • Strong interpersonal and leadership skills
  • Ability to work within a multidisciplinary team

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

Submit your resume online now.

Department: Pharmacology

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

We are looking for a postdoctoral research scientist in our Pharmacology Department.

 

Responsibilities

  • Help design, conduct and manage experimental studies related to the discovery of novel drug candidates in the areas of cardiovascular and skeletal muscle diseases
  • Create, establish and validate in vivo and in vitro models to conduct efficacy and mechanism of action studies
  • Manage and analyze experimental data and present experimental results at internal project team meetings
  • Develop protocols and maintain detailed documentation of procedures

Qualifications:

  • PhD in Muscle Biology, Pharmacology, Physiology, or a related discipline
  • Extensive knowledge in cardiovascular and/or skeletal muscle biology
  • Experience in establishing and executing cardiovascular and skeletal muscle disease models
  • Experience with data management and presentation, experimental design, and data analysis methods
  • Supervisory experience would be an advantage
  • Ability to work independently and in a team lab environment
  • Excellent communication skills and ability to work in multidisciplinary project teams

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

Submit your resume online now.

Project Management

Department: Project Management

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

This position will have both cross functional project management responsibilities for a global Phase 3 clinical trial, and will have primary project management responsibility for our cardiovascular partnership.  They will be responsible for assisting functional leaders in defining, tracking, and communicating progress to internal management and partnership Governance bodies.

 

Responsibilities

  • Ensure progress of projects according to the approved Joint Development Plan and/or Joint Commercial Plan, timeline and budget.
  • Facilitate and lead effective project team meetings, including the creation of effective meeting agendas and clear documentation of key issues for discussion, decisions made and assigned action items
  • Represent Cytokinetics project management with Project Management counterparts within CRO(s) and guide the programs efficiency through Phase 3 clinical trial
  • Partner with Alliance Management to develop agendas for and to facilitate Governance meetings
  • Effectively utilize Project Management tools, ensuring standardization across departments, functions, collaborators and CROs
  • Guide the team to overcome cross-functional hurdles; ensure timely identification and escalation/resolution of issues to facilitate achievement of the programs objectives
  • Provide additional project manager support for IND enabling studies for second compound in cardiovascular pipeline

 

Qualifications

  • Bachelor’s Degree or equivalent required (scientific or healthcare discipline preferred), MBA or advanced degree a plus
  • PMI certification is a plus but not required
  • 7+ years’ experience in project management with strong pharmaceutical drug discovery and development experience including IND and Phase I/II experience
  • Experience with the development, deployment and maintenance of project management tools and customized project templates (Access, MS Project, SharePoint)
  • Experience with planning and oversight of project budgets
  • Experience writing, reviewing and editing drug study or regulatory documents
  • Computer Skills: SharePoint, Word, Excel, Project, PowerPoint
  • Demonstrated success in a matrix management environment
  • Must have strong analytical and interpersonal communication skills

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Quality Assurance

Department: Quality Assurance

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

The Associate Director/Director, Clinical Quality Assurance (CQA) will be responsible for providing GCP and compliance related advice to internal clinical study teams and as well as maintaining CQA confidential files and SOPs. This position will coordinate clinical study related audits (e.g., Clinical Sites, Clinical Vendors, and internal clinical functional areas and systems) for compliance with Good Clinical Practices (GCP), study protocols and instructional documents, regulations and other applicable standards. He/She will ensure appropriate GCP-related and Inspection Awareness training is made available for internal staff. This position is also expected to assist clinical sites conducting Cytokinetics’ studies to successfully host regulatory inspections and also assist in hosting or supporting GCP and Drug Safety/Pharmacovigilance (DS/PV) regulatory inspections at Cytokinetics.

 

Responsibilities

Oversight of Clinical QA daily operations for GCP compliance, oversight of contract auditors, and the quality of all deliverables including:

  • Oversee and perform day-to-day CQA activities
  • Assign CQA attendees to Study Management Team (SMT) meetings; Attend SMT meetings and provide compliance-related advice as needed
  • Ensure Audit Plans are created for Cytokinetics-sponsored clinical trials in compliance with internal SOPs; Approve audit plans when assigned this activity
  • Ensure that audits are conducted in compliance with Audit Plans and internal SOPs
  • Assign qualified GCP internal and contract auditors to perform GCP-related audits; ensure documentation of qualifications for each GCP auditor including CV of education and experience and training on associated SOPs is filed in CQA files
  • Co-audit with assigned auditors as needed to evaluate quality of audit activities an compliance with internal SOPs. Perform and report GCP-related audits when necessary
  • Review GCP-related audit reports in a timely manner for consistency in description of findings and classification of seriousness (Critical, Major, Minor) in compliance with CQA SOPs. Provide feedback to the assigned auditors and approve audit reports before finalization
  • Ensure audit findings are discussed with internal stake holders and provide compliance perspective regarding classification of findings
  • Provide audit findings to Clinical Vendors and internal stake holders per CQA SOPs and track resolutions to completion
  • Maintain CQA confidential audit files, schedules, and audit plans
  • Trend audit findings; create Audit Trends reports
  • Perform biennial review of CQA SOPs and create new CQA or revise existing CQA SOPs as needed. Approve CQA SOPs in the absence of the Sr. Director, CQA
  • Review and approve new and revised SOPs describing the responsibilities and activities of GCP functional areas
  • Provide formal compliance opinions providing interpretation of SOPs, regulations, and regulatory authority guidance
  • Collaborate with other QA colleagues to ensure GCP training and Inspection Awareness/Readiness training are performed at Cytokinetics at least annually and track participation
  • Work across departments to set priorities for GCP-related audits and Inspection Awareness/Readiness
  • Act as back-up inspection host or back-room support as assigned for any GCP-related or DS/PV inspection performed at Cytokinetics
  • Create/approve plans and site training for use during clinical site inspection training. Assist clinical sites to respond to regulatory inspections associated with Cytokinetics-sponsored clinical trials
  • Assist in creating Cytokinetics’ responses to GCP-related or DS/PV inspections at Cytokinetics
  • Remain current in regulatory requirements and industry standards for GCP
  • Perform annual personnel reviews of internal auditors

 

Qualifications:

  • BS/MS/Ph.D. in science, nursing, or other education with strong experience; minimum of 6 to 10 years’ experience working in FDA-regulated clinical research including at least 3 to 5 years Clinical QA
  • Keen understanding of the key requirements for compliance of clinical research and Drug Safety as described in Regulatory Authority (e.g., FDA and European) regulations and guidance, including ICH
  • The technical ability to critically analyze and synthesize compliance-related information and present the associated risks
  • Ability to coordinate internal and contract auditors and communications to audited entities (e.g., clinical investigators, clinical vendors, and internal staff).
  • Experience auditing Phase I-III clinical trials
  • Experience in hosting or supporting GCP-related or Drug Safety/Pharmacovigilance-related regulatory inspections
  • Excellent writing and editing skills
  • Ability to work independently, manage multiple priorities, and execute on goals
  • Excellent interpersonal communication skills

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Regulatory & Compliance

Department: Regulatory & Compliance

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

Reporting into the Senior Vice President of Regulatory and Compliance, the Director/Senior Director, Regulatory Affairs will be responsible for leading activities of Regulatory Affairs with an emphasis on global regulatory strategy and the preparation, review and submission of documents to the FDA and other regulatory authorities. This position will be key in collaborations with Cytokinetics’ partners for the development of new molecules for Orphan and other diseases as well as the strategic coordination of multiple indications for these new molecules.

 

Responsibilities:

  •  Formulates regulatory strategies based on current regulatory intelligence
  • Oversees implementation of regulatory strategy and activities needed to secure approval of new drugs
  • Oversees coordination, preparation and timely submission of regulatory documents
  • Maintains current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required)
  • Provides regulatory advice to other functional areas
  • Serves as a principal interface with reviewers from FDA and other health authorities
  • Identifies gaps in product development plans that may pose regulatory issues
  • Participates in regulatory due diligence activities

Relationships:

  • Maintains and builds collaborative relationships with partners to improve effectiveness in regulatory
  • Develops and maintains cooperative relationships with external vendors and regulatory health authorities
  • Coordinates activities for meetings with FDA, EMEA, and other regulatory authorities
  • Mentors department personnel and updates appropriate departments on the current regulatory environment

Management:

  • Supervises employees, consultants/contractors in Regulatory Affairs
  • Optimizes employee performance by developing employees and promoting career growth
  • Develops and implements regulatory operating guidelines and common work practices/strategies within the team

 

Qualifications:

  • Advanced degree MD, Pharm.D. or Ph.D. preferred
  • 10+ years of drug development and regulatory affairs experience in the Biotech/Pharmaceutical industry
  • Experience in Orphan Drug development and approvals
  • Demonstrated ability to interpret and stay current with FDA, EMA and other regulatory agency regulations and guidelines
  • Experience with eCTD requirements and electronic submissions
  • Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory
  • Demonstrated knowledge of regulatory aspects of small molecule Chemistry, Manufacturing and Controls and quality assurance is a plus
  • Extensive experience in drug development and approval processes (INDs, NDAs, MAAs) across all phases of development
  • Experience with labeling requirements is a plus
  • Demonstrated management expertise, including leadership and development of employees
  • Ability to work effectively across teams, functions and with outside partners
  • Excellent oral and written communication skills
  • Excellent organizational skills and attention to detail

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com  

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.

Department: Regulatory & Compliance

Job Location: South San Francisco

As a leader in muscle biology research, we are dedicated to our mission of improving the lives of people confronting devastating diseases of impaired muscle function. We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving the lives of people with debilitating diseases in which muscle performance is compromised and/or declining. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.

 

The Senior/Principal Medical Writer will be responsible for collaborating with a number of departments in writing, reviewing and preparing a variety of technical documents, including: protocols/amendments, investigator brochures, consent forms, annual reports, DSURs, final study reports, and sections of INDs and NDAs. While the focus will be in the clinical and regulatory areas, the ability to assist with preparation of CMC documentation and drafts of scientific publications is a strong plus. The Senior Medical Writer will coordinate document preparation with a team of writers, as needed.

 

Responsibilities:

  • Draft high-quality clinical & regulatory documents that demonstrate a good grasp of the scientific and medical content and drug development process with excellent understanding of data analysis, data management and regulatory submissions
  • Work across departments to help set priorities for document preparation and collaborate on document content
  • Coordinate and manage consulting writers as needed
  • Work with service providers as needed for delivery of high quality documents
  • Write clinical abstracts, posters, and manuscripts
  • Review and edit documents prepared by other authors
  • Maintain document history and manage version control of documents
  • Provide guidance for style guides for document preparation
  • Keep current with relevant therapeutic area(s)

 

Qualifications:

  • BS/MS/Ph.D. with minimum of 8 years’ experience working as a Medical Writer in the biotech/pharmaceutical industry
  • The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents
  • Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, CTXs, NDAs and MAAs
  • Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
  • Ability to coordinate other writers in the preparation of complex submissions
  • Experience with Phase I-III clinical trials including international regulatory requirements
  • Proficiency with medical terminology and ability to articulate drug development data, process, and regulatory submissions
  • Expertise regarding Clinical Study Report (CSR) and appendices
  • Experience with event and drug coding dictionaries (MedDRA, Who Drug Dictionary)
  • Knowledge and experience with CMC sections of INDs, NDAs, and other submissions is a strong plus
  • Skilled with software applications and document management systems, including experience with document templates
  • Excellent editing skills
  • Ability to work independently, manage multiple priorities, and execute on goals
  • Excellent interpersonal communication skills

 

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

 

Please visit our website at: www.cytokinetics.com  

Cytokinetics is an Equal Opportunity Employer

 

Submit your resume online now.