Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
The Senior Director, Medical Safety & Pharmacovigilance serves as the safety expert and global lead for pharmacovigilance and risk management at Cytokinetics. This position is responsible for the global safety strategy and overall safety profile of investigational and marketed products. As Senior Director, Medical Safety & Pharmacovigilance, this person will be responsible for oversight of PV and Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs, signal detection, preparation of safety reports, and risk management activities, and will work collaboratively with project teams and outside partners.
Responsibilities
• Provide strategic and medical leadership for global safety surveillance and risk management activities across all investigational and, as applicable, marketed products, ensuring proactive benefit-risk assessment throughout the product lifecycle.
• Lead the development, implementation, and continuous improvement of pharmacovigilance policies, procedures, and safety governance processes that support regulatory compliance and operational excellence.
• Ensure compliance with global pharmacovigilance regulations and reporting requirements, including FDA, EMA, ICH, and other applicable health authority standards.
• Serve as the medical lead for signal detection and signal management activities, including identification, evaluation, interpretation, and communication of emerging safety signals through review of individual case reports, aggregate safety data, clinical trial data, literature, and external sources.
• Conduct and oversee medical review of serious adverse events, adverse events of special interest, and individual case safety reports to ensure accurate medical assessment and regulatory reporting.
• Chair and lead Safety Management Team (SMT) meetings and other safety governance forums, driving timely safety decision-making and escalation of significant safety issues.
• Author, review, and approve safety assessments, benefit-risk evaluations, signal evaluation reports, and safety recommendations for internal stakeholders, regulatory authorities, and external partners.
• Provide strategic leadership and oversight for the preparation and review of aggregate safety reports and regulatory safety submissions, including DSURs, PBRERs/PSURs, IND annual reports, expedited safety reports, integrated summaries of safety, and marketing application documents.
• Direct the development and maintenance of core safety documents, including Investigator Brochures, Reference Safety Information (RSI), Company Core Data Sheets (CCDS), Safety Management Plans, and Risk Management Plans, as applicable.
• Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and Clinical Operations to integrate safety perspectives into development strategy and regulatory interactions.
• Collaborate with alliance partners, licensors, CROs, and external vendors on pharmacovigilance operations, safety monitoring, signal management activities, and safety data exchange agreements.
• Represent Drug Safety and Pharmacovigilance in cross-functional governance committees, development teams, due diligence evaluations, and interactions with regulatory authorities.
• Build, develop, and mentor a high-performing team of pharmacovigilance physicians and safety professionals, fostering scientific excellence, accountability, and career growth.
• Ensure inspection readiness and maintain a state of compliance for all pharmacovigilance activities; actively support health authority inspections, partner audits, and internal quality assessments.
• Monitor and interpret emerging regulatory requirements, industry trends, and evolving best practices in pharmacovigilance, risk management, and signal detection, translating them into organizational strategies and processes.
• Review and evaluate relevant scientific and medical literature to support ongoing safety assessments and benefit-risk evaluations.
• Contribute to corporate development activities, including due diligence assessments, asset evaluations, and integration planning for business development opportunities, as needed.
Qualifications
• MD, MD PHD, or MD MPH required
• 12+ years pharmaceutical industry experience in pharmaceutical drug development, including significant experience in pharmacovigilance and drug safety leadership.
• Deep understanding of global pharmacovigilance regulations, including FDA, EMA, ICH, and other regional requirements.
• Demonstrated experience leading safety surveillance, signal detection, risk management, and aggregate reporting activities for investigational and/or marketed products.
• Strong scientific and clinical judgment with the ability to evaluate complex safety data and communicate benefit-risk assessments effectively.
• Proven leadership experience managing teams and influencing cross-functional stakeholders in a matrix environment.
• Excellent written and verbal communication skills with experience presenting to senior leadership, governance committees, regulators, and external partners.
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Pay Range:
The expected salary range for this position based on the primary location of South San Francisco, CA is $351,180-$409,710. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
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Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
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Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer