Director, Drug Safety Physician

7+ years

Not Disclosed

South San Francisco

10 April 18, 2025

Job Description

Job Type: Full Time Education: MD/PhD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director, Drug Safety Physician

Locations: South San Francisco, California
Time Type: Full Time
Posted On: Posted Today
Job Requisition ID: R148

About Cytokinetics:
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases where cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Job Purpose:
The Director, Drug Safety Physician is responsible for managing key pharmacovigilance activities, including the detection and analysis of safety issues for investigational drug products, in compliance with global pharmacovigilance and regulatory requirements. This role provides medical and strategic input for adverse event monitoring, coding, and signal detection to ensure that global PV regulatory standards are met. The Director will report to the Head of Drug Safety and Pharmacovigilance and collaborate across departments and with partner companies.

Responsibilities:

Perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and communication of safety assessments for investigational products.
Participate in developing and implementing safety surveillance strategies, policies, and procedures for all investigational products.
Conduct medical review of individual case safety reports.
Contribute to the creation of analysis of similar events.
Collaborate with partners on safety monitoring, signal detection, and risk management activities.
Participate in establishing and maintaining Safety Data Exchange Agreements.
Collaborate, contribute to, and review relevant sections of clinical and regulatory documents, including protocols, informed consent forms, study reports, integrated summaries of safety, expedited safety reports, DSURs, marketing applications, and other regulatory submission documents.
Contribute to the creation and maintenance of Reference Safety Information, Investigator Brochures, and company core data sheets.
Review and summarize scientific literature relevant to pharmacovigilance activities.
Participate in inspection readiness activities and preparation as needed.
Stay current with international pharmacovigilance requirements and guidelines, with a focus on FDA and EMA standards.

Qualifications:

MD or equivalent, PharmD, or advanced degree in nursing.
7+ years of drug safety experience, including at least 5+ years managing medical case review and signal detection.
Strong knowledge of international safety reporting and pharmacovigilance requirements.
Ability to take initiative while collaborating on multiple projects and working with partner companies to achieve compliance with PV and regulatory requirements.
Excellent written and oral communication skills.
Excellent interpersonal skills and ability to work effectively in team environments.
Experience in neurology and/or cardiovascular drug development is desirable.

Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $251,800 - $278,300 USD per year. Base pay will consider internal equity, geographic region, job-related knowledge, skills, and experience among other factors.

Commitment to Diversity and Inclusion:
Cytokinetics values diverse backgrounds and celebrates differences. We seek the best candidates for open roles, even if they do not meet every qualification. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we encourage you to apply.

Fraud Warning:
All legitimate offers from Cytokinetics will come directly from our official email domain (cytokinetics.com) after a formal interview process. We do not conduct interviews via non-standard text messaging applications, request personal banking information prior to official offer acceptance, or ask candidates to purchase equipment during hiring. Contact talentacquisition@cytokinetics.com if you have doubts about an offer.

Website: www.cytokinetics.com

Equal Opportunity Employer

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Director, Drug Safety Physician

Job Description

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