Senior Medical Director, Patient Safety & Pharmacovigilance (Office Or Remote)

7+ years

Not Disclosed

Remote, USA

10 Oct. 1, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position: Senior Medical Director, Patient Safety & Pharmacovigilance

Description:

Arcus Biosciences is seeking a Senior Medical Director to provide medical expertise and leadership across our expanding oncology clinical portfolio. This role involves supporting essential medical activities related to safety signal management, risk management, and benefit-risk strategies for our assets. The successful candidate will collaborate effectively across all organizational levels and with external regulatory authorities. Reporting to the Head of Safety, this leader will directly manage Safety Physicians and Safety Scientists.

Responsibilities:

Develop and oversee the execution of the signal detection strategy for the Arcus portfolio.
Prepare and review periodic aggregate reports, including IND Annual Reports, Development Safety Update Reports (DSUR), and Periodic Benefit Risk Evaluation Reports (PBRER).
Review and contribute to relevant sections of clinical trial protocols, Investigator’s Brochures (IB), Company Core Data Sheets (CCDS), informed consent forms (ICF), and other study-related documents to align with asset benefit-risk profiles.
Lead the creation of developmental risk management plans, engaging cross-functional stakeholders for input.
Provide strategic medical input for Regulatory Authority safety assessments and information requests.
Prepare and review relevant sections for Regulatory Authority filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications.
Participate in Drug Monitoring Committees (iDMC) as needed.
Contribute to scientific publications (abstracts, posters, papers) for conferences and journals.
Assist in the medical safety evaluation of new business development opportunities, including due diligence evaluations.
Recruit, mentor, and manage direct reports, overseeing performance evaluations.

Qualifications:

Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) degree required; academic or hospital oncology experience preferred.
7+ years of relevant experience as a Safety Physician, preferably with experience in oncology and NDA/BLA submissions.
Proven ability to create and maintain effective business processes and implement systems to optimize Safety department resources.
Experience working in dynamic, complex, and fast-paced environments.
Demonstrated success in building and leading high-performing teams.
Strong understanding of global pharmacovigilance requirements and regulations (EMA, FDA, PMDA, Asia-PAC, ICH).
Exceptional people and project management skills with a focus on coaching and mentoring.
Excellent interpersonal, communication, analytical, and organizational skills.

Location and Compensation:

This role can be based in Hayward or Brisbane, CA (preferred), or can be performed remotely. The anticipated salary range for fully qualified candidates is $280,000 - $350,000 USD annually. This range is an estimate based on various factors, including individual education, experience, and market alignment. In addition to a competitive salary, Arcus offers stock program participation, performance-based bonuses, and a comprehensive benefits package. For more details, please visit our careers page.

Equal Opportunity Employment:

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to equal employment opportunity for all employees and do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets.

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Senior Medical Director, Patient Safety & Pharmacovigilance (Office Or Remote)

Job Description

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