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

    Arcus Biosciences
    9+ 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:

    The Senior Medical Director of Patient Safety & Pharmacovigilance will provide critical medical expertise and leadership across the expanding Arcus oncology clinical portfolio. This role involves overseeing core medical activities, including safety signal management, risk management, and benefit-risk strategies for our assets. The individual will collaborate effectively across all levels of the organization and with external Regulatory Authorities. Reporting to the Head of Safety, this leader will also manage Safety Physicians and Safety Scientists.

    Responsibilities:

    • Develop, oversee, and execute 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 clinical trial protocols, Investigator’s Brochures (IB), Company Core Data Sheets (CCDS), informed consent forms (ICF), and other study documents to ensure alignment with asset benefit-risk profiles.
    • Lead the creation of developmental risk management plans by engaging with cross-functional stakeholders.
    • Provide strategic medical input into safety assessments and requests for information from Regulatory Authorities.
    • Prepare and review sections of Regulatory Authority submission packets for Investigational New Drug (IND), New Drug Applications (NDAs), and Marketing Authorization Applications.
    • Participate in Drug Monitoring Committees (iDMC) as applicable.
    • Contribute to scientific publications for meetings and journals (abstracts, posters, papers).
    • Assist in the medical safety evaluation for new business development opportunities, including due diligence evaluations.
    • Recruit, hire, mentor, and manage direct reports, overseeing employee performance evaluations.

    Qualifications:

    • Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) degree required; experience in oncology within academic or hospital settings preferred.
    • 7+ years of relevant experience as a Safety Physician, with a preference for candidates who have worked on NDA and BLA submissions in oncology.
    • Proven ability to create, evaluate, and maintain effective business processes, implementing systems and tools to optimize resources within the Safety department.
    • Strong capacity to work effectively in a dynamic, complex, and fast-paced team environment.
    • Track record of strong personal performance and the ability to build and lead high-performing teams.
    • In-depth knowledge of global pharmacovigilance regulations and requirements (EMA, FDA, PMDA, Asia-PAC, ICH).
    • Solid project and people management experience, with the ability to coach and mentor team members.
    • Excellent interpersonal, communication, analytical, and organizational skills.

    Location:

    This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote.

    Compensation:

    The anticipated salary range for qualified candidates is $280,000 - $350,000 USD annually. This range is an estimate of expected compensation for this position and may vary based on factors such as education, experience, skills, internal equity, and market alignment. In addition to a competitive salary, Arcus offers stock program participation, performance-based bonuses, and a comprehensive benefits package. More information about our total rewards program can be found here.

    Equal Opportunity Employment:

    Arcus Biosciences is an Equal Opportunity Employer committed to fostering a workplace free from discrimination and harassment. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets.

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