Medical Director, Safety and Pharmacovigilance

Title: Medical Director, Safety and Pharmacovigilance (Office OR Remote)

Location: Hayward United States

Job Description:

The Medical Director, Safety and Pharmacovigilance will provide medical expertise across the growing Arcus clinical portfolio by supporting a variety of core medical activities including the management of safety signal, risk management, and benefit-risk strategies for the assets as well as support medical reviewer on individual case safety reports (ICSRs). This individual must effectively collaborate cross-functionally at all levels of the organization as well as with external Regulatory Authorities. This leader will report into the Executive. Medical Director for Patient Safety and Pharmacovigilance.

Responsibilities:

• Develop, contribute to, and oversee the execution of the signal detection strategy for the Arcus portfolio.
• Coordinate cross-functional Safety Review Teams and Chairs Safety Management Committees.
• Preparation and review of periodic aggregate reports (IND Annual Reports, Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Report (PBRER), EU renewal, etc.)
• Review, contribute, and author as appropriate, relevant sections of the clinical trial protocols, the Investigator's Brochure (IB), Company Core Data Sheet (CCDS), informed consent form (ICF) and other study specific documents to ensure alignment with the asset benefit-risk profiles.
• Leads the effort to create developmental risk management plans by seeking input from cross-functional stakeholders.
• Provides strategic medical input into Regulatory Authority safety assessments and requests for information.
• Prepare and review relevant sections of the Regulatory Authority filing and submission documents for NDs, NDA/BLA/MAAs, etc.
• Participate in and provide input for internal monitoring committees, iDMCs/DSMBs, as applicable.
• Contribute to scientific publications (abstracts, posters, papers) for scientific meetings and/or journals.
• Contribute, as appropriate, to the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).

Qualifications:

• Education: Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) degree required. Academic or hospital setting oncology experience preferred.
• 3+ years' relevant Safety experience required. Experience working in oncology including NDA/BLA submission activities are preferred but not required.
• Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within the Safety department.
• Demonstrated ability to work effectively in a dynamic, complex, cross-functional, and fast-paced team environment.
• Excellent interpersonal, communication, analytical, and organizational skills.

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $280,000 - $320,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.

EOE

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

Physical Requirements Office Setting

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

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