Vice President, Head of Pharmacovigilance

Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. 

Alumis is seeking an experienced Vice President, Head of Pharmacovigilance, to lead the development of and support the operational aspects of the company’s pharmacovigilance initiatives. You will have experience in overall PV operations strategy and will apply it across the portfolio including case management, aggregate safety reporting, safety database strategy, vendor oversight, compliance, inspection readiness, budget, contracts and training.  This position will report to the Chief Medical Officer.

Position responsibilities:

• Hands-on oversight of vendor deliverables and measurements associated with safety & PV for both planned and active clinical programs
• Partner with clinical development representatives to lead safety signal assessments and validate safety signals
• Lead Drug Safety Committees as a primary member alongside the Chief Medical Officer
• Develop Core Safety Information
• Contribute written summaries and assessments for safety components of protocols, statistical analysis plans, clinical study reports, etc. by working directly with team members and offering tactical support when needed
• Oversee/Review safety sections of periodic aggregate reports
• Heading the safety strategy for regulatory communication and providing oversight of higher-level documents to support submission activities.
• Ensure compliance with global safety requirements and inspection readiness by digging into root-cause analyses and offering solutions when needed
• Manage relationships with clients and team members providing expert safety knowledge
• Provide safety review of clinical study documents including protocols, study reports, regulatory submission components
• Demonstrate ability to engage and collaborate with team members across diverse teams while prioritizing and achieving commitments
• Build the Alumis safety and PV organization aligned with the expanding clinical and commercial portfolio

Qualifications

• MD, PhD or PharmD accompanied by relevant safety & PV experience in biotechnology or pharmaceutical industry, plus 15+ years of industry experience
• 5+ years' experience in building teams, directly or matrix and leading projects

• Training and experience as a clinician in the Immunology area preferred
• Experience in risk management strategies and signal detection strategies

• Robust knowledge of global PV requirements
• Experience overseeing safety/PV vendors
• Experience with regulatory authority inspections
• Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs
• Proven track record in providing safety strategies at the highest level and evaluate appropriate tactics as this new function needs

• Strong business acumen and ability to collaborate with cross-functional partners to achieve enterprise goals
• Effective written, verbal communication and interpersonal, relationship-building skills
• Effective negotiation skills that lead to being able to influence without authority
• Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize workload on multiple ongoing projects
• Ability to work across diverse teams in a matrix organizational structure, both in leading and as part of a cross-functional team
• Organized, attention to detail, and able to meet timelines in a fast-paced environment
• Able to work with a high level of autonomy and independence

This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.

Alumis Inc. is an equal opportunity employer.

Alumis Inc. is an equal opportunity employer. If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated.