What are the responsibilities and job description for the Director, Pharmacovigilance position at Navigator Medicines, Inc.?
ABOUT NAVIGATOR MEDICINES
Navigator Medicines is a clinical-stage biopharmaceutical company pioneering bispecific antibody therapies anchored in OX40L inhibition. Our science targets the root drivers of complex inflammatory and autoimmune diseases — conditions that have long eluded effective treatment. We are a focused, exceptional team united by urgency and scientific rigor, working to bring new hope to patients living with these challenging diseases.
POSITION SUMMARY
The Director of Pharmacovigilance will serve as the leader of Navigator Medicines' PV function, responsible for building and managing all aspects of drug safety surveillance, case processing, and regulatory reporting / oversight of reporting if done by CRO, across our early-phase pipeline. This role is fundamentally about early-phase risk management — proactively identifying, characterizing, and mitigating safety signals in first-in-human and Phase 1/2 studies where the benefit-risk landscape is still being defined. As a small-team environment, this individual must exercise strong independent judgment about when to escalate safety concerns to the CMO, Clinical/Regulatory leadership, or regulatory authorities, and when to manage issues within established frameworks. The Director will shape the global PV strategy for our bispecific antibody programs and serve as a key partner to Clinical Development, Clinical Operations and Regulatory Affairs. This is a high-impact, highly visible role where individual contributions directly shape patient safety and program success.
Safety Surveillance & Case Management
Required
Navigator Medicines is an equal opportunity employer committed to diversity and inclusion in the workplace. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by applicable law.
Navigator Medicines is a clinical-stage biopharmaceutical company pioneering bispecific antibody therapies anchored in OX40L inhibition. Our science targets the root drivers of complex inflammatory and autoimmune diseases — conditions that have long eluded effective treatment. We are a focused, exceptional team united by urgency and scientific rigor, working to bring new hope to patients living with these challenging diseases.
POSITION SUMMARY
The Director of Pharmacovigilance will serve as the leader of Navigator Medicines' PV function, responsible for building and managing all aspects of drug safety surveillance, case processing, and regulatory reporting / oversight of reporting if done by CRO, across our early-phase pipeline. This role is fundamentally about early-phase risk management — proactively identifying, characterizing, and mitigating safety signals in first-in-human and Phase 1/2 studies where the benefit-risk landscape is still being defined. As a small-team environment, this individual must exercise strong independent judgment about when to escalate safety concerns to the CMO, Clinical/Regulatory leadership, or regulatory authorities, and when to manage issues within established frameworks. The Director will shape the global PV strategy for our bispecific antibody programs and serve as a key partner to Clinical Development, Clinical Operations and Regulatory Affairs. This is a high-impact, highly visible role where individual contributions directly shape patient safety and program success.
Safety Surveillance & Case Management
- Oversee receipt, triage, medical review, and submission / oversight of submission if done by CRO of individual case safety reports (ICSRs), including expedited reports (SAEs, SUSARs)
- Manage aggregate safety reporting including DSURs, IND annual reports, PSURs/PBRERs, and ad hoc safety analyses
- Lead early-phase safety risk management including signal detection, threshold-setting, benefit/risk analysis and real-time safety review in FIH and Phase 1/2 studies; define stopping rules, dose escalation safety criteria, and sentinel event frameworks in collaboration with Clinical Development
- Apply sound independent judgment to determine when emerging safety data warrants escalation to the CMO, Clinical/Regulatory leadership, regulatory authorities, or the — balancing urgency with thoroughness — and lead benefit-risk assessments and risk minimization strategy in partnership with clinical leadership
- Design, implement, and maintain Navigator Medicines' phase appropriate global pharmacovigilance system, including PV Master File (PSMF) and SOPs to integrate safety processes across the product lifecycle
- Establish PV governance structures, quality standards, and vendor oversight frameworks in alignment with ICH E2A–E2F guidelines
- Serve as the primary contact for PV-related audits and regulatory inspections; lead PV-related inspection readiness activities, ensuring compliance with global safety regulations
- Evaluate and select safety database platforms and third-party PV service providers as needed
- Author and review safety sections of clinical protocols, IBs, INDs, CTAs, BLAs/NDAs, and other applicable regulatory submissions
- Interface directly with FDA, EMA, and other health authorities on PV matters; respond to safety-related queries and commitments
- Collaborate with Clinical Operations on SAE reconciliation, safety data monitoring, and Data Safety Monitoring Board (DSMB) and/or safety review committee (SRC) support
- Partner with Regulatory Affairs on labeling reviews, RMP development, and REMS considerations
- Support due diligence activities for potential business development transactions from a PV perspective
- Partner with Clinical Development to develop and maintain up-to-date reference libraries supporting safety and regulatory documents (e.g., IB, DSUR), ensuring accuracy, traceability, and consistency of cited literature across submissions.
- Build and lead the PV function as the organization scales
- Collaborate with Quality on vendor qualification activities, manage CRO and safety vendor relationships, including contract negotiations, oversight plans, and quality metrics
- Provide PV training to internal stakeholders including clinical, regulatory, quality, and commercial teams
Required
- MD, PharmD, PhD, or equivalent advanced degree in a life science or health-related field
- 7-10 years of progressive pharmacovigilance experience in the pharmaceutical or biopharmaceutical industry
- Deep expertise in global PV regulations, including FDA 21 CFR Parts 312/314/600, EMA GVP modules, and ICH E2 guidelines
- Hands-on experience managing ICSRs, aggregate reports (DSURs, PSURs), and regulatory authority interactions (specific to safety)
- Experience establishing or significantly building a PV function in a small or mid-sized biotech
- Proven ability to exercise independent judgment in ambiguous, high-stakes safety situations — including knowing when to escalate to clinical leadership, regulatory authorities, or governance bodies — while operating effectively in a fast-moving, resource-constrained environment
- Experience in immunology, autoimmune disease, or biologic/bispecific antibody development
- Familiarity with OX40L pathway biology or related inflammatory disease mechanisms
- Experience with safety database systems (e.g., Veeva Vault Safety, Argus, ARISg)
- Prior involvement in BLA/MAA submissions or post-marketing PV programs
- Experience supporting SRC/DSMB/DMC activities and charter development
- The opportunity to help build a critical function from the ground up at a mission-driven clinical-stage company
- Close collaboration with a small, high-caliber leadership team that values scientific excellence and transparency
- Competitive base salary, equity participation, and comprehensive benefits
- A culture grounded in urgency, trust, and genuine commitment to patients with inflammatory and autoimmune diseases
Navigator Medicines is an equal opportunity employer committed to diversity and inclusion in the workplace. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by applicable law.