ED/ VP Medical Safety Leader

Verto People; Somerville (MA); On-site; USD 350,000 - 520,000; Full time

Job summary

Verto People Ltd is seeking an Executive Director or VP of Medical Safety to lead global pharmacovigilance for immunology portfolios. You will drive safety strategy across preclinical to late-stage development, applying clinical and regulatory expertise in a fast-growing biotech setting.

You will shape safety governance, oversee external partners, and collaborate with Clinical, Regulatory and Translational Medicine teams, reporting to executive leadership.

Qualifications

• MD, MD-PhD or equivalent medical qualification – essential.
• 5–7+ years in medical safety, pharmacovigilance or clinical development.
• Proven leadership of clinical safety across early development.
• Strong understanding of immunology/inflammation.
• Experience with biologics, mAbs or oral therapeutics desirable.
• Expertise in AE assessment, signal detection and safety reporting.
• Knowledge of global PV regulations and FDA/EMA expectations.
• Experience overseeing CROs and external safety vendors.
• Ability to lead cross‑functional safety governance.
• Experience supporting IND/CTA submissions.

Responsibilities

• Define and lead global medical safety and pharmacovigilance strategies.
• Oversee safety activities from candidate selection through FIH and later stages.
• Lead benefit-risk assessments and risk mitigation across portfolios.
• Review SAEs, safety signals and immunogenicity risks.
• Oversee safety input into DSURs, PSURs/PBRERs and RMPs.
• Collaborate with Clinical Development, Regulatory Affairs and Operations.
• Review protocols, I.B.s and safety monitoring plans.
• Lead external pharmacovigilance vendors and ensure regulatory compliance.
• Represent safety in regulatory authority interactions.
• Establish safety governance frameworks and SOPs.
• Present safety assessments and development recommendations to leadership.

Skills

Medical safety leadership

Pharmacovigilance

IND/CTA submissions

Regulatory knowledge

Education

MD or MD-PhD or equivalent

Job description

Executive Director / VP, Medical Safety & Pharmacovigilance – Immunology

Location: East Coast, United States (Preferred)
Employment: Full-Time | Permanent
Level: Executive Director / Vice President
Therapeutic Area: Immunology / Inflammation / Immune-Mediated Diseases

Are you an experienced Medical Safety or Pharmacovigilance leader with a strong background in immunology, inflammation and clinical drug development? This is an exciting opportunity to join an innovative, rapidly growing biotechnology company leveraging AI-driven drug discovery and next-generation biologics to develop breakthrough therapies for patients with significant unmet medical needs.

We are seeking a strategic, hands-on Executive Director or VP of Medical Safety to lead global safety strategy across a growing portfolio of biologic and oral therapeutics, from preclinical development and First-in-Human (FIH) studies through Proof-of-Concept (PoC) and later-stage clinical development. The successful candidate will thrive in a fast-paced biotech environment, combining strong medical judgement with expertise in pharmacovigilance, benefit-risk assessment, safety surveillance and cross-functional leadership.

Key Responsibilities:

• Define and lead global medical safety and pharmacovigilance strategies across immunology, inflammation and immune-mediated disease programmes.

• Oversee safety activities from candidate selection and IND/CTA-enabling studies through FIH, early clinical development and later-stage programmes.

• Lead benefit-risk assessments, safety signal detection, evaluation and risk mitigation strategies across the development portfolio.

• Provide medical oversight of adverse events, serious adverse events, emerging safety signals and immunogenicity risks.

• Oversee medical input into aggregate safety reports, including DSURs, PSURs/PBRERs, Risk Management Plans (RMPs) and regulatory safety documentation.

• Collaborate with Clinical Development, Toxicology, Translational Medicine, Regulatory Affairs and Clinical Operations to ensure integrated safety strategies.

• Review clinical protocols, Investigator Brochures and safety monitoring plans, including dose escalation, stopping rules and patient eligibility criteria.

• Lead external pharmacovigilance vendors, ensuring regulatory compliance, high-quality case processing and timely safety reporting.

• Represent medical safety in interactions with regulatory authorities, including the FDA, EMA and other global health agencies.

• Establish and strengthen pharmacovigilance processes, safety governance frameworks, SOPs and safety data exchange agreements.

• Present safety assessments, emerging risks and development recommendations to executive leadership and governance committees.

Candidate Requirements:

• MD, MD-PhD or equivalent medical qualification – essential.

• 5–7+ years of pharmaceutical or biotechnology experience within medical safety, pharmacovigilance or clinical development.

• Proven experience leading clinical safety and pharmacovigilance activities across early-stage development – essential.

• Strong understanding of immunology, inflammation or immune-mediated diseases, including dermatology, rheumatology, gastroenterology or respiratory indications.

• Experience supporting the development of biologics, monoclonal antibodies, multispecific antibodies or oral therapeutics is highly desirable.

• Deep expertise in adverse event assessment, safety signal detection, benefit-risk evaluation and aggregate safety reporting.

• Strong knowledge of global pharmacovigilance regulations, ICH-GCP requirements and FDA/EMA regulatory expectations.

• Experience overseeing CROs, pharmacovigilance vendors and external safety service providers.

• Demonstrated ability to lead cross-functional safety governance and influence clinical development decisions.

• Experience supporting IND/CTA submissions, health authority interactions and clinical trial safety monitoring.

• Excellent medical judgement, strategic leadership, communication and stakeholder management skills.

• Comfortable working in a fast-paced, entrepreneurial biotechnology environment with evolving priorities.

What's on Offer?

• Executive Director or Vice President-level opportunity within an innovative, rapidly growing biotechnology company.

• Opportunity to shape and lead global medical safety and pharmacovigilance strategy across a developing immunology portfolio.

• Exposure to cutting-edge AI-enabled drug discovery, next-generation biologics and innovative therapeutic modalities.

• Significant influence over clinical development decisions, benefit-risk strategies and long-term portfolio progression.

• Opportunity to establish and expand medical safety and pharmacovigilance capabilities as the organisation grows.

• Collaboration with multidisciplinary scientific, clinical and regulatory teams, with direct exposure to the Chief Medical Officer and executive leadership.

• Science-driven, entrepreneurial environment offering substantial strategic responsibility and professional growth.