Senior Director / Executive Director, Medical Safety Leader

Location: Boston, MA or Philadelphia, PA
Therapeutic Area: Immunology & Inflammation
Company: Confidential, AI-Enabled Biotechnology Company
Degree Requirement: MD or MD/PhD

The Opportunity

An innovative, rapidly scaling biotechnology company is seeking a Senior Director / Executive Director, Medical Safety Leader to provide medical and scientific leadership for an emerging portfolio of biologic and oral therapies targeting immunology, inflammation, and difficult-to-treat immune-mediated diseases.

The organization combines advanced disease biology, AI-enabled drug discovery, biologics engineering, and clinical development expertise to pursue differentiated therapies for patients with significant unmet needs. The company is approaching an important stage of growth as its first wave of programs advances from preclinical development toward first-in-human studies and clinical proof of concept.

Reporting to the Chief Medical Officer, the Medical Safety Leader will be accountable for the integrated safety strategy across the portfolio. This individual will translate emerging nonclinical and clinical data into clear benefit-risk assessments, risk-management actions, protocol safeguards, and development recommendations.

This opportunity is particularly well suited for an accomplished physician safety leader who brings the scientific rigor, global development experience, and governance discipline gained within large pharma, along with the hands-on mindset required to establish and scale capabilities in an emerging biotechnology organization.

Key Responsibilities

Global Medical Safety Strategy

• Develop and lead the integrated medical safety and benefit-risk strategy across the company's portfolio.
• Provide safety leadership from candidate selection and IND/CTA-enabling development through first-in-human studies, proof of mechanism, proof of concept, and later-stage development.
• Define product-specific safety objectives, identified and potential risks, monitoring plans, decision criteria, mitigation measures, and evidence requirements.
• Translate evolving safety data into clear recommendations for program teams, executive leadership, and governance committees.
• Ensure patient safety remains central to portfolio prioritization and clinical development decisions.

Preclinical Translation and First-in-Human Development

• Integrate nonclinical toxicology, pharmacology, PK/PD, exposure-response, biomarker, and modality-specific findings into clinical safety strategies.
• Contribute medical safety expertise to first-in-human dose selection, safety margins, dose-escalation plans, stopping rules, and risk-mitigation strategies.
• Lead safety input into INDs, CTAs, investigator brochures, informed consent forms, and early clinical development plans.
• Partner with Toxicology, Translational Medicine, Clinical Pharmacology, CMC, Regulatory Affairs, and Clinical Development to evaluate emerging risks and establish appropriate clinical safeguards.

Clinical Safety and Pharmacovigilance

• Direct ongoing safety surveillance across clinical programs, including adverse events, serious adverse events, adverse events of special interest, laboratory trends, immunogenicity, and modality-specific risks.
• Lead signal identification, evaluation, validation, prioritization, and management through resolution.
• Oversee medical review of individual safety cases, including causality, seriousness, expectedness, and clinical interpretation.
• Evaluate cumulative and emerging safety data to inform benefit-risk assessments, development strategy, and regulatory communication.
• Establish safety review processes and escalation pathways appropriate for a growing clinical portfolio.

Immunology and Inflammation Safety Leadership

• Provide medical safety expertise across immune-mediated diseases, potentially including:
  • Dermatology
  • Rheumatology
  • Gastroenterology
  • Respiratory and inflammatory disease
  • Systemic autoimmune conditions
• Apply a sophisticated understanding of immune biology, class effects, immunogenicity, infection risk, immune modulation, and other relevant safety considerations.
• Assess safety risks associated with biologic modalities, including antibodies and multispecific molecules, as well as oral therapeutic agents.
• Partner with Clinical Development and Translational Medicine to distinguish disease-related findings from treatment-emergent or mechanism-based safety signals.

Protocol and Clinical Development Support

• Partner with Clinical Development and Clinical Operations to shape protocol design, eligibility criteria, dose escalation, monitoring plans, adverse-event management, and trial-conduct decisions.
• Review clinical protocols, safety-monitoring plans, investigator brochures, and informed consent documents to ensure appropriate safeguards.
• Provide real-time medical leadership in response to emerging safety events and potential changes to clinical trial conduct.
• Support dose-modification guidance, temporary holds, stopping criteria, and risk-mitigation decisions.
• Represent Medical Safety on cross-functional clinical and product-development teams.

Aggregate Reporting and Regulatory Strategy

• Provide medical leadership for aggregate safety reports, including:
  • Development Safety Update Reports
  • Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports
  • Risk Management Plans
  • Reference Safety Information
  • Clinical overviews and integrated safety summaries
  • Investigator brochure safety updates
• Lead medical safety input into INDs, CTAs, BLAs, NDAs, and responses to regulatory authorities.
• Represent Medical Safety in interactions with the FDA, EMA, NMPA, and other global health authorities.
• Clearly communicate and defend safety assessments, signal evaluations, benefit-risk conclusions, and proposed risk-management actions.

Safety Governance and Executive Communication

• Serve as the company's senior medical safety expert to executive leadership, governance committees, data and safety monitoring boards, external advisors, partners, and health authorities.
• Establish fit-for-purpose safety governance structures, including review forums, decision rights, escalation criteria, and documentation standards.
• Present complex safety information in a clear, balanced, and actionable manner to scientific, clinical, regulatory, and business stakeholders.
• Lead benefit-risk discussions at critical development and portfolio milestones.
• Support external advisory boards and independent safety committees as required.

Pharmacovigilance Infrastructure and Vendor Oversight

• Build and scale the organization's pharmacovigilance capabilities as the pipeline progresses.
• Establish or enhance safety SOPs, medical-review standards, case-assessment processes, signal-management procedures, and inspection-ready documentation.
• Select and oversee external pharmacovigilance vendors, CROs, consultants, and safety-system partners.
• Ensure individual case safety reports are medically sound, complete, consistent, and submitted within applicable regulatory timelines.
• Establish clear vendor oversight, quality metrics, escalation pathways, reconciliation processes, and governance expectations.
• Support the development and management of Safety Data Exchange Agreements with partners and licensees.

Business Development and Alliance Support

• Evaluate safety liabilities, class effects, nonclinical findings, and benefit-risk profiles for potential licensing, partnership, and acquisition opportunities.
• Provide medical safety leadership during due diligence and external asset evaluations.
• Support alliance-management activities by establishing safety accountabilities, governance structures, and data-exchange expectations.
• Represent the organization in safety discussions with current and prospective development partners.

Ideal Candidate Profile

Education and Medical Training

• MD or MD/PhD, or an equivalent medical degree, is required.
• Clinical training or significant development expertise in Immunology & Inflammation or related immune-mediated diseases is strongly preferred.
• Board certification or advanced specialty training in a relevant field would be advantageous.

Professional Experience

• Significant pharmaceutical or biotechnology experience in Medical Safety, Pharmacovigilance, or safety-focused Clinical Development.
• Extensive experience within a large global pharmaceutical organization is strongly preferred.
• Demonstrated safety leadership across multiple stages of development, ideally spanning preclinical translation, first-in-human development, proof of concept, and later-stage clinical programs.
• Deep therapeutic expertise in Immunology & Inflammation, with strong consideration given to candidates experienced in dermatology, rheumatology, gastroenterology, respiratory disease, or systemic autoimmune conditions.
• Experience supporting global clinical development programs and working with multidisciplinary teams across the United States, Europe, and potentially China.
• Experience with biologics, including monoclonal antibodies or multispecific molecules, is strongly preferred. Exposure to oral therapeutic modalities would be beneficial.

Technical Expertise

• Deep expertise in medical case review, signal detection, signal management, aggregate safety reporting, benefit-risk assessment, and risk-management planning.
• Strong understanding of global pharmacovigilance regulations and clinical safety requirements.
• Experience authoring or providing medical leadership for DSURs, PSURs/PBRERs, RMPs, reference safety information, regulatory submissions, and health-authority responses.
• Ability to integrate clinical, nonclinical, toxicology, PK/PD, biomarker, immunogenicity, and CMC findings into coherent product safety strategies.
• Experience leading safety interactions with global regulatory authorities.
• Demonstrated success governing external pharmacovigilance providers and maintaining high standards for case quality, compliance, and operational execution.
• Experience with Safety Data Exchange Agreements, licensing due diligence, and pharmacovigilance infrastructure development is desirable.

Leadership Profile

The ideal candidate is a decisive and highly credible physician leader who can move seamlessly between individual case-level analysis and portfolio-level safety strategy.

This individual will bring mature medical judgment, an objective and patient-centered approach to benefit-risk assessment, and the ability to make clear recommendations when working with emerging or incomplete datasets. The successful candidate must be comfortable challenging assumptions, escalating concerns, and influencing senior stakeholders across functions and geographies.

The preferred profile combines the global safety standards and development discipline of large pharma with the adaptability, pace, and hands-on leadership required in a scaling biotech. This leader should be equally comfortable reviewing a complex safety case, guiding a cross-functional signal assessment, presenting to executive leadership, engaging with a health authority, and building the infrastructure needed to support future portfolio growth.

Why Consider This Opportunity?

This is an opportunity to shape the medical safety function at a defining stage in the company's growth.

The selected leader will have significant influence over:

• Safety strategy across an emerging I&I portfolio
• First-in-human and proof-of-concept development decisions
• Benefit-risk assessment and signal-management standards
• Clinical protocol safeguards and patient-monitoring strategies
• Global regulatory positioning
• Pharmacovigilance infrastructure and vendor strategy
• The organization's broader safety culture

Candidates must be based in, or able to work from, Boston, MA or Philadelphia, PA.

Salary: 280-360,000 base salary + additional incentives