Our client is a clinical-stage biopharmaceutical company advancing innovative small molecule therapies for genetically defined rare diseases. They have asked us to assist them in their search for a Senior/Executive Director Pharmacovigilance.

Major tasks and responsibilities include:

• Serve as our client’s internal subject matter expert for clinical safety and pharmacovigilance.
• Work with an enterprise mindset to help support corporate goals by finding innovative regulatory/safety pathways towards commercialization.
• Develop, implement, and oversee global safety strategies for clinical programs focused on rare diseases.
• Responsible for ensuring compliance with global regulatory agencies safety reporting requirements.
• Lead safety signal detection, risk evaluation, mitigation strategies, and safety-related content for regulatory submissions and filings (INDs, IBs, DSURs, NDAs).
• Chair Safety Review Teams and provide real-time clinical safety assessments throughout the development lifecycle.
• Collaborate with CROs managing the safety database and ensure robust vendor oversight.
• Interface with regulatory agencies as the company’s clinical safety lead during meetings and submissions.
• Work cross-functionally with Clinical Development, Regulatory, Biostats, and Preclinical teams to optimize safety data collection and interpretation.
• Guide development of safety-related SOPs and contribute to inspection readiness efforts.
• Mentor and/or oversee internal and external safety team members and consultants.

We seek candidates with the following qualifications:

• Medical Degree required.
• Experience practicing medicine in a clinical setting is strongly preferred.
• Significant experience supporting safety/PV activities for clinical development stage programs.
• Prior experience interpreting AEs/SAEs in high acuity patients.
• Demonstrated program leadership capabilities.
• Prior experience advancing programs from first-in-human through pivotal trials strongly preferred.
• Strong analytical skills and ability to interpret complex clinical and safety data.
• Experience with small molecules and rare diseases is strongly preferred.
• Experience interacting with regulatory agencies (FDA, EMA) regarding safety matters.
• Familiarity with GxP, ICH, and global pharmacovigilance regulations.
• Effective communicator and cross-functional collaborator, capable of translating complex safety signals into actionable decisions.
• Must be local to the Boston/Cambridge area or willing to relocate; expected onsite presence ~50%.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.