About this opportunity
Pretzeltx lists this Sr. Director, Pharmacovigilance / Product Safety (MD) opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Sr. Director, Pharmacovigilance / Product Safety (MD)
Boston, MA, USA
HYBRID
EXEMPT
REPORTING TO THE CHIEF DEVELOPMENT OFFICER
COMPANY OVERVIEW
Pretzel Therapeutics is a biotechnology company headquartered in Boston, Massachusetts, with research facilities in Mölndal at GoCo House, part of GoCo Health Innovation City. Pretzel Therapeutics is dedicated to developing life-changing medicines with a broad pipeline of first-in-class treatments addressing novel targets within the mitochondria. By harnessing cellular energetics to modulate disease processes and improve survival, function and quality of life, we are ushering in a new treatment paradigm for a breadth of conditions spanning neurological, muscle, metabolic and rare diseases.
POSITION SUMMARY
The Sr. Director, Pharmacovigilance / Product Safety (MD) will provide strategic and medical leadership for pharmacovigilance and product safety across Pretzel Therapeutics’ clinical development portfolio. This individual will be responsible for establishing and executing safety strategies, providing medical oversight of safety surveillance, and ensuring the appropriate identification, assessment, management, and communication of safety risks throughout clinical development.
The Sr. Director will serve as Pretzel’s senior medical safety expert and partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, and other cross-functional stakeholders to ensure patient safety, rigorous benefit-risk assessment, and compliance with applicable global pharmacovigilance requirements. This role will provide safety leadership to development teams and governance forums and ensure appropriate pharmacovigilance capabilities, processes, and external partnerships are in place as Pretzel’s programs advance through development.
KEY RESPONSIBILITIES
Provide strategic and medical leadership for pharmacovigilance and product safety activities across Pretzel’s clinical development portfolio
Develop and execute program-level safety surveillance strategies and ensure appropriate safety monitoring and risk management throughout clinical development
Lead medical assessment and oversight of serious and clinically significant safety events, emerging safety trends, potential signals, and other safety information requiring medical judgment
Lead signal detection, evaluation, management, and communication activities and provide recommendations regarding potential impact on clinical development programs
Provide medical and strategic oversight of aggregate safety reports, including DSURs and other required periodic safety assessments, and lead ongoing benefit-risk evaluation for assigned products
Provide senior safety leadership to Clinical Development and cross-functional program teams, including input into protocols, investigator brochures, informed consent forms, safety monitoring plans, regulatory submissions, and development strategies
Establish and oversee pharmacovigilance governance, processes, procedures, and infrastructure appropriate for Pretzel’s portfolio and stage of development
Provide sponsor oversight of external pharmacovigilance vendors and partners, including performance, quality, compliance, and delivery of safety activities
Represent Product Safety in cross-functional development and governance forums and communicate significant safety findings, emerging risks, and benefit-risk recommendations to senior leadership
Partner with Regulatory Affairs on health authority interactions, regulatory submissions, safety-related responses, and global reporting requirements
Ensure pharmacovigilance activities comply with applicable FDA and international regulations, ICH guidelines, company procedures, and established quality standards
Provide leadership for pharmacovigilance audits, inspections, inspection readiness, and resolution of significant safety or compliance findings
Identify evolving safety requirements and organizational needs and implement scalable processes and capabilities to support Pretzel’s advancing development portfolio
EXPERIENCE & QUALIFICATIONS
MD required
Minimum of 10-12 years of relevant pharmaceutical or biotechnology industry experience, including significant experience in pharmacovigilance, drug safety, clinical development, or a closely related function
Deep knowledge of global pharmacovigilance regulations, FDA requirements, ICH guidelines, safety reporting requirements, and industry best practices
Significant experience with safety signal detection and management, aggregate safety reporting, benefit-risk assessment, and safety governance
Demonstrated experience providing strategic safety input into clinical development plans, protocols, investigator brochures, regulatory submissions, and health authority interactions
Experience establishing or evolving pharmacovigilance capabilities, processes, governance, and external partnerships within a development-stage organization
Strong experience providing sponsor oversight of pharmacovigilance vendors, CROs, and other external partners
Demonstrated ability to interpret complex clinical and safety data, assess potential risks, and provide clear recommendations that influence development decisions
Strong leadership, communication, and influencing skills with the ability to effectively represent Product Safety with senior leadership and cross-functional development teams
Ability to operate strategically while remaining hands-on in a lean, fast-paced biotechnology environment
Results-oriented with strong medical judgment, accountability, and the ability to prioritize and lead multiple complex safety activities
Highly collaborative leader who fosters open communication, sound decision-making, and effective partnerships across internal and external stakeholders
BENEFITS
Pretzel offers a highly competitive compensation package, including base salary, annual bonus eligibility, incentive stock options, comprehensive health, dental, and vision coverage, 401(k), paid time off, company holidays, and an annual winter shutdown.
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.