Director, Drug Safety Operations

Parabilis Medicines•Cambridge, MA

19h•$200,000 - $240,000

About The Position

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities. Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs. What’s the opportunity? The Director, Drug Safety Operations/Pharmacovigilance (PV) will lead and oversee safety reporting activities across clinical programs, with a primary focus on managing and coordinating pharmacovigilance deliverables with Contract Research Organizations (CROs) and consultants. This role ensures compliance with global regulatory requirements, company SOPs, and high-quality execution of safety reporting obligations. This position will act as the key liaison between internal stakeholders and CRO partners and consultants to drive operational excellence and regulatory compliance in pharmacovigilance activities. The successful candidate will report to the VP of Clinical Safety and Pharmacovigilance.

Requirements

Master’s degree or higher in a healthcare field.
10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role.
Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance oversight.
Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements.
Experience with oversight of drug safety databases (e.g., Oracle Argus).
Proven track record of ensuring compliance in a global PV environment.
Build and maintain excellent interpersonal relationships, both within and outside the company, at all levels, and work within, lead and motivate a cross-functional matrixed team.
Self-motivated; engaged, hands-on, entrepreneurial style with a sense of urgency, a bias toward action, and flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas.
Analytical and problem-solving skills; risk identification and management; creative and innovative thinking.
The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders.
Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity.
Excellent communication, negotiation, and leadership skills.

Responsibilities

Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).
Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations.
Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants.
Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators.
Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance.
Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants.
Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness.
Support development and maintenance of internal PV policies, SOPs, and training programs.
Participate in safety signal detection activities and safety governance committees, as needed.
Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.