Head of Pharmacovigilance

Head of Pharmacovigilance

Damora Therapeutics has hubs in Waltham, MA and San Francisco, CA, and is open to remote hiring.

OUR COMPANY

Who We Are

Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for new disease-modifying treatments. With multiple programs with best-in-class potential entering clinical development, our goal is to rapidly bring forward optimized treatments with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes.

THE OPPORTUNITY

The Role

• As Damora advances several assets into the clinic in essential thrombocythemia and myelofibrosis, patient safety has to be built into every program decision. We are looking for a senior pharmacovigilance leader to establish and run Damora's safety strategy, systems, and governance from the clinic through registration.
• Reporting to the Chief Medical Officer, the Vice President, Head of Pharmacovigilance owns Damora's global PV strategy and is accountable for the safety of patients in our trials and for compliance with global safety regulations. You will lead safety surveillance, signal detection, and benefit-risk assessment, oversee case processing and PV vendors, and be the safety voice with regulators, data monitoring committees, and clinical leadership.
• This is a build-and-lead role in a small, clinical-stage company: you will set the operating model, hire the team, and stay close to the work.

RESPONSIBILITIES

What You'll Do

Safety Strategy & Governance

• Set and lead Damora's global pharmacovigilance and safety strategy for the pipeline, aligned with clinical development and regulatory plans.
• Strengthen and sustain safety governance, establishing or refining the safety review committee, escalation paths, and decision rights as needed, and chair safety reviews with clinical leadership.
• Provide safety input to clinical development plans, protocols, and informed consent, and lead safety strategy for the Investigator's Brochure and reference safety information and, in time, product labeling, including drug class and competitor safety learnings.
• Partner with the CMO and Clinical Development on benefit-risk positioning and safety-related program decisions.

Safety Surveillance & Risk Management

• Oversee safety signal detection, evaluation, and escalation across all studies, including review of emerging literature and partner and competitor safety data, and lead benefit-risk assessments and risk management planning.
• Hold medical accountability for the review and assessment of serious adverse events and SUSARs, including secondary medical review of individual case reports, and guide PV vendor case processing teams.
• Serve as the PV lead for data monitoring committees and safety review boards, preparing safety data and recommendations.

PV Operations, Systems & Vendors

• Oversee case intake, processing, and reporting, whether performed in-house or by PV vendors, so expedited reports meet global timelines.
• Select, contract, and govern PV vendors and safety technology, with KPIs, quality agreements, and regular performance reviews.
• Own the PV budget and resource plan, and build SOPs and quality documentation that scale with the pipeline.

Regulatory Compliance & Inspection Readiness

• Ensure compliance with FDA, EMA, ICH, and other global PV requirements, including expedited reporting, DSURs, and other aggregate safety reports.
• Lead safety content for INDs, CTAs, and, in time, BLA submissions, including the integrated summary of safety.
• Represent PV with health authorities and lead the function through audits and inspections, in partnership with Regulatory Affairs and Quality.

Team Leadership & Cross-Functional Partnership

• Build and lead the PV and safety science team, starting with a Safety Scientist, and set the structure and hiring plan as programs grow.
• Partner with Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Quality, and Medical Affairs so safety insight shapes study design and execution.
• Review safety content in publications, presentations, and investor and regulatory materials.

QUALIFICATIONS

You'll Bring

• M.D. or international equivalent.
• 10+ years of experience in biotech, pharma, or a regulatory agency, with 5+ years in pharmacovigilance or risk management, including experience leading teams.
• In-depth knowledge of global PV regulations and guidance (FDA, EMA, ICH E2 series, GVP), and experience building compliant PV systems for clinical-stage programs.
• Expertise in signal detection, benefit-risk assessment, risk management, and aggregate safety reporting (for example DSURs and the safety sections of INDs and BLAs).
• Experience selecting and overseeing outsourced PV vendors, safety databases, and case processing.
• Experience engaging health authorities on safety topics and contributing to registration documents, such as clinical study reports and integrated summaries of safety.
• A builder who is strategic and hands-on, comfortable making clear safety calls without every answer, and who communicates candidly with executives and study teams.

Preferred

• Experience in hematologic malignancies, including myeloproliferative neoplasms, or other serious blood disorders.
• M.P.H. or epidemiology training or experience.
• Experience with biologics or monoclonal antibodies.
• Experience with EU and ex-US pharmacovigilance requirements, including QPPV responsibilities.
• Clinical trial development and execution experience, including supporting data monitoring committees.
• Prior experience building a PV function at a clinical-stage biotech, ideally through to a first BLA.

OUR VALUES

How We Work

Our purpose: we make more possible for people. We stay connected to who we serve, see the person beyond the disease, and work for the moments that matter. Four values guide how we work:

Impact. We raise the bar. We're here to aim high, build something meaningful and make a difference that matters.

Together. We show up for each other. We trust each other, learn from each other, and create more together than we could alone.

Courage. We keep going when it counts. We move forward, take risks worth taking, and learn and adapt when the path changes.

Thrive. We take the work seriously, not ourselves. We bring lightness to hard work, make great work sustainable, and empower each other to thrive.

TOTAL REWARDS

Compensation & Benefits

At Damora Therapeutics, we offer competitive compensation and thoughtfully designed total rewards aligned with industry benchmarks. We believe in rewarding impact and building meaningful ownership for our team.

A NOTE FOR AGENCIES

We are building our team intentionally and do not accept unsolicited resumes from recruiting or staffing agencies. Agencies should not submit candidates unless directly engaged by Damora's HR team and operating under a signed agreement. Any resume submitted without prior authorization and a signed agreement will be considered property of Damora Therapeutics, and no referral or placement fees will be paid.

Damora Therapeutics is an Equal Opportunity Employer.