Vice President, Pharmacovigilance
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera leverages its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA® (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability—empowering individuals to challenge the unknown together.
About the Role
We are seeking a strategic and accomplished Vice President, Pharmacovigilance to lead Deciphera’s global drug safety and pharmacovigilance function. This executive leader will be accountable for patient safety, regulatory compliance, and proactive benefit-risk assessment across investigational and marketed products. The VP will set the vision for safety governance, product safety strategy, risk management, regulatory safety support, and pharmacovigilance operations while partnering closely across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Technical Operations, and other key functions.
Responsibilities
- Develop and execute the global pharmacovigilance strategy in alignment with corporate objectives, regulatory requirements, and Deciphera’s commitment to patient safety.
- Provide executive leadership for benefit-risk evaluation, safety governance, safety surveillance, signal management, and risk management across investigational and marketed products.
- Serve as a senior safety advisor to executive leadership and represent Pharmacovigilance in governance committees, leadership forums, and interactions with health authorities.
- Ensure global pharmacovigilance activities are compliant, inspection-ready, scientifically rigorous, and aligned with applicable regulatory requirements, GCP standards, and internal quality systems.
- Establish and evolve scalable pharmacovigilance systems, processes, quality frameworks, vendor partnerships, and operational capabilities to support a growing global portfolio.
- Build, develop, and lead a high-performing pharmacovigilance organization while fostering a culture of scientific excellence, accountability, collaboration, and patient-focused decision making.
Requirements
- MD, DO, PharmD, PhD, or equivalent advanced scientific or healthcare degree.
- 15+ years of progressive experience in pharmacovigilance, clinical safety, drug safety, or drug development within the biotechnology or pharmaceutical industry.
- 8+ years of leadership experience managing global pharmacovigilance, clinical safety, or patient safety organizations.
- Demonstrated experience supporting products across clinical development and commercialization.
- Deep understanding of global pharmacovigilance regulations, guidelines, and industry best practices, including FDA, EMA, ICH, GCP, and other applicable requirements.
- Experience with safety governance, benefit-risk assessment, signal detection, risk management, safety reporting, and inspection readiness.
- Track record of successful health authority interactions, regulatory inspections, audits, and cross-functional safety leadership.
- Strong strategic leadership, communication, decision-making, and stakeholder management skills.
Preferred Qualifications
- Oncology experience strongly preferred.
- Experience supporting small molecule therapeutics.
- Prior experience leading pharmacovigilance activities for commercial-stage products.
- Experience working in a global, outsourced operating model utilizing CROs and external pharmacovigilance vendors.
- Demonstrated success building, scaling, and evolving pharmacovigilance organizations, systems, and operating models.
- Experience supporting regulatory submissions, product launches, and post-marketing safety activities in multiple global markets.
- Strong business acumen with the ability to align safety strategy with corporate objectives.
Pay
The base salary pay range for this role is $335,000-$460,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
- Equity-based compensation and long-term incentive plan.
- Flexible spending account for either health care and/or dependent care.
- Life insurance.