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Mythic Therapeutics - Waltham, MA
posted 4 days ago
About the position
The Director/Sr. Medical Director, Drug Safety & Pharmacovigilance (PV), is responsible for: 1) the collection, detection, assessment, monitoring, and prevention of adverse effects with Company's drug candidates; and 2) the strategic development and oversight of the Company's Pharmacovigilance function/program and is accountable for the design and implementation of the PV infrastructure to support a variety of core medical activities including the management of safety signal, risk management, and benefit-risk strategies for Mythic's pipeline of novel ADC therapeutics. The role will provide input and overview on PV regulatory documents and strategy in compliance with all relevant regulatory requirements. This role will have responsibility for all internal and outsourced PV activities and will be a key member of the Product Development Team (PDT). This position will report directly to the Chief Development Officer.
Responsibilities
- Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements.
- Assist in the preparation of safety reports to be submitted to regulatory agencies.
- Monitor and assess the risks and benefits of Company's drug candidates to patients.
- Lead the development and execution of risk management plans.
- Liaise with Data Management and Clinical to ensure integrity of safety data.
- Collect additional information on adverse events from healthcare professionals/investigational sites and other stakeholders as needed.
- Communicate with regulatory authorities, healthcare professionals, and other stakeholders on safety-related issues.
- Long-term strategic planning for PV including creation of PV roadmap and budget.
- Provide strategic advice for the delivery of PV related study support for all clinical trials.
- Participate in the development and implementation of safety policies and procedures.
- Author required PV SOPs and review non-PV SOPs with PV touchpoints.
- Facilitate and support the build of PV QMS including SOP development, inspection readiness, metrics development, and governance structure.
- Lead development of Safety/PV regulatory documents and strategy per global regulations.
- Monitor safety literature for aggregate safety reporting.
- Co-lead the preparation of internal and external safety governance meetings.
- Collaborate with other departments to ensure compliance with safety regulations and guidelines.
Requirements
- Education: MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent) or equivalent required.
- Experience: Over 5 Years relevant experience in Drug Safety/Benefit Risk Management.
- Competencies: Oncology Therapeutic Expertise, Drug Development, Clinical Trials Experience, Scientific Knowledge, Strategic and Critical Thinking, Influencing Skills, Team Leadership in a cross-functional team environment.
- Good oral and written English communication and presentation skills.
- Experience with global clinical trial conduct.
Benefits
- Top-notch benefits package
- Work/life integration
- Professional development opportunities
