Senior Medical Director, Head of Medical Safety Science
16 days ago
Waltham
Job Description Position Summary: Apellis Drug Safety and Pharmacovigilance is responsible for all aspects of patient safety including single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and compliance with global regulatory requirements. Key Responsibilities of the Senior Medical Director and Head of Medical Safety Science are focused on leading a team of Safety Physicians and PV Scientists, providing strategic leadership for Medical Safety Science-related activities, representing Drug Safety and PV and Medical Safety Science on cross-functional teams, and representing the Head of Drug Safety and PV as directed. Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided. Key Responsibilities Include: • Managing, supporting and mentoring a team of Safety Physicians and PV Scientists,, • Lead safety activities and benefit-risk strategies for products/compounds in the Company's portfolio,, • Oversee, and support team members in the preparation, and/or review of aggregate safety review documents (such as Development/Periodic Safety Update Reports) and safety sections of relevant clinical trial documents (e.g., protocols, Investigator brochures, informed consent forms),, • Supervise the team in evaluation of signals emerging from any data source through case-series review, document analysis, safety topic reviews or other means of communication,, • Represent Drug Safety and Pharmacovigilance as the Safety Subject Matter Expert for input to regulatory product labeling and participate/provide input at labeling working group meetings, CCDS decisions and provide regional safety labeling support., • Support the EU QPPV or other regional or local Qualified Person for Pharmacovigilance relative to issues relating to assigned products., • Provide input to R&D publication strategy, publication plan, and ensure safety input to publications and presentations., • Act as the global safety lead for assigned compounds in development and provide safety lead support for global submission document production and review., • Support Safety Physicians and PV Scientists in medical safety development and execution of benefit-risk management strategies for products/compounds in the Company's portfolio., • Provide safety input to clinical development plans, study protocols, amendments, investigator brochure, statistical analysis plans, informed consent, clinical study reports, responses to queries from health authorities or ECs/IRBs as needed., • Provide leadership to Safety Physicians and PV Scientists in the development of safety risk language, risk management plan, pre-submission safety activities including safety table shells, integrated safety summary documents, and safety-focused publications., • Ensure medical safety review of development safety update reports, annual reports and other periodic safety reports., • Actively drive safety strategy preparation for pre-NDA meetings, Advisory Committee meetings, Scientific Advice meetings, and DMC meetings., • Provide medical safety, benefit-risk input and approve periodic safety update reports, product renewal submissions, postmarketing study documents and reports, and responses to health authority queries., • Provide medical safety leadership, oversight of and execution of risk management strategies and RMP elements for Company's portfolio inclusive of development of educational materials, and measures of effectiveness., • Provide leadership and support for safety signal management (inclusive of detection, evaluation, assessment, communication). Review results of signal evaluation as directed by Head of Drug Safety and PV., • Supervise the preparation of and review of regulatory responses., • Provide postmarketing safety study guidance on pharmacoepidemiology topics including but not limited to investigator-initiated studies, epidemiology studies, non-interventional safety studies., • Ensure safety labeling adequately reflects emerging postmarketing safety profile., • Leads the Medical Safety Science team in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within Drug Safety and Pharmacovigilance and R&D, including authoring of procedural documents., • Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates., • Assist the team and senior leadership in all forms of issue management and crisis management., • Support hiring, orientation, management, mentorship, and development of staff., • Provide input to strategic plans for safety differentiation of company products., • Coordinate training to employees on product safety profiles/issues., • Provide input to due diligence and potential in-licensing opportunities as requested., • Provide product-based cross-functional liaison., • Support manufacturing quality and provide quality incident medical assessments., • A minimum of 12 years of progressive clinical development and postmarketing experience, preferably in pharmacovigilance, at a pharmaceutical or biotechnology company., • Experience managing teams required., • Experience with managing nephrology or ophthalmology products preferred., • Broad experience in clinical trial design (phases 1 to 3) and clinical data interpretation., • Working knowledge of FDA and EMA regulatory landscapes, GCP, and ICH guidelines., • Excellent verbal communication and presentation skills. This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Travel Requirements: Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit to learn more. Company Background: Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit or follow us on Twitter and LinkedIn EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law. For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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