Medical Director, Medical Safety Science

Position Summary:

Reporting to the Head of Medical Safety Science (MSS), the Medical Director, Medical Safety will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). The individual will closely collaborate internally with other functions (e.g., Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Development, and other Program Teams) and Contract Research Organizations (CROs) and Collaboration partners. The Head of Medical Safety Science (MSS), the Medical Director, Medical Safety will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

Key Responsibilities Include:

• Provide medical expertise/guidance in the assessment of ICSRs and aggregate drug safety reports.
• Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports.
• Contribute to and Oversight of safety signal and management processes, including the identification of safety observations, emergent safety concerns and new safety signals, ensuring prompt assessment and communication of confirmed safety signals.
• Serve as a medical resource for the generation of and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI).
• Contribute to creation and/or updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents.
• Contribute to the development of Standard Operating Procedures, Working Instructions, and other guidance documents.
• Contribute to safety and pharmacovigilance training programs. Provide safety training at investigator meetings.
• Collaborate with Medical Monitors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials.
• Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
• Provides strategic planning, implementation, and management of drug safety activities to support clinical development of the Apellis pipeline.
• Lead role in responding to safety questions and request for information from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
• Manages external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.

Education, Registration & Certification:

• Medical Degree (MD) from recognized medical school or international equivalent.

Experience:

• 5+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.

Skills, Knowledge & Abilities:

• Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
• Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.
• Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
• Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER).
• Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval.
• Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels.
• Ability to build relationships, collaborate and influence across disciplines within Apellis and with outside stakeholders.
• Experience with MedDRA coding, Points to Consider, AOSE, and SMQs.
• Excellent verbal, written and presentation skills.
• Natural ability to communicate and influence effectively to varied audiences.
• Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations while leading others through ambiguity and change.
• Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
• Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills.
• Effective team player, who fosters collaboration within and across functional areas.
• Sound strategic evaluation, analysis, and decision-making skills.
• Ability to work in a dynamic, fast paced environment.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. 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:

• Up to 20% travel expected.

Benefits and Perks:

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 https://apellis.com/careers/ 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 http://apellis.com 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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