Medical Director, Ophthalmology - Safety and Benefit Risk Management

Job Description

Job Description

Position Summary :

The Medical Director, Ophthalmology - Safety and Benefit Risk (SABR) 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.

The Medical Director is a critical part of this function providing safety and benefit risk management strategies across Apellis products and programs.

They are the Safety Medical lead for all safety activities. Reporting to the Head of Medical Safety Science, the Medical Director will serve as the Medical Safety Lead for Apellis ophthalmology products.

Key Responsibilities Include :

• Collaborate with relevant functions, the Medical Director will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products.
• The Medical Director will communicate potential and known risks, when appropriate, to Chief Medical Officer (CMO), Pharmacovigilance team including the Qualified Person for Pharmacovigilance (EU QPPV) as applicable, Senior Management, Health Authorities (HA), prescribers and / or patients.
• Lead safety activities and benefit-risk strategies for assigned compounds and chair the product safety signal management (SSMT) team meeting.
• Perform ongoing safety data review and analysis for products in the therapeutic areas of ophthalmology.
• Lead team in evaluation of signals emerging from any data source through case-series review, document analysis, safety topic reviews or other means of communication.
• Provide input to R&D publication strategy, publication plan, and ensure safety input to publications and presentations.
• Lead medical safety development and execution of benefit-risk management strategies for assigned products.
• 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.
• Provide medical safety, benefit-risk input and approve periodic safety update reports, product renewal submissions, post marketing study documents and reports, and responses to health authority queries.
• Lead or actively participate in department-wide initiatives.

Education, Registration & Certification :

Healthcare Professional (HCP) or Physician (MD or equivalent) with a minimum of 2 years of pharmacovigilance experience or other relevant experience (e.

g. Clinical research, Medical Affairs)

Experience :

• Experience in ophthalmology, experience in retinal disease is a plus.
• Demonstrated experience with medical assessments and medical monitoring activities.
• Experience with ophthalmology clinical development including risk / benefit analysis and safety assessment.
• Able to plan work to meet deadlines and effectively handle multiple priorities.
• Strong analytical, problem solving and scientific writing and communication skills.

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 great benefit package which includes : health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, 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.