Position Summary:

The Associate Medical Directorof Nephrology, reporting to the Sr. Medical Director of Nephrology, will be responsible for clinical development support for nephrology studies, including Phase 2 and 3 studies. This individual will work within cross-functional study teams to provide medical/clinical support for assigned studies, review and interpret clinical trial data, author clinical study and regulatory communications and reports, oversee the medical/clinical activities of CROs, and liaise with sites and principal investigators on medical/clinical questions related to clinical trials.

Key Responsibilities Include:

• Provide sponsor medical oversight for assigned clinical trials, with a focus on Phase 2 and 3 trials in nephrology.
• Monitoring, coding and cleaning of clinical trial data, in collaboration with relevant members of the cross-functional clinical trial team, including Clinical Operations and Data Management.
• Authoring clinical sections of regulatory documents including, but not limited to IND submissions, annual updates, study protocols, investigator brochures, briefing documents, and other study-relevant documents such as patient informed consent documents.
• Writing manuscripts, publications, or other documents intended for external audiences.
• Acting as an internal resource for functions requiring clinical input on select drug(s) including primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions.
• Supporting or preparing data interpretation and clinical trial reports.
• Contributing in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates.
• Contributing to Strategic or Clinical Advisory Boards and, supporting Medical Affairs as needed.

Education, Registration & Certification:

• MD or DO degree (or international equivalent) required, board certified nephrologist preferred

Experience:

• Minimum of 2 years of industry-based clinical development experience in a pharmaceutical or biotechnology setting.
• Experience initiating and managing clinical trials for industry is preferred.
• Ability to present complex medical data and concepts to a variety of audiences (medical, scientific, vendors) in a credible and engaging manner.
• Strong technical/analytical skills to identify and solve problems.
• Demonstrated application of critical thinking skills.
• Proven ability to multitask, prioritize and execute corporate objectives and goals.
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion, while knowing one’s limitations and when to seek support or advice.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail.
• Capable of proactively seeking out and recommending process improvements.
• Enjoys working in a fast-paced, small-company environment.
• Must enjoy and function well as part of a multi-functional team.

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.