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Director, Clinical Science

companyApellis
locationWaltham, MA, USA
PublishedPublished: 6/14/2022
Full Time

Job Description

Position Summary:

The Director, Clinical Science, Ophthalmology is a key member of our clinical development team and is a major contributor to the development and execution of the clinical strategy for our ophthalmology programs. The successful candidate will interface with the entire clinical team to provide scientific expertise and will also have opportunities to make strategic and scientific impacts on current and future clinical programs.

Key Responsibilities Include:

  • Lead the clinical development team on the review, analysis, interpretation and presentation of accurate study results.
  • Contribute to the design and execution of clinical studies in close collaboration with Clinical Operations.
  • Lead cross-functional collaboration with regulatory, data management and biostats departments.
  • Remain up to date on current regulations, guidelines and scientific advances relevant to Apellis.
  • Facilitate cross-functional collaboration with Translational Medicine to transition research stage assets to clinical development.
  • Contribute to drafting manuscripts and other publications and presentations.
  • Provide support for advisory boards, consultant meetings, and investigator meetings including preparation and/or delivery of presentations.
  • Cultivate relationships with external partners such as clinical investigators, clinicians, and scientists in support of innovation and business development.
  • May require travel to field sites, internal and external meetings and conferences.

Education, Registration & Certification:

  • MS/PhD in related life science discipline, with relevant clinical development experience in ophthalmology.

Experience:

  • 8+ years of clinical development and safety experience in the pharmaceutical/biotech industry.
  • Previous experience in ophthalmology is required.
  • Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
  • Experience interacting with clinical investigators and medical experts.
  • Experience with regulatory submissions, regulatory agency meetings.

Skills, Knowledge & Abilities:

  • Comfortable working independently with minimal supervision.
  • Highly organized, results driven, problem solver with ability to synthesize, organize, manage and communicate safety data from various sources.
  • Superior written and oral communication skills and the ability to work collaboratively and build relationships with colleagues from different levels of the organization.
  • Highly motivated with the ability to be flexible in a 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:

  • 20-25% 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.

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