Senior Director, Translational Development

Position Summary

The Senior Director of Translational Medicine holds the responsibility of serving as the biomarker/digital health outcomes project leader for development programs and will drive translational medicine strategy across multiple early-stage programs. In close collaboration with research, clinical development and commercial functions, this individual will deliver ‘fit for purpose’ exploratory biomarker & digital asset strategies and leverage biomarker/digital asset outputs to inform drug development strategies, support early stage go/no go decision making, and design efficient clinical trial design across multiple therapeutic areas.

Key Responsibilities Include

• Cross-functionally collaborate to drive deeper understanding of disease and compound mechanistic biology, identify clinical decision-making exploratory biomarkers & digital health outcomes, and define precision medicine hypotheses.
• Work within a matrixed team of Biomarker/Endpoint and cross-functional experts, develop translational strategies designed to support alternative endpoints (e.g., biomarkers and digital health readouts) in early state go/no go decision making, clinical development plans, the regulatory path, and commercialization.
• Define the biomarker/digital health strategy for asset(s), translating the preclinical discovery efforts into a clinical fit for purpose plan, oversee the integration into the clinical protocol and lead the review and discussions across multiple forums.
• Lead or participate in external meetings with authorities and ethics committees, and with external key opinion leaders.
• Work in close alignment with preclinical, translational and clinical project teams to implement precision medicine approaches in order to shape drug development strategies, optimize study designs, enable early derisking and successful approval, including contributing to clinical protocol development, investigator brochures, and associated regulatory documents.
• Represent Translational Medicine on cross-functional teams and contribute to integrated, strategic drug development decision making in research and clinical development (GO/NO GO decisions for early stage assets and along clinical development pipeline), indication selection, and other relevant milestones.
• Co-leading strategic translational data working groups centered on integrating and analyzing large-scale patient multi-modal data sets (clinical, omics, imaging, digital, etc.) to identify key translational/biomarker/digital asset hypotheses for treatment response (or non-response), evaluate endpoints, and identify potential responder patient subpopulations.
• Identify opportunities by partnering in external teams across Pharma/biotech (clinical research through healthcare applications), academic institutions, biobanks, or commercial business functions to access real-world data to generate impactful data and insights.
• Support business development by contributing to evaluation of data packages for in-licensing opportunities, and building data-driven hypotheses for new target, drug repositioning to disease indication expansion, and functional differentiation of Apellis’ targets from competitors.
• Collaborate with research leaders to provide strategic oversight for portfolio development and be able to anticipate and proactively address translational gaps.
• Is an enterprise partner and strategic leader in the matrix environment, able to integrate and represent projects in the internal/external scientific discussions and initiatives.
• Partner with Research & Discovery to identify and characterize novel biomarker endpoints/digital health readouts in pre-clinical and early development studies.
• Leverage expertise across multiple therapeutic areas including neurologic, ophthalmologic, and nephrological diseases, to advance the company’s development pipeline by working closely with program leads and other subject matter experts.
• Author or oversee authorship of relevant sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings including presentation at Advisory Committee Meetings.
• Develop biomarker validation/digital health strategy, analytically validation biomarkers for clinical use, and develop biomarker validation dossiers.
• Design strategy for biomarker/digital asset data collection, ensure optimal execution of preclinical and clinical imaging projects and biomarker assessment, oversee analysis and interpretation of data for various presentations and publications.
• Provide biomarker endpoint/digital health management expertise to internal (Marketing, Sales, Manufacturing, Managed Care, Regulatory Affairs, R&D, and Legal) and external (regulators, healthcare professionals, patients, etc.) customers.
  
  

Education, Registration & Certification

• PhD in relevant discipline
  
  

Experience

• 6+ years of experience in translational drug development.
• Strong understanding of clinical development with experience in both early and late-stage clinical trials.
• Prior experience developing clinical biomarker strategies/digital health assets for drug development candidates.
• Experience representing Translational Medicine/biomarker validation/digital health asset development to Health Agencies to support of regulatory decision making.
• Prior management of CROS for clinical biomarker assay / digital health asset development and validation.
• Prior experience in biomarker data analysis and interpretation.
• Strong leadership, strategic thinking skills, interpersonal skills and ability to build collaborative relationships in a matrixed environment.
  
  

Travel Requirements

• Up to 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.