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Vice President of Global Safety Operations

2 months ago

Waltham, Massachusetts, United States Apellis Full time
Job Overview

Position Summary:

The Vice President of Global Drug Safety and Pharmacovigilance serves as a pivotal safety physician and a prominent leader within the Global Development Organization. This role is essential for managing safety and pharmacovigilance across all active clinical trials, anticipated global product launches, and post-marketing initiatives. This position commands high visibility and requires interaction across various management levels and functional domains, offering safety leadership and guidance on numerous organizational initiatives.

Key Responsibilities:

  • Direct a diverse, global team tasked with executing and monitoring comprehensive safety and pharmacovigilance strategies for products throughout all phases of development and commercialization.
  • Establish strategic Drug Safety and Pharmacovigilance plans and protocols.
  • Oversee product safety surveillance strategies and manage the evolving safety profiles for clinical development programs and marketed products.
  • Lead the cross-functional product safety team, ensuring timely communication of safety concerns to senior management as necessary.
  • Expand, guide, and enhance the operations of a global function supporting products from Phase 3 through NDA/MAA submissions to approval and post-marketing activities.
  • Conduct routine pharmacovigilance tasks for assigned programs, including the creation of Reference Safety Information, aggregate safety reporting, signal detection, and literature analysis.
  • Develop and update safety/risk sections in clinical protocols, investigator brochures, and informed consent documents.
  • Formulate analysis strategies for the Integrated Summary of Safety (ISS) and benefit-risk content within Clinical Overview documents associated with regulatory submissions.
  • Coordinate the design, development, and execution of Risk Evaluation and Mitigation Strategies (REMS) involving multiple stakeholders.
  • Advise on the design of post-approval safety studies.
  • Facilitate interdepartmental collaboration to ensure adherence to safety standards and effective communication.
  • Oversee the medical-safety components of aggregate safety reports (DSUR, PSUR).
  • Support the successful implementation, execution, and maintenance of safety processes and systems that align with the company’s strategic objectives, industry standards, and global regulations.
  • Provide medical safety expertise for monitoring clinical trials and data safety monitoring boards.

Qualifications:

  • MD or relevant advanced degree in health sciences with applicable experience.

Experience:

  • Over 10 years of experience in pharmacovigilance and drug safety.
  • In-depth knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidelines related to pharmacovigilance and Good Clinical Practices, as well as familiarity with the Code of Federal Regulations regarding drug safety.
  • Proven leadership experience with a strong record of providing clear direction, removing obstacles, and developing talent.
  • Ability to review, synthesize, analyze, and communicate complex safety data and clinical/pharmaceutical information effectively.

Skills, Knowledge & Abilities:

  • Capability to design, lead, and manage a geographically dispersed, multi-functional organization effectively.
  • Exceptional interpersonal skills, with demonstrated ability to work in a multi-disciplinary environment, promote teamwork, and act as a facilitator to achieve corporate strategic goals.
  • Outstanding written and verbal communication skills, with the ability to collaborate and build relationships with colleagues at various organizational levels.
  • Highly motivated and adaptable in a fast-paced work environment.

Travel Requirement:

  • Willingness to travel up to 25% as needed.

Benefits and Perks:

Apellis offers a comprehensive benefits package that includes health insurance with full premium coverage, a 401K plan with company matching, paid time off (PTO), long-term disability insurance, life insurance, and more.

Company Overview:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical organization that merges innovative science with compassion to develop transformative therapies for some of the most challenging diseases faced by patients. We introduced the first new class of complement medicine in 15 years and currently have two approved therapies targeting C3, including the first and only treatment for geographic atrophy, a leading cause of blindness worldwide. With numerous clinical and pre-clinical programs in progress, we believe we are just beginning to unlock the potential of targeting C3 across various serious diseases.

EEO Statement:

Apellis is an equal opportunity employer and adheres to all applicable federal, state, and local fair employment practices laws. We strictly prohibit discrimination against employees, applicants, or any other covered individuals based on race, color, religion, creed, national origin, ethnicity, sex (including pregnancy), gender identity, age, physical or mental disability, citizenship, military service, genetic information, marital status, and other protected characteristics.

Other Duties:

Please note that this job description is not intended to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this position. Duties, responsibilities, and activities may change at any time with or without notice.