Vice President of Global Safety Operations

1 week ago

Waltham, Massachusetts, United States Apellis Full time
Position Overview

Role 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 position is responsible for the comprehensive oversight of safety and pharmacovigilance across all active clinical trials, anticipated global product launches, and post-marketing initiatives. This role is highly visible and requires interaction across various management levels and functional areas, providing essential safety leadership and guidance on numerous organizational initiatives.

Key Responsibilities:

  • Direct a diverse, global team tasked with executing and monitoring all safety and pharmacovigilance strategies for products at every stage of development and commercialization.
  • Establish strategic Drug Safety and Pharmacovigilance plans and policies.
  • Oversee product safety surveillance strategies and manage the evolving safety profiles for clinical development programs and post-marketed products.
  • Lead the cross-functional product safety team, ensuring effective communication of safety issues to senior leadership 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.
  • Conduct routine pharmacovigilance activities for assigned programs, including the development of Reference Safety Information, aggregate safety reporting, signal detection, and literature reviews.
  • Draft and update the safety/risk sections in 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 related to regulatory submissions.
  • Coordinate the design, development, and implementation of Risk Evaluation and Mitigation Strategies (REMS) among various stakeholders.
  • Advise on the design of post-approval safety studies.
  • Facilitate cross-functional collaboration within the organization to ensure adherence to safety standards.
  • Oversee the medical-safety sections of aggregate safety reports (DSUR, PSUR).
  • Support the successful implementation, execution, and maintenance of safety processes and systems that align with the company’s business strategy, industry standards, and global regulations.
  • Provide medical safety expertise for monitoring clinical trials and data safety monitoring boards.

Qualifications:

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

Experience Required:

  • 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, along with a solid understanding of the Code of Federal Regulations concerning 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 and Competencies:

  • Capability to design, lead, and manage a geographically dispersed, multi-functional organization effectively.
  • Exceptional interpersonal skills, with a demonstrated ability to work in a multi-disciplinary environment, foster teamwork, and facilitate the achievement of 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 with the flexibility to thrive in a fast-paced environment.

Travel Expectations:

  • Up to 25% travel may be required.

Benefits Overview:

Apellis offers a comprehensive benefits package, including 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 company dedicated to combining 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 are committed to unlocking the potential of targeting C3 across various serious diseases.

Equal Employment Opportunity:

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, gender, age, disability, citizenship, and other protected characteristics.

Additional Information:

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.

  • Vice President of Global Safety Operations

    1 week ago

    Waltham, Massachusetts, United States Apellis Full time

    Job OverviewPosition 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 overseeing safety and pharmacovigilance across all active clinical trials, anticipated global product launches, and post-marketing...

  • Vice President of Global Safety Operations

    2 weeks ago

    Waltham, Massachusetts, United States Apellis Full time

    Job OverviewPosition 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...

  • Vice President of Development and Construction

    7 days ago

    Waltham, Massachusetts, United States Global Partners Full time

    About the RoleWe are seeking a highly skilled and experienced professional to join our team as a Vice President of Development and Construction. This is a critical role that will play a key part in driving the growth and success of our Real Estate team.Key ResponsibilitiesManage all aspects of permitting, procurement, and construction for new travel center...

  • Senior Vice President of Legal Affairs

    2 weeks ago

    Waltham, Massachusetts, United States Global Partners Full time

    Position Overview:The Senior Vice President of Legal Affairs will play a pivotal role in shaping both short-term and long-term strategies that influence the legal operations of the organization. This position will act as the principal in-house legal advisor for the Human Resources and Information Technology departments, while also providing support to...

  • Vice President of Investment Strategies

    2 weeks ago

    Waltham, Massachusetts, United States Benchmark Senior Living Full time

    Company Overview:Benchmark Senior Living, established in 1997, is recognized as the premier provider of senior housing solutions in New England. With headquarters in Waltham, MA, the organization is dedicated to delivering exceptional services and care, embodying the comfort and warmth of home. Benchmark excels in various service areas, including independent...

  • Senior Vice President of Regulatory Affairs

    1 week ago

    Waltham, Massachusetts, United States Meet Full time

    Senior Vice President of Regulatory Affairs*Candidates should be located in New England or must be open to travel*Primary ResponsibilitiesProvide strategic oversight and regulatory guidance to the Regulatory Affairs, Clinical Quality, and Medical Writing teams while leading the Regulatory Affairs division, including recruitment, mentorship, and team...

  • Senior Vice President of Product Strategy

    1 week ago

    Waltham, Massachusetts, United States Wolters Kluwer Full time

    The Senior Vice President of Product Management for Banking Compliance Solutions (BCS) plays a pivotal role within the BCS division of Wolters Kluwer Compliance Solutions. This leadership position is accountable for steering the product strategy and innovation execution, overseeing product development, and enhancing customer engagement with technology...

  • Investment Associate or Vice President

    2 weeks ago

    Waltham, Massachusetts, United States Windjammer Management Full time

    Windjammer Capital is seeking an Investment Associate or Vice President to become a vital member of their investment team, engaging in diverse activities such as sourcing, assessment, due diligence, and execution of investment opportunities. The selected candidate will collaborate closely with the deal team leader and will hold significant responsibilities...

  • Vice President of Engineering Leadership

    1 week ago

    Waltham, Massachusetts, United States InnoTech Staffing Full time

    Job OverviewInnoTECH Staffing is seeking a Vice President of Hardware Engineering and Program Management for a pioneering company in the in-vitro diagnostics sector.The organization is evolving from research and development to market introduction and requires a seasoned leader in Hardware Engineering with a robust background in product development from...

  • Senior Vice President of Product Strategy

    1 week ago

    Waltham, Massachusetts, United States Wolters Kluwer Full time

    The Senior Vice President of Product Management for Banking Compliance Solutions (BCS) plays a pivotal role within the BCS Segment of Wolters Kluwer Compliance Solutions. This position is responsible for steering the product strategy and innovation execution, overseeing product development, and enhancing customer engagement with technology solutions that...

  • Senior Vice President of Product Strategy

    1 week ago

    Waltham, Massachusetts, United States Wolters Kluwer Full time

    The Senior Vice President of Product Management for Banking Compliance Solutions (BCS) plays a pivotal role within the BCS Segment of Wolters Kluwer Compliance Solutions. This position is responsible for steering the product strategy and innovation execution, overseeing product development, and enhancing customer engagement with technology solutions that...

  • Senior Vice President of Product Strategy

    2 weeks ago

    Waltham, Massachusetts, United States Wolters Kluwer Full time

    The Senior Vice President of Product Management for Banking Compliance Solutions (BCS) plays a pivotal role within the BCS Segment of Wolters Kluwer Compliance Solutions. This leadership position is essential for steering the product strategy and execution of innovative solutions, overseeing product development, and enhancing customer engagement with...

  • Senior Vice President of Product Strategy

    2 weeks ago

    Waltham, Massachusetts, United States Wolters Kluwer Full time

    The Senior Vice President of Product Management for Banking Compliance Solutions (BCS) plays a pivotal role within the BCS Segment of Wolters Kluwer Compliance Solutions. This position is responsible for steering the strategic direction and innovative execution of Expert Solution products, focusing on product development and enhancing customer engagement...

  • Senior Vice President of Product Strategy

    2 weeks ago

    Waltham, Massachusetts, United States Wolters Kluwer Full time

    The Senior Vice President of Product Management for Banking Compliance Solutions (BCS) plays a pivotal role within the BCS Segment of Wolters Kluwer Compliance Solutions. This leadership position is responsible for steering the product strategy and innovation execution for Expert Solutions, focusing on product development and enhancing customer engagement...

  • Vice President of Engineering Leadership

    2 weeks ago

    Waltham, Massachusetts, United States InnoTech Staffing Full time

    Job OverviewInnoTECH Staffing is seeking a Vice President of Hardware Engineering and Program Management for a pioneering in-vitro diagnostics organization.The firm is evolving from research and development to market introduction and requires a seasoned leader in Hardware Engineering with expertise in product innovation from inception to market launch. The...

  • Investment Vice President

    7 days ago

    Waltham, Massachusetts, United States Windjammer Management Full time

    Job DescriptionWindjammer Management is seeking an experienced Senior Investment Associate or Investment Vice President to join their investment team. The successful candidate will participate in the sourcing, evaluation, diligence, and execution of investments, investment execution, and portfolio management of portfolio companies, and sourcing of new...

  • Vice President of Engineering Leadership

    2 weeks ago

    Waltham, Massachusetts, United States InnoTech Staffing Full time

    Job OverviewInnoTECH Staffing is seeking a Vice President of Hardware Engineering and Program Management for a pioneering company in the field of in-vitro diagnostics.The organization is evolving from research and development to market introduction and requires a seasoned leader in Hardware Engineering with extensive experience in product development from...

  • Vice President of Strategic Partnerships

    1 week ago

    Waltham, Massachusetts, United States Buyers Edge Platform Full time

    About Us:At Buyers Edge Platform, we are pioneering advancements in the foodservice sector through innovative technology, enhanced purchasing capabilities, and strategic alliances. Our goal is to empower all participants in the foodservice ecosystem—operators, distributors, and manufacturers—by providing unparalleled efficiency and visibility.With a...

  • Senior Vice President, Clinical Operations and Strategic Innovation

    2 weeks ago

    Waltham, Massachusetts, United States Miltenyi Biotec Full time

    Are you prepared to engage in the personalized medicine evolution? Miltenyi Biomedicine, a pioneering division of the Miltenyi Biotec family, is dedicated to delivering tailored cancer therapies and regenerative treatments to patients globally. Our organization plays a vital role in bridging the gap between laboratory research and patient care, ensuring that...

  • Associate Director, Global Facilities and Operations

    4 days ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job SummaryWe are seeking an experienced Associate Director to lead our Global Facilities and EHS team at Deciphera Pharmaceuticals. This role will be responsible for overseeing the daily operations and maintenance of our facilities, ensuring a safe and healthy work environment for our employees and visitors.Key ResponsibilitiesOversee the management of...