Vice President, Medical Affairs in San Diego, CA

$$250K+(Ladders Estimates)

ACADIA Pharmaceuticals   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 61 days ago

This job is no longer available.

Provides strategic and medical oversight for marketed products as well as input into projects under late phase of development. Responsible for the medical science liaison group as well as relationships with key opinion leaders (KOLs) and other members of the science/medical community.

Primary Responsibilities

  • Provides strategic leadership and direction to the team within Medical Affairs including Medical Information and Communication, Medical Science Liaisons, Publications, and Medical Education.Assists with post-marketing pharmacovigilance processes in accordance with standard operating procedures for adverse event and general safety reporting consistent with FDA regulations.
  • Provides broad scientific/medical support for late stage(IIIb/IV) clinical development programs.
  • Develops and implements strategies for life cycle management of commercial products, including post-marketing clinical studies, with Marketing and Business Development
  • Develops and manages relationships with Key Opinion Leaders (KOLs).
  • Actively participates/leads and supports company clinical and marketing advisory boards and participates in local/regional/national research symposia upon request.
  • Leads the Company's review and assessment of investigator-initiated study proposals.
  • Represents Medical Affairs for review of promotional materials.
  • Assists publication activities, including the development of abstracts and manuscripts in collaboration with Marketing.
  • Oversees management of funding for medical education grants to ensure that funds are allocated appropriately, and that review and approval processes are in place to maintain strict compliance with all federal regulations in the US
  • Represents the company with managed care organizations, advocacy groups, reimbursement leaders, and policymakers by addressing the scientific and medical/health aspects of the company's product portfolio.
  • May provide medical/clinical/scientific information and expertise to all internal departments, including marketing, sales training, commercial, business development, regulatory, manufacturing, and investor relations.
  • Directs and oversees the activities of the U.S. medical science liaison group.
  • Develops relationships with the medical/scientific community including physicians and medical centers, by communicating product-related information.
  • Determines resource needs for the function, and manages Medical Affairs to ensure company goals are met.
  • Works with QA to develops and implement relevant SOPs.
  • Performs all duties in keeping with the Company's core values, policies and all applicable regulations.
  • Cultivates a high-performing team through the creation of a practical vision, specific goals and concrete metrics to achieve success, meeting changing business demands and delivering consistent results in challenging environments.
  • Develops and mentors team members to support individual and team success.
  • Serves as a representative of the organization to both internal and external groups and ensures information communicated is accurate and up to date.
  • Ensures department's adherence to company policies as well as other legal and regulatory directives.

Education/Experience/Skills

  • MD or Pharm D with a substantial number of years of progressively responsible and related experience within the pharmaceutical industry; a minimum of 10 years in a leadership role. Neurology experience required.
  • Successful track record of leading a medical affairs department.
  • Knowledge of the regulatory framework for approval and post-marketing commercial activities (FDA, DDMAC).
  • Experience with literature information databases.
  • Strong verbal and written communication skills at a professional medical level.
  • Management and supervisory experience including experience with contractors and medical information service providers.
  • Leadership, coaching and mentoring skills.
  • Ability to manage budgets, multiple projects, and timelines.
  • Ability to collaborate cross-functionally across teams and across the organization (clinical, development, commercial).
  • US pharmaceutical experience from pre-launch through commercial/development lifecycle.
  • Experience of supporting product launches.
  • Publication and manuscript preparation experience.
  • Full understanding of all stages of pharmaceutical drug development process.
  • Skilled at effectively consolidating and communicating information from diverse sources through all levels of the organization, up to executive management across all functional areas.
  • Adept at linking the team vision to corporate goals, strategy, and objectives and fostering a common vision within and between teams. Proficient at effectively aligning resources and activities to achieve organizational goals


Valid Through: 2019-9-16