Senior Medical Director, Immunology

Job Description

The Medical Director is responsible for the planning and execution of product-specific scientific/medical strategic and tactical plans for a single TA, multiple products or indications. This role is considered the medical/scientific subject matter expert for these assets. The Medical Director also serves as the primary internal R&D contact for external advisors in assigned therapeutic areas.

Key Accountabilities

• R&D Point of Contact:
  • Responsible for Life Cycle Management Plan development and implementation.
    • Identification of product-specific, strategic scientific platforms.
    • Creation of tactical plans that support strategic platforms.
    • Represents Medical Affairs on the Brand Team.
    • Drives annual and strategic medical affairs plan for assigned asset/therapeutic area.
    • Provides Medical Affairs input into the development of later stage Clinical Study Programs for assets within therapeutic area.
    • Develops and executes the TA phase IV plan and is directly responsible for protocol development, analysis plan, study execution, data read out and interpretation.
    • Co-chairs post approval product-specific R&D Project Teams for assigned products.
    • Provides input into business development opportunities.
    • Provides scientific and strategic input into key Medical Affairs deliverables including scientific platform, publications strategy, medical education strategy, Investigator Initiated Research strategy.
  • Commercial Point of Contact:
    • Serves as medical/scientific subject matter expert for assigned products and therapeutic areas.
    • Works collaboratively with Business Unit heads and Marketing Directors to ensure coordination and consistency of medical platforms with commercial strategies.
    • Participates in product- and therapeutic area-specific education of internal stakeholders.
  • Field Medical Point of Contact:
    • Serves as internal point of contact for select, high-level Thought Leaders/Advisors.
    • Translates insights from Field Medical personnel into actionable recommendations/strategies.
    • Participates in strategies and tactics to position clinical value proposition of assigned products to the Payers and Policy communities.

  Qualifications

  • Education & Experience:
    • MD (or foreign equivalent) is required; Board certification in Immunology (Autoimmunity) preferred.
    • A minimum of 10 years of experience in developing and implementing R&D strategic direction for marketed and soon to be marketed assets.
    • Hands-on experience in the creation and implementation of pharmaceutical Life Cycle Management programs.
    • Experience and capability and a track record in conducting phase IV clinical research.
    • Demonstrated experience in scientific publication planning and implementation.
  • Knowledge:
    • Expert knowledge of late-stage pharmaceutical development including global regulatory requirements.
    • Strong knowledge of the pharmaceutical/healthcare market, acceptable practices and related regulations is required.
    • Advanced understanding of clinical/medical science is required.
  • Skills & Abilities:
    • Demonstrated ability and experience working cross-functionally, as well as influencing and negotiating at all levels within the organization.
    • Demonstrated ability to anticipate, organize, plan and handle multiple changing priorities.
    • Demonstrated ability to work independently while adhering to Medical Affairs’ strategic direction.
    • Demonstrated proficiency in communicating upward, downward and laterally, verbally and in writing.
    • Demonstrated ability to analyze complex situations and proactively identify opportunities/issues; and effectively solve problems that cross functional boundaries.
    • Demonstrated ability to manage out-sourced projects including vendor/agency management.
    • Committed to the concept of team and working within the framework of the Medical Affairs Department and Endo organization, including as it pertains to compliance with policies, systems and practices.
    • Demonstrated ability to work with software tracking/logging systems.

  Physical Requirements

  This is a headquarters-based position that will require moderate travel (approximately 20-30% of time).

  Benefits

  Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

  Pay

  The expected base pay range for this position is $215K - $280K. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.

  Schedule

  This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.