Senior Medical Director, Immunology

Job Title

Senior Medical Director, Immunology

JR Senior Medical Director, Immunology (Open)

Bridgewater, NJ

Malvern, PA, Philadelphia, PA

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.

• 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.

Education & Experience

• MD (or foreign equivalent) is required;
  Board certification in Immunology (Autoimmunity) preferred.
• Experience in programmatic budget management and strategic resource allocation.
• 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.
• Detailed knowledge of OIG, PhRMA, FDA, EMA, AMA and other relevant guidelines 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,…