Senior Medical Director, Immunology

Mallinckrodt Pharmaceuticals • Malvern, PA

4d

About The Position

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.

Requirements

• 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.
• 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
• 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.

Nice To Haves

• Board certification in Immunology (Autoimmunity) preferred.

Responsibilities

• 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 aera
• 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
• 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.
• Serves as internal point of contact for select, high-level Thought Leaders/Advisors.
• Translates insights from Field Medical personnel into actional recommendations/strategies.
• Participates in strategies and tactics to position clinical value proposition of assigned products to the Payers and Policy communities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree