We are currently searching for a skilled professional to join a well-known client’s team as a remote Senior Director Medical Affairs. The Senior Director of Medical Affairs will serve as the lead for the US Medical Affairs team and is responsible for developing and executing the US Medical Affairs strategy. This individual also collaborates closely with the Global business unit (BU) and the regional marketing organization to identify US nutrition insights and clinical nutrition opportunities to help advance the business. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Work with the Global and US regulatory & commercial team to support pipeline advancement, on-market strategy/execution and FDA approval and post marketing commitments for parenteral nutrition (PN) products, providing medical / scientific support.
• Mentor, manage, and ensure development of the PN Medical Affairs Team.
• Lead team to support medical content development and review of all parenteral nutrition communication tools including marketing/promotional tools (MRL), medical/clinical inquiries, and scientific dossiers to support safe and appropriate product use.
• Lead field (MSLs) and HQ team to ensure complaint and effective healthcare professional interaction and communication of appropriate and safe product use.
• Support US clinical nutrition post marketing commitments including clinical study protocol development and review, study execution, and study report development. Evaluate IIT support requests per medical strategy alignment and scientific merit.
• Lead field and HQ team to manage strategy, develop targets, and process for US Key Opinion Leader and HCP scientific exchange in PN.
• Create and manage Medical Education program to support internal and external training needs for PN.
• US Medical Affairs Parenteral Nutrition representative to Global Medical Committee.

EXPERIENCE

• 12+ years of related experience required (clinical and/or industry experience; expertise in PN and/or EN highly preferred).
• 5+ years pharmaceutical industry experience required.
• 5+ years of Medical Affairs experience required.
• 7+ years of management experience and demonstrated leadership.
• Experience leading field teams (e.g., MSLs) strongly preferred.
• Demonstrated skill in writing scientific documents.
• Knowledge of clinical trial design and process.
• Knowledge of applicable regulatory, legal and compliance standards.
• Position will require 30% travel, including overnight stays.
• Strong communication skills, both written and verbal.
• Demonstrated ability to work cross functionally.

EDUCATION:

MD, RD, RPh, PhD, PharmD, or RN degree required.