Medical Director – Migraine & Cluster Headache – Amneal Pharmaceuticals, Inc. – Bridgewater, NJ

Description:

We are seeking a Medical Director, Migraine and Cluster Headaches, to join our US Medical Affairs team at Amneal Pharmaceuticals, Inc. The role serves as the internal scientific expert supporting the designated Therapeutic area or product within the Specialty Medical Affairs business unit. Reporting to the Vice President, Medical Affairs, this role is responsible for providing strategic leadership and direction in developing and executing Medical Affairs plans for the Migraine and Cluster Headaches therapeutic area. The Medical Director will collaborate closely with cross functional teams to ensure alignment with business objectives and regulatory compliance.

This position will also provide clear and consistent medical and scientific inputs throughout the late-stage development and commercialization phases for all related products/services in the area of expertise.

Responsibilities:

• The Medical Director will play a pivotal role in developing and executing the medical affairs plan, which encompasses post-marketing research, medical education, medical advisory boards, and scientific communication/publication components.
• The Medical Director provides strategic development, planning, implementation and oversight of clinical trial programs within the Medical Affairs department for products in the therapeutic area.
• The Medical Director utilizes expert medical/scientific knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit feedback and strengthen Amneal’s medical reputation in the disease state community.

This role works with the Clinical Development, Clinical Operations, Regulatory Affairs, Program Management, and teams.• Interfaces with both internal and external stakeholders including Key Opinion Leaders (KOLs) and Principal Investigators.

Essential Functions:

• US Medical Affairs Strategic Leadership: Collaborate with key internal US and Global stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans for the Migraine and Cluster Headaches therapeutic area. Communicate and represent these plans to upper management/senior leadership within Amneal. Continuously update plans and inform stakeholders of progress.
• Medical/Scientific Subject Matter Expert: Act as Medical Leader and Subject Matter Expert providing direction for assigned products including scientific communications, publication planning/review, advisory boards, MSL activities, speaker programs, investigator-initiated research and CME grant reviews or other internal key business processes.
• Clinical Trial Oversight: Direct and design strategies, planning and implementation of clinical development programs for assigned products. Provide medical oversight for protocol development, interpretation of trial results, final study report conclusions and publications.
• External leadership: Provides leadership and strategic direction to internal stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. Maintains external orientation by participating actively in external events and activities.

Education:

• Medical Doctor Degree Board Certified in Neurology and US Fellowship training in Headache Medicine with Certification – Required

Experience:

• 5 years or more in 5 – 7 years practicing Headache Medicine

Skills:

• Science- and data-driven, analytical mindset with the ability to convey scientific and clinical vision effectively – Advanced
• Proficiency with remote collaboration tools such as MS Teams, SharePoint, OneDrive, and other Office 365 applications – Advanced
• Familiarity with statistical methodology preferred – Intermediate
• Excellent written and oral communication skills – Advanced
• Ability to work independently to resolve challenges and conflicts. – Advanced

Specialized Knowledge:

• Knowledge of the pharmaceutical marketplace. Industry experience in the field of Headache Medicine preferred
• Experience in conducting Phase III-IV clinical trials preferred.
• Familiarity with FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.