The Medical Director will provide medical and scientific expertise into the planning and execution of medical activities.
Major duties and responsibilities:
Primary Responsibilities:
• Provide clinical input on pathophysiology, diagnosis, existing and emerging treatment options and unmet medical needs to inform key medical and business decisions
• Contribute to and execute the clinical development plan for the products, from early stage of clinical development to preparation and submission of the Registration Dossier
• Develop, or review and approve, clinical protocols, CSR, and other study documents in collaboration with study team members
• Interact with clinical pharmacology, safety, clinical operations, regulatory, device teams and other members of the projects team
• Maintain appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
• Plan and develop content for advisory board meetings with KOLs leaders and medical symposia
• Provide on-going medical expertise, and support to Field Medical Affairs
• Participate to/provide input to the review of scientific publications
• Provide medical support within the company, including developing and delivering training curriculum and content
• Serve as Medical representative on standing and project-based cross-functional teams
Reports To: Senior Medical Director, Clinical Development
Competencies:
Education and Knowledge Requirements:
The Medical Director will have a M.D with work experience in clinical drug development and a minimum 10 years of experience in pharmaceutical industry, including previous experience of interactions with Regulatory Authorities. Previous experience of submission (or at least preparation for submission) of CTD to FDA and/or EMA.
Preferably, previous experience in CNS and in drug-device product.
Must possess:
• Excellent written and oral communication skills, including strong formal presentation skills
• Excellent planning and organization skills
• Strong interpersonal skills
• Ability to maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behavior, and professionalism
• Demonstrated ability to maintain scientific credibility
• High proficiency in problem solving ability and strong scientific analytical skills
• Knowledge of scientific methods, research design and medical practices and procedures
• Ability to travel (frequent travel may be required)
• Strong computer skills (Microsoft Office, etc.) and knowledge of database management
Note: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position may be considered.
Travel Requirements: 20%. International Travel required