Overview of Duties and Responsibilities:
- Execute clinical strategy for assigned products
- Represents the company and its therapeutic area products at internal and outside meetings
- Assists senior leadership with assessments and intelligence on potential new products and due diligence activities
- Provides overall scientific and medical oversight within the therapeutic area for marketed and developmental projects
- Provides medical support for clinical operations groups on assigned projects
- Serves as a link between groups
- Work with the commercial team to help build awareness of the company’s products in the medical community, including running company sponsored Advisory Boards, participating in medical symposia, publication, media events, and other activities
- Help direct and guide clinical commercial development by working on protocol design, investigator selection, investigator driven trial monitoring, data management, analysis, promotional review and communication of results
- Help identify, develop, and maintain partnering relationships with current and future thought leaders.
- Collaborate with thought leaders to develop potential clinical therapeutic ideas that will support the company vision.
- Help develop concepts for investigator initiated non-registration studies and provide scientific and clinical insight in support of the study process
- Drive internal and external communication strategies for disease information and clinical messaging
- Provide medical support for pharmacoeconomic/outcome research studies
- Provide clinical support for field sales efforts and medical science liaisons to help them provide the scientific and clinical information necessary in order to improve patient care
- Provide support for speaker development
- Assist with the clinical training of internal customers as needed
- Provide scientific and clinical insight in the Investigator Initiated Study process
- Participate in the evaluation/negotiation of in-licensing, joint ventures and corporate partnerships as appropriate.
- Manage Drug Safety Assessments and Surveillance within Clinical Programs
- Provides scientific and medical oversight of projects.
- Provides input for clinical studies and works with the project teams to design and conduct clinical studies.
- Develops scientifically rigorous publications plan, posters and presentations for promulgation in journals and at scientific meetings.
Overview of basic Qualifications:
- MD or equivalent, PharmD possible
- Industry experience in either clinical development or medical affairs
- Board Certification or equivalent in a medical specialty a plus
- Training and/or experience in Neuroscience a plus
- Clinical practice experience a plus