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Therapeutic Area Lead
2 months ago
We are seeking a highly skilled Medical Affairs Director to join our team at Precision Hire Solution. As a key member of our organization, you will be responsible for leading the medical and clinical aspects of our business within the assigned therapy area.
Key Responsibilities- Foster the ethical and scientific image of our company as a leading pharmaceutical organization.
- Lead external scientific and clinical exchange with the scientific and medical community, and bring the medical voice of the customer back into the organization.
- Work with the medical team, cross-functional teams, and global teams to provide scientific and clinical expertise advice on our products in the market.
- Provide expert scientific product and disease knowledge and trusted medical leadership to our organization and to our Medical Networks.
- Build and leverage high-quality scientific knowledge and capability expertise.
- Demonstrate leadership and provide guidance for our organization in the assigned therapy area from a scientific perspective.
- Work with different stakeholders to ensure that all relevant planning factors and impacts are assessed in development, pre-launch, launch, and life cycle management strategies within the scope of therapy area responsibility.
- Identify gaps that need Key Evidence Generation studies such as effectiveness studies, health outcome studies, and health economic studies.
- Plan and manage Phase IIIb/IV clinical trials, Collaborative Research Trials (ISS), and Observational studies in accordance with GCP guidelines and company relevant SOPs.
- Identify opportunities to engage our company in R&D studies within the scope of therapy area responsibility.
- Provide the company with relevant clinical data in line with the company's scientific and commercial objectives within guidelines of Good Clinical Practice, local laws, and regulations.
- Lead, develop, and implement a local Medical Strategic Plan for medicines within the assigned therapy area including:
- Identifying areas of research interest and developing timely local study protocols which advance the scientific understanding of our medications.
- Identifying areas of medical education interest.
- Identifying advisory board/1:1 interaction needs and leading their implementation and follow-up.
- Ensuring alignment with commercial strategic planning.
- Managing research budget and budget forecasting processes for assigned products and therapy areas.
- Medical Doctor or Pharmacy Degree.
- Industry Medical Affairs experience is a must.
- Broad range of experiences working in pharmaceutical industry, managed care, academic institutions, hospital setting, or healthcare consulting environment.
- Ability to manage relationships with internal and external partners including Key External Experts, regional and global stakeholders.
- Strong ability to leverage scientific knowledge within the assigned therapeutic area.
- Strong ability to develop timely and meaningful research protocols and study reports.
- Proven leadership skills.
- Demonstrated ability to work as a strategic partner with commercial functions.