Senior Medical Director Oncology and Diabetes
Our client, a global pharma organisation, is recruiting for a Senior Medical Director to lead a new team within the organisation. The successful candidate will be responsible for representing the global development team for a portfolio of late-lifecycle oncology and diabetes products.
Responsibilities:
* Lead high-performing teams by creating a positive work environment.
* Work with direct reports to set performance objectives, create development plans, evaluate performance, and provide coaching.
* Serve as a medical expert in late-phase drug development and clinical research.
* Contribute to identifying, prioritising, and assessing collaboration opportunities.
* Lead the conduct and reporting of global clinical trials to support regulatory interactions, registration, and delivery of innovative treatments.
* Review and approve protocols, study reports, data dissemination, and disclosures.
* Contribute to strategy development and execution of the product scientific data disclosure plan, including manuscript and congress preparation and review.
* Represent the team in Periodic Safety reviews and ad-hoc safety topic reports as required.
* Plan, respond to, and review regulatory requests and interactions, regulatory submissions, label updates, etc.
* Contribute to preparing, reviewing, and approving product Investigator Brochures (IB), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Profile, and any other right-to-operate documents as required.
* Interact and build relationships with external parties, including collaborators, investigators, clinicians, and thought leaders.
* Ensure all activities of the medical team comply with current local and international regulations, laws, guidance, Good Clinical Practices (GCPs), company standards, policies, and procedures, integrity agreements as applicable, and the Principles of Medical Research.
Requirements:
* Medical doctor degree.
* Completed education and training at a medical school that meets the requirements of the US Liaison Committee on Medical Education (LCME).
* US-trained physicians must have achieved board eligibility or certification in Oncology, Hematology, Diabetes, or Internal medicine.
* A minimum of 10 years' experience in specialties related to Immunology or Internal medicine.
* Minimum of 3 years' professional experience in pharmaceutical drug development, demonstrating knowledge of clinical research and the drug development process.
* Previous people management experience.
* Strong administrative and leadership skills.
* Fluent English language communication skills.
* Ability to engage in occasional domestic and international travel.