Senior Medical Director, Immunology
Scientific Jobs is seeking a highly experienced Senior Medical Director to join our client's global pharma organisation. As Senior Medical Director, you will lead and represent the global development team for a portfolio of late-lifecycle Immunology products.
Responsibilities
* Create a positive work environment that enables high-performing teams to thrive.
* Work with direct reports to set performance objectives and create development plans; evaluate performance and provide coaching.
* Serve as a medical expert in late-phase drug development and clinical research.
* Contribute to the identification, prioritization, and assessment of 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, and review regulatory requests and interactions, regulatory submissions, label updates, etc.
* Contribute to the preparation, review, and approval of the 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 that all activities of the medical team comply with current local and international regulations, laws, guidelines (e.g., FDA, ICH, CHMP, etc.), Good Clinical Practices (GCPs), company standards, policies, and procedures, company integrity agreements as applicable, and the Principles of Medical Research.
Requirements
* Medical doctor.
* Physicians must have completed education and training at a medical school that meets the requirements of the US Liaison Committee on Medical Education (LCME).
* US-trained physicians (Medical Doctor or Doctor of Osteopathy) must have achieved board eligibility or certification in Immunology, Internal Medicine, Rheumatology, or Dermatology.
* A minimum of 10 years of work experience in specialties related to Immunology or Internal Medicine.
* Minimum of 3 years of professional experience in pharmaceutical drug development with demonstrated experience and knowledge of clinical research and the drug development process.
* Previous people management experience.
* Strong administrative and leadership skills.
* Fluent in English, written and verbal communications.
* Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.