VP - EU Head Medical Affairs - Oncology
A life changing opportunity has arisen for a VP to lead EU Medical Affairs in Oncology. This role will give you overall responsibility for European Affiliate with Medical activities including tactics for all products.
As European Head of Medical, you will also support and ensure the vision of maintaining a best-in-class medical function to provide services in alignment with the best governance and performance principles in the best interest of patients, Health Care Providers (HCP), and the company.
- Identifies current and future unmet medical needs, building clinical plans to address relevant questions.
- Plays a leadership role within the Medical Affairs teams, including providing best-practice sharing across countries, therapeutic areas, products etc.;
- Lead, motivate and enhance the performance of the Medical Affairs team through direct reports to achieve agreed objectives;
- Achievement of budget plans;
- Agreed contracts and processes in place with outsource partners;
- Ensures appropriate resource/people to fulfil objectives.
- Leads development of the regional medical plan aligned with global plans, while aligning with the management team, including Access & Reimbursement, Marketing, Sales and Regulatory Affairs, establishes and executes a coherent regional business plan that addresses patient needs; identifies measurable goals to insure execution of medical affairs plan;
- Identifies need for, and lead RWE Projects in close collaboration with cross functional teams and clinics/HCP´s;
- Develops and manages budgets for medical activities and provides input into the medical affairs budgeting and planning process;
- Ensure appropriate training as required to all business/affiliate colleagues on brands and diseases;
- Ensures timely, accurate and appropriate responses to all medical enquiries.
- Acts as a partner for R&D & Clinical Operations for pipeline and new products;
- Supports regulatory strategies for registration of new products by providing local expertise.
- Ensure compliance with external laws and internal regulations regarding the appropriate conduct of Affiliate Medical activities;
- Ensure local medical procedures are in place where necessary;
- Sponsors audits/inspections under Medical Director accountability
Skills and Requirements
- Preferably MD degree with clinical experience;
- PhD is an advantage but not mandatory;
- Preferably course in Pharmaceutical Medicine.
- Knowledge and understanding of local health care system/market dynamics, regulations, policies and SOPs;
- Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments;
- Demonstrated ability to build & lead a team and develop a high performing organization, and experience from leading medical teams and departments;
- Has demonstrated leadership skills and good management and planning skills;
- > 5 years of biotechnology/pharma industry experience;
- Extensive knowledge of all aspects of drug development, GCP and local regulations, including regulations of promotional materials. Familiar with global regulations;
- Experience from Marketing Authorization Application (MAA) processes for new drug application;
- Extensive knowledge of clinical trial design statistics and pharmacokinetics;
- Experience from involvement in reimbursement applications.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.