Our client is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients. The company is looking for a Medical Lead (UK) in BioSimilars to work in a growing team who thrive in an entrepreneurial work environment and enjoy tackling the challenges posed by a new business endeavor. This is a permanent role based in London, UK.
- This Medical Affairs Lead job will involve setting and providing of the strategic direction for the company Medical Affairs and has overall responsibility for the MA activities, including Post marketing studies, Medical educational activities, pharmacovigilance, drug safety and medical compliance for all products within the country/countries.
- Ensures execution of the Medical Affairs strategy and builds and maintains trusted medical/scientific relationships with health care community stakeholders.
- Manages and leads the medical team and is the medical member of the BU management team.
- Provide medical input into regional / global medical strategy leveraging local customer insights
- Lead development of the affiliate medical plan, partnering with the affiliate management team across functions to define, establish and execute a coherent local business plan that addresses patient needs
- Partner and collaborate with market access to show medical value of approved products relevant to local external stakeholders (payers, HCPs, agencies);
- Developing and executing phase IVs, registries, etc. (master real-life medicine)in accordance with the local regulations and the global data generation strategies
- Develop and manage budgets for medical activities and provide input into the affiliate budgeting and planning process
- Support regulatory strategies for registration of new products by providing local expertise
- Build high value-added continuous medical educational programs for external stakeholders
- Coordinate medical review of country-specific promotional materials to ensure scientific accuracy when need external expert coordination strategies within local / regional / global medical team
- Ensure adequate medical training is developed and provided to the affiliate staff
- Encourage medical team to identify lifecycle extension opportunities for product based on patient needs
- Create a climate in which self-motivated individuals will aspire to higher levels of performance by creating high standards, and by rewarding and recognizing exceptional performance
- Create an environment of trust, delegate responsibility to help individuals grow professionally
- Responsible for Compensation Planning/Salary Adjustments (Merit, Promotions, LTI and Pay Adjustments)
- Ensure exchange of medical information with other functions as appropriate for medical affairs and behave as a role model
- Ensure compliance with external laws and internal regulations regarding the appropriate conduct of Affiliate Medical Affairs activities
- Supervise and continuously enhances nctional collaboration where appropriate for MA
Education and Experience:
- Required - Master degree in Pharmacy, MD
- Desired - PhD, PharmD, DNP in medical specialty
- Minimum of 6 years line management experience
- Min 6 years' experience (in larger affiliates 6+ years) within a medical affairs role in:
- Pharmaceutical industry or medical sector (Prior experience in Neurology, Immunology/Dermatology and/or Hematology preferred)
- Knowledge and understanding of disease area, local health care system / market dynamics, regulations, policies and SOPs, health economic techniques and trends
- Broad experience in interaction with health authorities
- Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments
- Demonstrated ability to build a team and develop a high performing organization
- Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job level education
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Russell on +44 203 8246 104 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.