Regional Medical Director - United Kingdom
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- Our company is looking for inspirational leaders who understand what it will take to grow and develop a new organization to advance company’s mission of bringing innovative medicines in unmet Liver Disease to patients. Success of our teams will be defined by accelerating broad access to patients for company's innovation. We have an exciting opportunity for a Regional Medical Director to join our International HQ.
- Reporting to the VP, Head of Medical Affairs, International, the Regional Medical Director will have direct leadership responsibilities for Medical Affairs in the UK and Ireland and through country specific Medical Directors, also for the Nordic Region and (planned) in Australia/NZ.
- This person will be responsible for the evolution of Medical Affairs in the Region and so will take the lead for developing and delivering high quality, innovative Medical plans for products in both the late stage development and post-launch phases. The ability to quickly establish excellent knowledge and connections in hepatology and gastroenterology will be critical to help ensure strong customer focused execution
- This is a unique opportunity to play a key role in the growth and success of the company, as both a key member of the local cross-functional Regional Leadership Team and the International Medical Affairs team. There will be strong links into the Global teams in both New York and San Diego.
- As a relatively new company, our people need to develop credible and trusted relationships with key Regional and Country Thought Leaders, including payors and policy makers, and to be passionate about tackling non-viral progressive liver disease.
- It is therefore expected that the Regional Medical Director will spend a considerable amount of time engaging with key external stakeholders.
- Internally, it is critical that this person is committed to building effective cross-functional and cross-regional partnerships.
- This role will demand an ability to work strategically and operationally in equal measures and the right person will thrive in ambiguity and possess an entrepreneurial and innovative spirit. There’s a lot to do – so high energy levels and a sense of humour will be required.
To perform this job successfully an individual must be able to perform each essential function in balance.
- Member of Regional Cross-Functional Leadership Team, responsible for the overall implementation and governance of the Region’s cross functional plans and culture.
- Ensure good business conduct and application of relevant laws, regulations and codes of practice, in spirit as well as by the letter. Responsible for ensuring medical approval for the countries activities and compliance with company Business Conduct requirements.
- Establish the company as a highly credible partner in unmet Liver Disease with our clinical stakeholders in the region:
- External focus will be a critical part of this role.
- Collaborate with academic thought leaders to ensure that the company’s products will serve the clinical needs of patients and to ensure a balanced discussion on their safety and efficacy.
- Plan the evolution of the Medical Affairs department in the countries including attracting, developing and retaining talent to fulfill the mission of company.
- Ensure appropriate training to maintain excellent levels of scientific and medical knowledge.
- Establish a science based culture where we exceed our commitments and under-performance is not tolerated.
- Lead Medical Affairs activities across the Region – aligned to International and Global strategy:
- Work closely with country leadership teams to develop and execute the strategic and operational medical affairs plans for utilizing internal resources and external partners where appropriate
- Member of the International Medical Affairs Leadership Team responsible for establishing the International Medical Plan and ensuring sharing and implementation of best practice.
- Manage the UK & Ireland Medical Affairs Department to ensure alignment of activities within the overall International Medical Plan.
- Excellent fiscal management with a strong focus on building, tracking and monitoring budgets and spend
- Oversee activities in the Nordic Region and Australia/NZ to provide support and ensure alignment with appropriate International and Global plans. Coach and support Country Medical Directors.
- Ensure implementation of Standard Operating Procedures, guidelines, and departmental policies aligned to International and Global.
- Ensure Medical Information is provided utilizing both the Global system and local support.
- Manage early access programs prior to marketing authorization.
- Ensure post marketing commitments, e.g. patient registries, are complied with.
- Develop recommendations for Phase IV and Real World Evidence studies and be the conduit between the clinicians and Clinical Operations for Investigator Sponsored Trials.
- Provide timely and well informed guidance to broader activities, including but not limited to Health Technology Appraisals; business development opportunities.
An MD (or equivalent degree, e.g. MB ChB), ideally with experience in hepatology, either gained through Industry experience or with appropriate postgraduate medical training. The individual will ideally have a higher medical qualification (e.g. MRCP) and accreditation in pharmaceutical medicine (e.g. MFPM, DipPharm Med or equivalent). Clinical and Research experience in the key therapeutic areas is essential.
- Most likely to be an experienced Medical Director within a large European Country – ideally the UK; however, candidates would be considered who have demonstrated exceptional leadership capabilities.
- Prior supervisory/leadership experience essential.
- Demonstrated organizational skills encompassing the successful management of internal and external teams with both direct supervision and in a matrix team environment.
- Deep practical knowledge of Good Clinical Practices and the legal and regulatory requirements of working within a biopharmaceutical company across Europe. UK Code of Practice experience highly desirable
- Entrepreneurial spirit.
- Recent experience in launching new innovations and supporting access for patients.
- Willingness to take the initiative and become directly involved in planning, problem solving and execution of work in a team environment.
- Exceptional interpersonal skills and a collaborative management style.
- Demonstrated problem solving skills – including taking ownership to ensure timely resolution, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables.