Job Description
The Executive Medical Director, Regional Medical Affairs will be based in Munich, Germany and plays a pivotal leadership role in shaping and advancing the vision for the Medical Affairs organization across the designated region. This individual is charged with developing and executing comprehensive Medical Affairs strategy and programs that facilitate successful product launches within the designated therapeutic area and region.
A key aspect of the role is the close collaboration with cross-functional leadership teams to ensure that the unique needs and priorities of the regions are effectively integrated into a unified Global Medical Affairs strategy. This collaborative approach ensures alignment and maximizes impact at both the regional and global levels.
Additionally, the Executive Medical Director works in partnership with the cross-functional teams, including Commercial, Market Access, GAPP, Corporate Communications, Legal, Compliance (OBIE),Regulatory, Global Medical, Research & Development, HR Business Partners, and Finance. Through these partnerships, the leader drives cross-functional alignment, anticipates future organizational needs, and makes meaningful contributions to the long-term success of both the region and Vertex as a whole.
Key Duties and Responsibilities:
- Provides a governance framework and oversight of Medical Affairs activities across the designated region, providing strategic input and guidance to the Country Medical Directors and/or country colleagues
- Accountable for development and execution of designated region and disease area medical plan in accordance with corporate policies and procedures and applicable local laws, regulations and code of practice
- Align medical strategy with organizational goals by ensuring own and team responsibilities and goals are aligned with the long-term aims of the organisation and other departments.
- Leads the strategic regional input and forward-thinking medical insight into development of Lifecycle Management (LCM) plans ensuring that all the data generation activities demonstrate coherent strategy, and are aligned according to designated region evidence gaps and Global Medical Affairs Strategy
- Drive data generation studies/projects to enhance medical-scientific knowledge in the Therapeutic Area(s) and ensure implementation of RWD initiatives and LCM plans in the region, as appropriate
- Accountable for supporting the Regional Medical Leads in the development, implementation and execution of the Regional Medical Strategy and plan for pipeline therapies
- Establishes and tracks medical KPIs that demonstrate impact on business and patient outcomes.
- Uses scenario planning and market foresight to prepare for multiple potential realities, adapting strategies and plans to respond to evolving internal and external environments.
- Applies structured problem-solving and root cause analysis to identify solutions that maximize medical and business impact
- Develop and maintain high level, clinical and scientific knowledge designated therapy area and good knowledge of all Vertex therapeutic areas.
- Provide strong leadership inspiring and empowering a dedicated medical team and promoting a culture of continuous development.
- Accountable for the recruitment, development, management and coaching the regional HQ medical team
- Leverages the capabilities and expertise of the team to ensure successful execution of medical plans
- Identifies and addresses team skill gaps, considering how to accelerate internal talent or attract external to meet needs of a future-ready organization.
- Adheres to formal goal-setting, talent and performance cycles ensuring individual development plans (IDPs) are in place
- Navigates ambiguous or rapidly evolving situations, and coach the team during periods of uncertainty or change.
- Responsible to build and maintain excellent working partnerships with Health Care Professionals (HCPs) based on scientific excellence and trust
- Partner with HCPs to provide and obtain insights on therapeutic area issues and questions
- Develop and execute at regional and support country level, advisory, collaborative and/or educational activities aligned to the Vertex strategy
- Contribute to transparent and successful partnerships with national scientific societies, patient organizations, relevant payers, policymakers and relevant industry associations
- Provide fair and balanced medical information and education to health care professionals and HTA/payer stakeholders that support the safe and effective use of Vertex’ medicines in the appropriate patients
- Deliver external presentations (advisory board meetings, symposia, other medical education meetings) to enhance the medical knowledge of pipeline and marketed products, as required and in accordance with local regulations and procedures
- Tailors communications to stakeholder needs, building trust and understanding across diverse audiences.
- Ensure adequate internal training is provided to medical and XFT, contribute individually as appropriate
- Leads medical input and works in partnership with the Commercial leaders as well as other cross functional team (XFT) colleagues to ensure that the appropriate patients have fair access in a safe and effective manner, support development and implementation of the designated region cross functional plans aligned with patient, HCPs’ and broader corporate needs
- Ensure high level of support and contribution to access efforts through the preparation/review of reimbursement dossiers, scientific engagement of key stakeholders, presentation of scientific data as required to key stakeholders in the access process
- Incorporation of medical insights into strategy, perform data gap analysis relevant to access and support locally needed data generation as appropriate
- Lead accountability for reviewing and certification of promotional and non-promotional materials in the respective area according to the company SOP and to local country and regional regulations
- Keep up to date with pipeline information based on internal and external publications and business presentations
- Ensure compliance of medical activities in accordance with Vertex Code of Conduct, rules and regulations, company policies, SOPs, GCP and ICH
- Assess region/local promotional materials and ensure that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner
- Ensure self and other regional medical staff have the required skills to identify and report AEs appropriately
- Responsible for managing external communication in collaboration with global medical, clinical and other XF colleagues when significant safety issues arise, with the wellbeing of patients being the ultimate goal
- Co-leads cross-functional teams to ensure operations are patient-focused, including rapidly responding to internal and external requests and provide strategic medical affairs input and guidance to key stakeholders
- Provide strategic medical and scientific input into XF team activities, for example access, media, government and patient group activities, including policy development, corporate initiatives and issues management
- Ensure governance and maintain a seamless flow of information within and between the local structure and designated region Medical Affairs, and communicate medical insights obtained locally from appropriate field interactions to inform local, regional and global strategy/tactics
- Accountable for strategic input into the development of the broader aims of the regional organization such as regional designated disease area strategy & plans, policy development, financial planning, budgeting
- Work in strategic partnership with Regulatory, Pharmacovigilance, Medical Information, Clinical Development, Global Clinical Operations and Health Economics Outcomes Research teams in medical scientific questions
- Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals
- Considers the downstream impact of medical decisions on countries, other functions, and stakeholders
- Facilitate appropriate and adequate implementation of compassionate use programs in region
- Ensure sourcing accurate epidemiology data in collaboration with local registries/other stakeholders, as applicable
- Ensure medical team supports Investigator Initiated research aligned with strategic areas of interest and in a compliant manner as applicable
Knowledge and Skills:
- Apply sound business judgment, understanding the financial and strategic impact of decisions.
- Exhibit exceptional scientific expertise and disease area knowledge.
- Maintain advanced knowledge of industry, regulatory, clinical, and scientific standards.
- Demonstrate strong technical and ethical judgment in all responsibilities.
- Uphold corporate objectives with the highest ethical and scientific standards.
- Foster cross-functional collaboration, teamwork, and a patient-focused mindset.
- Lead and develop teams in a matrixed environment.
- Influence effectively with senior leaders and stakeholders.
- Have deep Medical Affairs expertise, including global (US and ex-US) regulatory and compliance knowledge
- Travel up to 30% required.
Education and Experience:
- Medical Degree and/or a higher degree or PhD in life sciences
- Extensive leadership/management experience in Medical Affairs within Pharma/ Biotech space.
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com