Senior Country Medical Director France

Job Description

POSITION SUMMARY:

The Senior Country Medical Director (Senior CMD) France will provide medical leadership for the Medical Department in all assigned therapeutic areas (TA).

The Senior CMD will be accountable for building leading and overseeing the country medical team for the development and implementation of Country Medical strategy and plans and will work in partnership with the Country Manager as well as other cross functional team colleagues to ensure access to companys products develop and implement cross functional country plans aligned with patient HCPs and broader corporate needs.

The Senior CMD is also responsible for building and encouraging scientific excellence within the team close partnerships with HCPs scientific societies and patient organisations across all therapeutic areas.

They will also be responsible for financial planning and budgetary adherence of medical affairs activities.

They will also work closely with a cross-functional group that includes Commercial Market Access Global International Medical Affairs organizations GAPP and Corporate Communications Legal Compliance (OBIE) Regulatory Research & Development HRBP and Finance.

The individual will work closely with and report directly to the Executive Medical Director for the respective region and will be part of the Country Leadership Team.

KEY RESPONSIBILITIES:

General key responsibilities:

• Demonstrate consistent ethical and professional behavior with uncompromising commitment to patients

• Ensure all medical involvement and activities are executed in full compliance with Vertex policies local laws and regulations and codes of practice.
• Build reputation and visibility of Vertex at the country level by providing fair and balanced medical information communication and education to various stakeholders supporting research and relevant data generation with the ultimate goal of supporting the safe and effective use of Vertex medicines in the appropriate patients
• Work closely with the Country Manager to ensure a culture of integrity transparency and respect as per Vertex values throughout the organisation

Medical Strategy

• Develops and ensures flawless execution via the Therapeutic Area Medical Directors of the Country Medical Strategic and Operational Plan aligned with the Global and International Medical strategy and local plans and in accordance with corporate policies and procedures and applicable local laws regulations and code of practice.
• Oversees data generation studies/projects to enhance medical-scientific knowledge in the Therapeutic Area(s) and ensures implementation of RWD initiatives and LCM plans in country through the Therapeutic Area Medical Directors
• Ensures feedback on Global Development Programs is provided to ensure local needs are taken into account

Scientific Excellence

• Develop and maintain high level clinical and scientific knowledge in all Vertex therapeutic areas.

Team/people management

• Provides leadership to dedicated medical team
• Recruits develops manages and coaches the medical team
• Ensures formal goal-setting appraisals individual development plans (IDPs) take place in a timely and structured manner
• Maintains a seamless flow of information within and between the local structure and the International HQ and communicate medical insights obtained locally from appropriate field interactions to inform local and regional strategy/ tactics.

External partnerships

• Ensures excellent working partnerships are developed with Health Care Professionals (HCPs) based on scientific excellence and trust through the medical teams
• Partners with HCPs to provide and obtain insights on therapeutic area issues and questions
• Establishes relationships with key External Experts of ever Therapeutic Area
• Oversees advisory collaborative and/or educational activities aligned to the Vertex strategy
• Contributes to transparent and successful partnerships with national scientific societies patient organisations relevant payers policymakers and relevant industry associations

Medical Communication:

• Ensures that fair and balanced medical information and education is provided to health care professionals and HTA/payer stakeholders that support the safe and effective use of Vertex medicines in the appropriate patients
• External presentations (local 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

• Ensures adequate internal training is provided to medical and XFT

Compliance and Pharmacovigilance:

• Ensures compliance of medical activities at country level with country Code of Conduct rules and regulations company policies SOPs GCP and ICH
• Organizes assessment of local promotional materials and ensure that all claims are fully supported by scientific data and are presented in an accurate fair and balanced manner
• Ensures self and other country medical staff have the required skills to identify and report AEs appropriately
• Contributes to managing external communication when significant safety issues arise with the wellbeing of patients being the ultimate goal

Disease State Portfolio Brand and Access support

• Works in partnership with the Country Manager as well as other cross functional team (XFT) colleagues to ensure that the appropriate patients have fair access in a safe and effective manner develop and implement country cross functional plans aligned with patient HCPs and broader corporate needs.
• Ensures 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
• Takes team 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
• Responsible for ensuring medical interpretation of data (clinical trials registries published literature etc.) for in-development compounds and marketed medicines in all therapeutic areas
• Ensures the medical team provides medical education and appropriate medical scientific support to XFT colleagues as needed
• Ensures that the team keeps product and pipeline information up to date based on internal and external publications

Cross functional collaboration

• Works closely with internal and key external stakeholders supporting Vertex strategy and bringing medical insights as well as support for HTA bodies media government and patient group activities including policy development corporate initiatives and issues management
• Maintains a seamless flow of information within and between the local structure and International Medical Affairs and communicate medical insights obtained locally from appropriate field interactions to inform local regional and global strategy/tactics
• Contributes to the development of the broader aims of the country organization such as country strategy & plans policy development financial planning budgeting
• Strategic alignment working cross functionally and partnering with other key functions at Vertex such as Commercial Market Access HEOR Regulatory and Corporate Communications
• Ensures own and team responsibilities and goals are aligned with the long term aims of the organization and other departments
• Provides input and contributes to the global Therapeutic Area/s strategic imperatives Medical Affairs objectives and tactics.
• Accountable for supporting the Regional Medical Lead in the development implementation and execution of the Regional Medical Strategy and plan for pipeline and in market products
• Keep close interaction and communications with Global and International Medical Affairs functions
• 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

Other Medical activities:

• Facilitates appropriate and adequate implementation of compassionate use programmes in country
• Ensures sourcing accurate epidemiology data in collaboration with local registries/other stakeholders as applicable
• Ensures medical team supports Investigator Initiated research aligned with strategic areas of interest and in a compliant fashion
• Ensures appropriate Steering Committee meetings and advisory boards are held in accordance with local and company regulations. As appropriate leads such initiatives. As applicable

Clinical Trials

Facilitates scientific and thought leader medical affairs expertise into the feasibility site selection recruitment and issue resolution for Vertex Clinical Development Studies in the country led by the Regional Site Advocate (RSA)

EDUCATION:

Medical Degree and/or a higher degree or PhD in life sciences (Fluency in both spoken and written English required)

SKILLS & EXPERIENCE:

Vertex Values and Behaviours

The incumbent must demonstrate ability for:

• Developing and maintaining high level of industry regulatory clinical and scientific knowledge
• Maintaining a high level of expertise and judgment in relation to both technical and ethical aspects of a Medical Directors role and responsibilities

• Having a strong commitment to achieving corporate objectives while maintaining the highest ethical regulatory and scientific standards

• The Senior Country Medical Director is expected to champion a we wins attitude actively collaborating across functions fostering teamwork and establishing mutual support and trust in the fearless pursuit of excellence the courage to start the passion to finish with an uncompromising commitment to patients

Skills & Experience:

• High ethical and scientific personal standards required
• Substantial experience in the pharmaceutical/biotech industry and a proven track record in country medical affairs including broad supervisory/management experience
• Experience in managing several therapeutic areas is required
• Experience in in orphan diseases desirable
• Leadership skills and experience
• Track record of successfully leading a team
• Experience with product launches and life-cycle management preferable
• Track record in effectively managing risk and compliance
• Strong Business Acumen Knowledge and understanding of marketplace dynamics knows the local health care system and keeps up-dated on changes in environment in the country including rules and regulations
• Previous track record of successful HTA submissions
• Ability to work effectively in a highly matrix environment within a multi-disciplinary and multi-cultural team on common projects and goals at national and international level.
• Excellent communication and presentation skills
• Learning agility
• Ability to travel to meetings/trainings/programs as required

#LI-SG1

#LI-Hybrid

Flex Designation:

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 Vertexs 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 persons 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