Medical Director, Medical Affairs

Job Description

General Summary:

The Medical Director, cystic fibrosis (CFMD), will report to the Senior Country Medical Director and will be accountable for the Therapeutic area medical strategy in Italy. She/he will be accountable for building, leading and overseeing the Cystic fibrosis (CF) medical team, for the development and implementation of CF Medical strategy and plans. She/he will work closely with the cross functional team colleagues to ensure access to company's products, develop and implement cross functional country plans aligned with patient, HCPs' and broader corporate needs. CFMD is also responsible for building and encouraging scientific excellence within the team, close partnerships with HCPs, scientific societies and patient organisations. She/he will also be responsible for financial planning and budgetary adherence of medical affairs activities related to Cystic fibrosis.

Key Duties and Responsibilities:

• General key responsibilities:

• Drives CF Country Medical Affairs strategy
• Manage and develop direct reports (MSLs)
• Demonstrate consistent ethical and professional behaviour, with uncompromising commitment to patients
• Ensure all medical involvement and activities within the Therapeutic area 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 for Cystic fibrosis 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 a cross-functional group that includes Commercial, Market Access, Global, International Medical Affairs organizations, Patient Engagement, Governmental affairs and Public Policy, Corporate Communications, Legal, Compliance (OBIE), Regulatory, Research & Development, HRBP and Finance.

• Medical Strategy

• Develop and ensure flawless execution, via the CF medical team, of Italy 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.
• Participate in the development of Life Cycle Management (LCM) Plans for Cystic fibrosis
• Drive data generation studies/projects to enhance medical-scientific knowledge in the Therapeutic Area and ensure implementation of RWD initiatives and LCM plans in Italy, as appropriate
• Provide feedback on Global Development Programs to ensure local needs are taken into account

• Scientific Excellence

• Develop and maintain high level, clinical and scientific knowledge in Cystic fibrosis.

• Team/people management

• Provide strong people leadership inspiring and empowering a CF medical team, including recruiting, developing, managing and coaching
• Navigate ambiguous or rapidly evolving situations, and coach the team during periods of uncertainty or change and promote a culture of continuous development
• Identify and addresses team skill gaps, considering how to accelerate internal talent or attract external to meet needs of a future-ready organization.
• Ensure formal goal-setting, appraisals, individual development plans (IDPs) take place in a timely and structured manner
• Maintain 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

• Ensure excellent working partnerships are developed 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
• Seek partnerships with key external stakeholders to advance Vertex's vision and build transparent and successful partnerships with national scientific societies, patient organizations, relevant payers, policymakers and relevant industry associations
• Develop, at local level, advisory, collaborative and/or educational activities aligned to the Vertex CF strategy
• Contribute to transparent and successful partnerships with national scientific societies, patient organisations, relevant payers and other relevant external stakeholders

• Medical Communication:

• 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
• Delivers 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
• Tailor communications to stakeholder needs, building trust and understanding across diverse audiences.
• Ensure adequate internal training is provided to medical and XFT for Cystic fibrosis, contribute individually as appropriate

• Compliance and Pharmacovigilance:

• Ensure compliance of medical activities with country Code of Conduct, rules and regulations, company policies, SOPs, GCP and ICH
• Assess local promotional materials related to Cystic fibrosis and ensure that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner
• Ensure self and direct reports have the required skills to identify and report AEs appropriately

• Disease State, Portfolio, Brand and Access support

• Work in partnership with the Italy 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 for Cystic fibrosis 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
• Leverage business acumen and understanding of the market to anticipate trends and balance of needs today and the future, and keeping up to date with product and pipeline information based on internal and external publications
• Take individual accountability for reviewing and certification of promotional and non-promotional materials in Cystic fibrosis according to the company SOP and to local country and regional regulations
• Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development compounds and marketed medicines
• Keep product and pipeline information up to date based on internal and external publications

• Cross functional collaboration

• Work 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
• Strategic alignment working cross functionally and partnering with other key functions at Vertex such as Commercial, Market Access, HEOR, Regulatory and Corporate Communications for CF
• Ensure own and team responsibilities and goals are aligned with the long term aims of the organization and other departments for CF
• Provides input and contribute to the global CF strategic imperatives, Medical Affairs objectives and tactics.
• Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals for CF

• Other Medical activities:

• Facilitate appropriate and adequate implementation of compassionate use programmes in CF in country
• 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 fashion

• Clinical Trials

• Facilitate scientific and thought leader medical affairs expertise into the feasibility, site selection, recruitment and issue resolution for Vertex Clinical Development Studies in CF in the Italy led by the Regional Site  Advocate (RSA)
• Medical team successfully contribute to Site Initiation Visits for CF when applicable

Knowledge and Skills:

• 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 Director's role and responsibilities
• Having a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards
• The CF 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 medical affairs
• Experience in the therapeutic area and/or in orphan diseases desirable
• Leadership skills and experience
• Track record of successfully leading a team desirable
• 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

Education and Experience:

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

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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 Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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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