Medical Affairs Director, Diabetes, GCC

Job Description

The Medical Director will be held accountable for the development of the GCC medical strategy and implementation Medical plans across countries and will work in collaboration with cross functional teams to establish the diabetes portfolio along with supporting development of the cross functional country plans through medical insights and market understanding in alignment with patient, HCPs’ and broader corporate needs, also will 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.

This role is based in Riyadh, KSA and require 3 days onsite.

Key responsibilities:

• Demonstrate consistent ethical and professional behaviour, with uncompromising commitment to patients.
• Building and encouraging scientific excellence within the country, establish and maintain close partnerships with HCPs, scientific societies and patient organizations.
• 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 goal of supporting the safe and effective use of Vertex’ medicines in the appropriate patients.
• Work closely with the Regional Team, local Senior Country Medical Director and International team to ensure their behaviour is consistent with a culture of integrity, transparency and respect, as per Vertex values, throughout the organization.

Medical Strategy setting

• Responsible for setting the GCC country level strategy related to diabetes and ensure the development of an actionable robust medical plan that serves the global vision and aspirations.
• Ensure flawless execution, via the medical team, of the Diabetes 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
• Collaborate and participate in the development of Life Cycle Management (LCM) Plans
• 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 country, as appropriate
• Provide feedback on Global Development Programs to ensure local needs are considered.

Scientific Excellence

• Develop and maintain high level, clinical and scientific knowledge in diabetes therapeutic area.
• 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
• Establish relationships with External Experts to expand research opportunities
• Develop, at local 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

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
• External presentations (local advisory board meetings, symposia, other Medical Education meetings) to enhance the medical knowledge of diabetes pipeline and products, as required and in accordance with local regulations and procedures
• Ensure adequate internal training is provided to medical and cross functional team, contribute individually as appropriate

Compliance and Pharmacovigilance

• Ensure compliance of medical activities at the country level with the country Code of Conduct, rules and regulations, company policies, SOPs, GCP and ICH
• Assess 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 medical staff have the required skills to identify and report AEs appropriately
• Contribute to managing external communication when significant safety issues arise, with the wellbeing of patients being the goal

Disease State, Portfolio, Brand and Access support

• Work in partnership with the 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
• Support and contribute 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
• Work with the line manager to ensure individual or team accountability for reviewing and certification of promotional and non‐promotional materials in the respective areas 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
• Ensure Medical team provides Medical Education and appropriate Medical scientific support to XFT colleagues, as needed
• 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
• Maintain 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. Work with the International Centre of Excellence for Medical Education to support and implement appropriate & compliant local Medical Education events
• Strategic alignment working cross functionally and partnering with other key functions at Vertex such as Commercial, Market Access, HEOR, Regulatory and Corporate Communications
• Ensure own and team responsibilities and goals are aligned with the long term aims of the organization and other departments
• Provides input and contribute to the global Therapeutic Area/s strategic imperatives, Medical Affairs objectives and tactics
• 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 from medical perspective.

Other Medical activities:

• 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
• Ensure appropriate Steering Committee meetings and advisory boards are held in accordance with local and company regulations. As appropriate, such initiatives lead.

Clinical Trials

• Facilitate scientific and thought leader medical Affairs expertise into feasibility, site selection, recruitment and issue resolution for Vertex Clinical Development Studies led by the Regional Site Advocate (RSA) (If required)

Key requirements:

• Physician or Pharmacist degree
• Extensive experience in pharmaceutical industry medical affairs within diabetes disease area for ~8 years
• High ethical and scientific personal standards
• Leadership skills and experience
• Experience with product launches and life‐cycle management
• 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 (as applicable)
• Ability to work effectively in a highly matrix environment, within a multi‐disciplinary and multi‐ cultural team on common projects and goals, at regional and international level
• Excellent communication and presentation skills
• High learning agility
• Fluent English and Arabic speaking and writing
• Ability to travel to meetings/trainings/programs as required.

The candidate must demonstrate ability to:

• Developing and maintaining a 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.

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.

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 [email protected]