Job Description

General Summary

The Medical Affairs Senior Medical Director provides medical and scientific leadership in the assigned Therapeutic Area(s) (TA). This role will work closely with a cross-functional group to ensure that scientific and medical strategies are aligned with broader corporate and key stakeholder needs and will ensure the flawless execution of Nephrology medical plans.

Key Duties And Responsibilities

• Ensure all medical involvement and activities are executed in full compliance with Vertex policies, local laws and regulations and codes of practice.
• Continue to build reputation and visibility of Vertex at the regional and 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 designated region medical leadership to ensure a culture of integrity, transparency and respect, as per Vertex values, throughout the organization.
• Align medical strategy with organizational goals by ensuring own and team responsibilities and goals are aligned with the long-term aims of the organization and other departments.
• Develop and ensure flawless execution, via the medical team, of the designated disease area Medical Strategic and Operational Plan, in accordance with corporate policies and procedures and applicable local laws, regulations and code of practice.
• Provide strategic regional input 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 the region, as appropriate.
• Provide feedback on Global Development Programs to ensure local needs are taken into account.
• Accountable for supporting the Regional Medical Leads in the development, implementation and execution of the Regional Medical Strategy and plan for pipeline and in market products.
• 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 in the designated disease area and good knowledge of all Vertex disease areas.
• Provide strong leadership inspiring and empowering a dedicated medical team and promoting a culture of continuous development.
• Accountable to recruit, develop, manage and coach the designated location 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.
• Ensure formal goal-setting, appraisals, individual development plans (IDPs) take place in a timely and structured manner.
• Ensure excellent working partnerships are developed with Health Care Professionals (HCPs) based on scientific excellence and trust.
• Continue to maintain and establish relationships with External Experts to expand research opportunities.
• Develop and execute at regional and support 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.
• 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 stakeholders’ needs, building trust and understanding across diverse audiences.
• Ensure adequate internal training is provided to medical and XFT, contribute individually as appropriate.
• Ensure compliance of medical activities at country level with country 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.
• Contribute to managing external communication when significant safety issues arise, with the wellbeing of patients being the ultimate goal.
• Work 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.
• Ensure 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.
• Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development compounds and marketed medicines for the region.
• Keep product and pipeline information up to date based on internal and external publications.
• Work closely with key internal and external stakeholders, supporting Vertex’ strategy and bringing medical insights as well as supporting 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 designated region Medical Affairs, and communicate medical insights obtained locally from appropriate field interactions to inform local, regional and global strategy/tactics.
• Strategic alignment working cross functionally and partnering with other key functions at Vertex such as Commercial, Market Access, HEOR, Regulatory and Corporate Communications.
• Work in strategic partnership with Regulatory, Pharmacovigilance, Medical Information, Clinical Development, Global Clinical Operations and Health Economics Outcomes Research teams in medical scientific questions.
• Ensure own and team responsibilities and goals are aligned with the long term aims of the organization and other departments.
• 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 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 manner.
• Ensure appropriate Steering Committee meetings and advisory boards are held in accordance with local and company regulations. As appropriate leads such initiatives.