Senior Medical Director- Haematology - Paddington, United Kingdom - Vertex Pharmaceuticals, Inc

Description

Job Description

The Senior Medical Director (SMD) Haematology will provide medical leadership for the International Medical Department in all Haematology. This is a crucial role and will be effectively a "Player- manager role". The focus of the Medical Affairs team will be external stakeholder engagement, and as such it is desired that the incumbent in this role will do this job as well as leading and managing the team.

As such, the SMD will be accountable for building, leading and overseeing the country Haem medical teams, for the development and implementation of Country Medical Haem strategy and plans and will work in partnership with the Regional Medical leads as well as other 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.

The SMD is also responsible for building and encouraging scientific excellence within the team, close partnerships with HCPs, scientific societies and patient organisations in the country in which they live.

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

They will also work closely with a International 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 International Medical Affairs VP.

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 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 VP GMA-I and the IMALT to ensure a culture of integrity, transparency and respect, as per Vertex values, throughout the organisation

Medical Strategy

• Develop and ensure flawless execution, via the medical team, of the Hematological Medical Strategic and Operational Plan, aligned with the Global Medical strategy and local country 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
• 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

Scientific Excellence

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

Team/people management

• Provide leadership to dedicated medical team as discussed above
• Involved in Recruitment, development, management and coaching the medical team
• 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
• 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 pipeline and marketed products, as required and in accordance with local regulations and procedures
• Ensure adequate internal training is provided to medical and XFT, contribute individually as appropriate

Compliance and Pharmacovigilance:

• Ensure compliance of medical activities at country level with 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 country 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

Disease State, Portfolio, Brand and Access support

• Work 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
• 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
• 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
• Contribute to the development of the broader aims of the regional organization such as regional Haem 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
• 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.
• 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:

• Facilitate appropriate and adequate implementation of compassionate use programmes 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
• Ensure appropriate Steering Committee meetings and advisory boards are held in accordance with local and company regulations. As appropriate leads such initiatives

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 the region and countries led by the Regional Site Advocate (RSA)
• Ensure Medical team delivers successfully Site Initiation Visits.

Key requirements:

• Medical Degree and/or a higher degree or PhD in life sciences (Fluency in both spoken and written English required)
• Experience in relevant Haematological areas/ Cell and Gene Therapies
• Experience of managing and leading Medical Affairs teams
• High ethical and scientific personal standards
• 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
• 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.

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
• SMD 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.

#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.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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