Associate Director, Medical Affairs

Job Description

The Associate Medical affairs Director (AMD)- Haematology provides medical leadership for specific projects within the Haematology Therapeutic Area (TA) in Spain. S/he is the lead and subject matter expert for Vertex medicines in this TA. This role reports directly into the Country Medical Affairs Director (CMD).

The AMD acts with an uncompromising commitment to patients and ensures the flawless execution of TA country medical plans, and is committed to:

• Provide fair and balanced medical information and education to health care professionals and payers that support the safe and effective use of Vertex’ medicines in appropriate patients
• Build trust through open and transparent collaboration with health care professionals, patient associations and payers
• Develop collaborative networks inside and outside Vertex to access best ideas, expertise, and capabilities
• Develop and strengthen country medical affairs’ credibility within and outside of the organization
• Demonstrate consistent ethical and professional behavior, with uncompromising commitment to patients
• Know the local health care system and keep up-dated on changes in environment in the country, including rules and regulations
• Build reputation and visibility of Vertex at the country level by the provision of high-quality medical information and education both internally and externally
• Actively participate to the European TA Medical Affairs Team(s) and European Medical Affairs Team, bringing back best practice from country projects and proposing processes improvement for MA activities in the affiliate and, where appropriate, across EU MA team
• Provide support in the assigned TA to the country team:
• Foster best practice exchange and cross-fertilization among the country medical staff
• Pro-actively collaborate in cross-functional teams at country level
• Contribute to the local Brand Team, representing the TA (scientific and medical expertise) and ensuring all activities address patient well-being and respect data integrity
• Create, or co-create, and fully execute specific aspects of the Country Medical plan(s) agreed with the Therapeutic Area (TA) leads and CMD
• Foster patient access to Vertex drugs, by supporting the commercial organization in the preparation/review of reimbursement dossiers and presenting scientific data as required to key stake holders in the access process
• Provide local feed-back to TA Leads for Global Development Programmes, to ensure local needs are taken into account
• Support as needed the execution of clinical development trials in the country.

Key responsibilities:
 

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

 

Brand and Access support:

• Work in partnership with the Commercial and marketing leads as well as other cross functional team colleagues to ensure access to company’s products and develop and implement brand plans aligned with patient, HCPs’ and broader corporate needs.
• Ensure highest level of support and contribution to access efforts through the preparation/review of reimbursement dossiers, scientific engagement of key stakeholders and presentation of scientific data as required to key stakeholders in the access process
• 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 and marketed medicines;
• Providing medical education and appropriate medical scientific support to cross-functional colleagues as needed
• Keeps product and development project information up to date based on internal and external publication.

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
• Responsible for building and maintaining transparent and successful partnerships with national scientific societies, patient organizations, HTA bodies and relevant payers.

 

Cross- funcional collaboration:

• Work closely with internal and key external stakeholders supporting Vertex’ strategy and bringing medical insights as well as support for 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 Country organization e.g., brand strategy & plans, policy development, financial planning, budgeting
• Strategic alignment of the HEME program working cross functionally and partnering with other key functions at Vertex such as Commercial, Regulatory, Market Access, HEOR, and Corporate Communications
• Ensure own 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 strategic imperatives, Medical Affairs objectives and tactics.
• Accountable for supporting the CMD in the development, implementation and execution of the Medical Affairs Strategy and plan for pipeline and in market products
• Keeps close interaction and communicates with Global and Internationation medical affairs functions
• Support Regulatory, PV/MI, Clinical Research and health economics teams in medical scientific questions
• Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals.

Medical education:

• Provide fair and balanced medical information and education to health care professionals and payers that support the safe and effective use of Vertex’ drugs in the appropriate patients
• Internal (mainly marketing and sales functions) and external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products.

Compliance and Pharmacovigilance:

• Ensure compliance at country level with country Code of Conduct, company policies, medical affairs 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 AEs and assess causality of PV cases
• Contribute to managing external communication when significant safety issues arise, with the wellbeing of patients being the goal.

Other Medical activities:

• Ensures appropriate and adequate implementation of compassionate use programmes in country
• Participates 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 Ensures implementation of RWD initiatives and LCM plans in country, as appropriate
• Ensures medical team supports Investigator Initiated research aligned with strategic areas of interest and in a compliant fashion
• Review clinical trials and community-based grant requests, as needed.

Ensures appropriate Steering Committee meetings and advisory boards are held in accordance with local and company regulations. As appropriate leads such initiatives


Key requirements:

The AMD is expected to champion a “we win” 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 uncompromised commitment to patients.

• Medical Degree or PhD (Fluency in both spoken and written English required)
• Experience in Medical Affairs and Drug development within the biotechnology or pharmaceutical industry with significant experience of reviewing promotional and non-promotional experience
• Availability to travel 50% of the time across Spain and attendance of internal and external meetings internationally
• Experience in Hematology, Cell and Gene Therapy or orphan drugs.
• Skilled in working in cross-functional matrix teams
• Ability to develop and maintain strong relationships with external experts within a TA
• Experience in designing, planning, and executing medical education and communication activities
• Familiarity with clinical trial processes across different phases of development and resolving clinical trial-related issues
• Good understanding of statistical methods
• Experience in writing or reviewing scientific communications
• Cognizant of local reimbursement processes, of product-specific pricing issues and understanding of required medical contribution to pricing/reimbursement dossiers
• Knowledge of key Marketing and Market Research terms and modes of analysis
• Track record in effectively managing risk and compliance.

#LI-SM1 #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 ApplicationAssistance@vrtx.com.
 

Job Information

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

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.

#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.

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 ApplicationAssistance@vrtx.com