Job Description
The Associate Director provides medical leadership for specific projects within a therapeutic area (TA) and aligned to specific medicines. S/he is the lead and subject matter expert for Vertex medicines.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 andpayers 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 organisation Demonstrate consistent ethical and professional behaviour, 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(s) to the country team: Foster best practice exchange and cross-fertilisation 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. General responsibilities: Demonstrate consistent ethical and professional behaviour, 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 who support the safe and effective use of Vertex' drugs 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 compounds; External partnerships: Ensure excellent working partnerships are developed with (Health Care Professionals (HCPs), based on scientific excellence and trust Partner with HCPs to provide insights on current focused therapeutic area issues and questions Responsible for building and maintaining transparent and successful partnerships with national scientific societies, patient organisations, HTA bodies and relevant payers. Scientific Excellence: Develops and maintains high level of industry, regulatory, clinical and scientific knowledge in cystic fibrosis and emerging Vertex therapeutic areas. Clinical Trials: Ensure input into HQ clinical team regarding appropriate country study sites, and support the central clinical development team, as appropriate, in ensuring suitable centre selection and success at these sites Facilitate scientific and thought leader medical affairs expertise into the feasibility, site selection, recruitment and issue resolution for Vertex Clinical Development Studies in the country led by the Regional Site Advocate (RSA) Provide feedback on Global Development Programs, to ensure local needs are taken into account. XFT 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 Cystic Fibrosis 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 SMD 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 Providing medical education and appropriate medical scientific support to XF colleagues as needed Keeps product and development project information up to date based on internal and external publication. 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 ultimate goal. 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