Head of Medical Affairs Oncology, Spain

**JOB FUNCTION**:

- Provide Therapeutic Area leadership
- Ensure operational collaboration with other departments for Therapeutic Area(s)/ Takeda products of responsibility (e.g. Market Access, Marketing & KAMs and other internal stakeholders) to develop of Cross-brand therapeutic strategy
- Ensure local medical TA/product and MSL strategy development and implementation
- Ensure the correct interpretation and communication of scientific data of Takeda products in TA
- Advocacy for patients needs

**ACCOUNTABILITIES**:

- **Medical/Scientific Affairs**:

- The TA head oversees the development and execution of local strategic medical plans inline with product Life Cycle Management plans (including the production of local publications, planning and conduct of local Advisory Board meetings etc.).
- The TA head ensures Medical / scientific support and expertise is provided - internal(coordination across functions) and external product expert (key research networks /institutions )
- Ensure a local publication plan is created and executed, if relevant, in accordance to the LCM of the asset(s) in alignment with Global and Regional Medical and Local Market Access functions.
- Provide medical expertise to LOC Market Access, e.g. Pricing & Reimbursement Dossier creation
- Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality Assurance
- Provide scientific input into Marketing strategy and tactics
- Provide medical input for development of promotion material
- Certify scientific accuracy and validity of promotional and non-promotion material and its compliance with Takeda standards, SOPs and national laws
- Assess scientific content and relevance (i.e. agenda), speakers and attendees of promotional and non-promotional events sponsored and/or supported by the company.
- Continuously screen, review and analyse scientific literature; generate summaries &critical assessments if appropriate
- Provide environmental and competitive intelligence (Coordination of input from MSLs and MAs)
- Ensure medical training for allocated therapeutic area, e.g. training of MSLs and overall product team (Medical Affairs, Commercial, Market Access and Sales)
- Budget responsibility for medical affairs activities related to TA/product
- Present, as appropriate, the clinical evidence to internal and external stakeholders in anon-promotional way, e.g. reimbursement bodies
- Communicate and align with Regional and Global Medical Affairs functions
- Establish and maintain strong relationships with Key Opinion Leaders (KOLs) and patient associations; ensure medical TA team are similarly engaged
- Evaluate new compounds and pipeline projects (together with Med. Adv. and Med. Dir.and MA)
- Identify gaps in the local clinical study program which are a hurdle for successful regulatory and/or clinical acceptance of the product and propose studies to address these issue
- Ensure extensive, clear and structured briefing to external presenters/speakers at Takeda sponsored medical events are in place e.g. local Advisory Boards, doctors’ meetings.
- Evaluate and support local investigator initiated research proposals in alignment with global strategy and Takeda standards and SOPs
- **Leadership**:

- TA leadership. The TA head will provide leadership to Medical Manager, Medical Leads, Advisors and MSLs
- Supervision of team processes and metrics (KPIs) to ensure consistency across TA.
- Lead local processes to hire new medical personnel for the TA
- Leverage of strong leadership culture in order to develop and bind highly qualified employees to the company and to offer stimuli for reaching ambitious objectives
- Support on-boarding, training and knowledge transfer together with Regional Medical Affairs (RMA) within the medical department

Cross-functional Collaboration
- Ensure awareness and communication of medical activities to other departments within the Local organization
- Participate in local product committees and brand planning cycles; owner of medical part of brand plan
- Work closely with internal stakeholders including Marketing, Market Access, Regulatory and Compliance
- **Clinical Development**:

- Coordinate local trial design - study outline and protocol for local post-authorization(phase 4) and other RWE studies sponsored by Takeda; coordinate/oversee study conduct, data analysis and disclosure, reporting/publication
- Collaborate with Global Development Operations functions (e.g. LOC Support)
- Promote, encourage and demonstrate commitment to Takeda-ism philosophy and values
- Communicate any adverse reaction as soon as it is identified to the Pharmacovigilance Department as detailed in the company’s internal procedures
- Act according to Corporate, Compliance, Ethical codes and Legal standards.

**EDUCATION, EXPERIENCE, SKILLS, KNOWLEDGE**
- **Education**:

- Preferred Doctor in medicine degree (M.D.). If not, degree in health science with a PhD in area related with Medicine
- Medical specialty or PhD