EU Medical Director, Rare Diseases

Otsuka Pharmaceutical Europe is proud to be an equal opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all Employees. All qualified applicants will receive consideration for employment regardless of their race, colour, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or any other protected status. Otsuka Pharmaceutical Europe is committed to ensuring our hiring process is accessible to everyone. Should you require any accommodation or adjustments during the application or interview process, please do not hesitate to let us know. Job Description Summary Responsibility for Medical Affairs activities for Rare Disease therapies with marketing authorization as well as those in our pipeline. This individual will be charged with establishing a close partnership with the Global and OPEL cross functional teams within the company and also with our Alliance and / or collaboration partners, supporting access to our therapies in all relevant markets, and providing input to European life cycle management programmes. RODUCT / BRAND REFERENCE POINT Continuously update own knowledge of products, therapeutic landscape, patient treatment / healthcare trends and access / regulatory developments within the Disease Area Act as 1st point of contact for the Global Clinical Development and relevant CRO teams Act as a 1st point of contact for the Country Medical Directors for clinical and non-clinical activities particularly for data dissemination Act as 1st point of contact for medical & clinical queries for the Global, OPEL and Affiliate Market Access and Regulatory teams Act as Medical Affairs Lead for relevant product OPEL Brand team(s) Ensure delivery of OPEL led Medical Affairs Strategy and relevant tactics Direct budgetary responsibility COMPLIANCE : Endorse and implement a culture of compliance Adhere to all internal and external rules and regulations Convey a clear message on legal and ethical standards to Kols , Investigators and HCPs Develop an understanding and competence of SOPs, GCP and ICH, as well as legal and ethical standards Immediately alert management or the Compliance Department to any possible compliance issues Work with Global and Regional teams to ensure cross border needs are met in a timely manner CROSS-FUNCTIONAL and CROSS-REGIONAL LEADERSHIP : Support the development of the OPEL Medical Rare Disease Team, which consists of Regional Medical directors, Scientific advisers and MSLs Contribute to the development of the annual Regional Medical Plan, strategically aligned with and integrated with the Brand Plans, and ensure alignment with Global Strategy focusing on medicais affairs activities Coordinate interactions among Regional Regulatory, Marketing, Outcomes Research, and Pharmacovigilance for all pan European medical activities including IISs Partner closely with the OPEL and Regional Ethics & Compliance, Legal and Data Privacy teams as required Integrate into the cross-functional Brand team(s) as the Medical Affairs lead for medical & clinical input Work closely with OPEL Market Access to ensure all scientific / clinical / medical knowledge is integrated into e.g. GVDs, HTA dossiers, core claims documents etc. Embed into Global Clinical and Medical Affairs teams to ensure that clinical trials or IST or any medical activities conducted in Europe are strategic in approach and compliant in execution Partner closely with Global Regulatory teams to support strategic discussions on label requirements Facilitate sharing of best practice and knowledge across countries Work closely with team-mates within the OPEL Medical Affairs team such as Medical Excellence, Medical Information, Patient Advocacy, RWE to ensure timely and efficient transfer of relevant knowledge EXTERNAL EXPERT MANAGER : Work with the European Medical Team to identify top External Experts across the region and develop strong scientific and medically based interactions with them Select and manage regional External Experts advisory board members, in collaboration with the Medical and Commercial directors or our partner as required MATERIAL CONTRIBUTOR & REVIEWER : Assess promotional materials to ensure that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner. Contribute to the scientific content of promotional material, drawing on relevant scientific data and External Expert insights. Review & approval of Promotional and non-promotional materials as per need offline and in Promo Mats Assess materials in line with the SOPs, clearly express rationale for any objections SUPPORT & TRAINER : Ensure the regional commercial team receive initial andon-going medical training - in collaboration with the European Affiliate Medical Directors and / or other Medical Manager(s) - enabling them to understand and convey the scientific benefits of a Brand appropriately. Review training documents developed at regional level for commercial teams to check medical accuracy and compliance with regulatory requirements Develop and deliver training to medical teams across the region on Otsuka products, medical concepts and available therapies Translate scientific and clinical data into meaningful relevant medical information for health care professionals that ensure appropriate use of Otsuka products to secure optimal outcomes for patients Support high quality medical activities such as Continuous Medical Educational Programs and Symposia Develop and deliver presentations and prepare speakers for Otsuka symposia, in collaboration with relevant members of our partner, the Regional Medical / Brand Team Develop Regional publications strategies and influential scientific publications Develop and deliver materials for use by medical teams when communicating with HCPs and ensure that the medical teams are adequately trained on the materials CONTRIBUTOR TO CUSTOMER FOCUSED ACTIVITY : ADDITIONAL JOB DESCRIPTION LEADERSHIP & BEHAVIORAL COMPETENCIES FOR THIS POSITION ARE Focus on the needs and perspectives of colleagues and customers. Learn, apply and share lessons from experience. Embrace and adapt to change. Challenge the status quo to simplify work and improve results. Seek new information and external insights to improve the company’s results. Identify and take informed business risks, escalating issues if needed. Generate new ideas or alternatives that create value. Make and act on decisions while balancing speed, quality and risk. Use input from key stakeholders and engage in constructive dialogue to make decisions. Communicate rationale and support decisions once made. Communicate directly, openly and honestly. Build strong relationships by being transparent, reliable, and delivering on commitments. Listen, seek to understand, and ask questions. Support fellow team members to meet shared goals. FUNCTIONAL & TECHNICAL COMPETENCIES FOR THIS POSITION ARE Communication / development / medical affairs experience in the area of Rare diseases(essential) In depth knowledge of the ABPI code and final signatory requirements (essential) Managing cross-cultural teams across a region (essential) Working in a complex, changing, multinational and matrix environment (essential) Contributing to medical publications and presentations (essential)Working across and building effective working relationships between Medical, Marketing and other relevant functions (essential)Conducting complex negotiations within a pharmaceutical environment, both internally and externally (essential)Budgeting, aligning local and regional plans (essential)Advanced scientific and / or clinical degree - essentialPharmaceutical Industry experience of at least 7 years in medical affairs & R&D - essentialExperience of drafting clinical trial protocols & leading clinical trials – essentialExperience of writing & publishing clinical / scientific manuscripts in peer-reviewed journals – essentialKnowledge of medical information, PV and QA requirements - essentialDetailed HTA support experience (writing and reviewing of GVD / HTA dossiers etc) in several EU countries – essential Experience in launching in Rare Diseases – essential Experience supporting Regulatory teams on the preparation and reviewing of SmPC according to EMA requirements - essential Detailed knowledge of the ABPI and EFPIA code - essential Final Signatory according to the ABPI Code or qualified to train as one – desirable #J-18808-Ljbffr