Medical Director EMEA MA (Oncology) - United Kingdom
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We have a new opportunity for a Medical Director with Oncology experience to support and help deliver new products within the Astellas Oncology portfolio. This role carries an EMEA scope and is part of our Global Medical & Development group so requires an individual with good Oncology knowledge to educate and influence at a Global level. Candidates should evidence strong communication and presention skills with the potential to progress as the organisation continues to grow
Purpose & Scope:
The Medical Director is accountable for the medical and scientific strategy for specified products in the Oncology Therapeutic Area.
Responsibility includes ensuring the medical strategy and tactics are in place from inception through to delivery and execution, working closely with key stakeholders across the organisation in alignment with the Astellas business objectives for EMEA
• Lead or facilitate EMEA regional input into Core Medical Plan (CMP) (including HEOR and Phase 3b/4 studies), coordinating medical input from the EMEA affiliates.
• Create and deliver product level training (internally and externally) and provide support in coordinating medical activities at medical/scientific conferences.
• Provide support in agreeing a common approach to the assessment of ISR proposals, understand product label and gaps and manage benefit & Risk assessments.
• Create/ assess clinical study protocol outlines and present/defend in review process.
• Respond to identified data gaps and contribute to Life Cycle Management planning.
• Contribute to development and execution of a data dissemination plan, including as appropriate, writing abstracts and contributing to manuscripts and other publications.
Business Acumen and Strategic Thinking
• Provide external medical and business environment perspective in respect of Oncology in respect of the development and review of the core medical plans.
• Act as regional representative, responsible for budget and timelines for EMEA region medical team related activities, partnering with Astellas Global Development for Life Cycle Management
• This role will hold accountability as full Medical Final Signatory and as Subject Matter Expert and Trusted Advisor will assist/enable all personnel to understand and adhere to the Astellas’ Code of Ethics, associated policies and procedures and SOPS and codes such as ABPI & EFPIA
Regularly undertake and refresh mandatory Healthcare Compliance training in order to maintain knowledge and expertise to enable informed consent and personal accountability.
• Ensure effective cross-regional and cross-functional collaboration; align all key Medical Affairs projects globally for assigned product and indication.
• Contributes effectively within matrix teams across Astellas.
Requirements for the role:
• Medically qualified (GMC will be a priority) or eleigibility for registration with the General Medical Council .
• A good level of experience within a commercial Pharma environment and experienvce and working knowledge of the Medical affairs function and a focus on Oncology (Breast & Gastro experience would be preferred)
• Expertise in the medical sciences, clinical development, medical program design including experience in designing, executing and reporting of clinical trials.
• Experience of managing Medical Affairs budgets with demonstrated ability to apply pro-active risk management on budget and timelines.
• Proven leadership capability in aligning medical strategies with corporate goals and providing critical business shaping insights.
• Knowledge and strong understanding of industry laws and regulations.
• Excellent verbal and written communications and presentation skills; fluent in written and verbal business English.
• Strong interpersonal and networking skills.