At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional business results.
Everyone at Astellas has a responsibility for creating a brighter future for patients around the world. From the first moment, Astellas will inspire you to put this ethos into practice – with a positive, agile company culture and with well-defined ethical principles, values, and systems.
Everything we do is led by our company values of integrity, being patient centric, taking ownership, delivering results, and communicating openly. These values are essential to Astellas’ relationship with its employees and now is an exciting time to join us as we continue to evolve as a cutting-edge, value driven life sciences innovator.
Purpose of the Position:
The incumbent will be accountable for the development, execution, and oversight of medical and scientific strategies for one or more products within the Therapeutic Area (TA). You will be responsible for:
- Proactive assessment of external medical environment perspectives that shape global medical strategies.
- Management and execution of data generation activities that clearly demonstrate product value and are aligned with global strategies.
- Review and approval of scientific exchange materials
- Internal product/TA training content strategy
- Representation of the Int-M region within the Core Medical Team (CMT)
- Working closely with key stakeholders across the company to support business objectives for Int-M Region, providing matrix leadership for a team of regional affiliates in the region in support of Global strategy, and ensuring alignment with and support of Medical Affairs (MA) colleagues within the Int-M Affiliates.
Responsibility
- Drive and oversee the development and execution of robust Int-M strategic medical plans for the assigned products within the TA that are aligned with the global Core Medical Plan (CMP).
- Provide scientific and clinical expertise to develop and approve high-quality study synopsis, protocols, and study reports, including Health Economic & Outcomes Research (HEOR) related studies, utilizing clear understanding of life cycle management, portfolio strategy and competitive landscape across disease area.
- Accountable for oversight and execution of MA-sponsored clinical studies within area of responsibility except safety monitoring of patients.
- Sought out by internal and external stakeholders as an expert on matters relating to the TA, including external medical insights and mentoring/training of colleagues across the TA.
- Align closely with peer colleagues in the Commercial organization and leads/co-leads cross functional teams, providing strategic medical direction to support the needs of the business.
- Effectively lead and influence within matrix product and TA-related teams.
- Work closely with and provide medical direction to Medical Science Liaison leadership team.
- Represent Int-M on the relevant CMT, including representation of all regional needs and activities and timely execution of the CMP tactics.
- Provide medical expertise and approval of promotional materials.
- Provide medical expertise and approval of non-promotional medical materials, including but not limited to slide presentations, local dossiers, health outcomes models, etc.
- Initiate and chair medical advisory boards to understand and shape medical strategies.
Requirements
- Doctoral degree (e.g., PharmD, PhD, MD, DO).
- Minimum 5 years academic or clinical experience following post-doctoral training and 5 years Medical Affairs relevant experience in pharmaceutical industry in Ophthalmic.
- Minimum 5 years matrix leadership experience.
- Experience in collaborating with medical, clinical, regulatory, health economic and outcome research, medical information, commercial and other cross functions to deliver results.
- Strong scientific analytical and problem-solving skills, strategic capabilities, project management and planning skills.
- Ability to communicate effectively, including complex scientific concepts, both in writing and in oral presentations.
- Demonstrated ability to design and conduct various phases of clinical trials, including ability to critically review and analyze study designs.
- Fluent in written and verbal English.
- Approximately 20% travel required.
- Demonstrated strong interpersonal relationship and collaboration skills working within cross- functional executive leadership teams preferred.
- Thorough understanding of FDA/PhRMA, OIG, Health Canada/Innovative Medicines Canada, ANVISA/ANS and other guidelines as they relate to HEOR and Medical Affairs preferred.
