About the position
The Medical Lead, Oncology, MA-US (Medical Affairs-United States) at Astellas Pharma Inc. is a pivotal role responsible for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA). This position is integral to ensuring that the company's innovative therapies are effectively communicated and supported within the medical community. The Medical Lead will oversee the creation and management of internal product and TA strategies, ensuring alignment with the global Core Medical Plan (CMP). This includes strategic oversight of data generation activities and other Medical Affairs tactics, as well as the review and endorsement of scientific exchange materials and product launch operations. The role requires collaboration with key stakeholders across the company to support business objectives for the US region, leading the Regional Medical Team (RMT) when applicable, and ensuring alignment with Medical Affairs colleagues within the region. In this role, the Medical Lead will be accountable for the oversight and execution of MA-sponsored clinical studies, driving the scientific and medical development of study protocols and reports, including health economic outcomes research (HEOR) studies. The position demands a strong ability to collaborate and lead within matrix product/TA teams across multiple disciplines, representing Medical Affairs in the relevant Core Medical Team (CMT) and ensuring timely execution of CMP tactics. The Medical Lead will provide medical expertise and approval for promotional and non-promotional materials, review Medical Information response letters, and initiate medical advisory boards to shape medical strategies. Additionally, the role involves partnering with the medical science liaison (MSL) team to translate insights into regional and global strategies, collaborating with Regulatory Affairs and Pharmacovigilance, and leading scientific reviews of investigator-sponsored research proposals. Astellas emphasizes a culture of compliance and integrity, and the Medical Lead is expected to embody the Astellas Way while fostering a collaborative environment. The working environment supports a hybrid model, allowing for a balance between in-office collaboration and remote work, optimizing productivity and work/life balance for all employees.
Responsibilities
- Lead the development and execution of strategic medical plans for assigned products within the Therapeutic Area (TA).
- Accountable for oversight and execution of MA-sponsored clinical studies.
- Drive scientific and medical development and approval of study synopsis, protocols, and reports, including HEOR studies.
- Align with peer leaders in the Commercial organization and cross-functional teams to provide strategic medical direction.
- Represent Medical Affairs in the relevant Core Medical Team (CMT) and ensure timely execution of CMP tactics.
- Provide medical expertise and approval of promotional and non-promotional materials.
- Review and approve Medical Information response letters.
- Initiate and support medical advisory boards to shape medical strategies.
- Partner with the MSL team to translate insights into regional and global strategy.
- Collaborate with Regulatory Affairs and Pharmacovigilance in product labeling and safety reports.
- Lead scientific review of investigator-sponsored research proposals and chair Regional ISR Committee if applicable.
- Provide medical expertise related to new product licensing and acquisition opportunities.
Requirements
- Medical Degree (MD)
- Minimum 3 years' experience in the pharmaceutical industry with a clinical or academic background after residency training.
- Experience working in a matrix organization collaborating with various departments.
- Solid scientific analytical and problem-solving skills, strategic capabilities, project management, and organizational skills.
- Ability to communicate effectively, including scientific concepts, in writing and oral presentations.
- Ability to design and conduct various phases of clinical trials and critically review study designs.
- Ability to collaborate within matrix structured product teams across multiple disciplines.
- Ability to effectively engage internal and external stakeholders and collaboration partners.
- Demonstrated ability to build strategic alignment within the Medical Affairs community and across functions.
- Fluent in written and verbal English.
Nice-to-haves
- Minimum 3 years of Medical Affairs relevant experience within the pharmaceutical industry.
- Postgraduate qualification and specialization in an appropriate therapeutic specialty preferred.
- Board Certified in relevant therapeutic area.
- Active medical license.
- Experience in medical research.
- Extensive knowledge of US healthcare delivery systems and policy issues.
Benefits
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, and national holidays
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Referral bonus program
