Global Medical Affairs Lead
About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
As a Global Medical Affairs Lead, you will be globally responsible for Medical Affairs (MA) activities for assigned products in late-stage development, post-launch, and for life cycle management (when required). This position will support the MA Global Strategic Brand Lead (MA GSBL), facilitating collaboration across a matrix organization to ensure the creation and execution of the Core Medical Plan (CMP) and the integrated evidence generation plan (iEGP).
The CMP includes MA-sponsored data generation, including Health Economics and Outcomes Research (HEOR), to address existing and future data gaps and support reimbursement needs. The Global MA Lead is responsible for identifying the information needs of external stakeholders, such as data generation for healthcare professionals (HCPs) and payers, data communication, and medical education. This position also supports routine and ad-hoc assessments of the benefit-risk profiles of assigned products.
When required, the Global MA Lead shall represent the MA GSBL at Astellas senior leadership meetings (e.g., Global Benefit Risk Committee [GBRC], Medical Affairs Leadership Team [MALT]). The Global MA Lead shall collaborate closely with the Global Commercial Team (GCT), ensuring the creation and execution of an integrated Global Brand Plan (iGBP). Collaboration with Development will support clinical development programs for new indications or line extensions for marketed products.
At Astellas, we recognise that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
You will be part of an inclusive team that works to develop innovative therapies for patients.
Key Activities for this role:
- Supporting Core Medical Plan Development and Execution: Collaborate with the MA GSBL to develop and execute the Core Medical Plan (CMP) for assigned products effectively and on time.
- Centralised Medical Content Creation: Support the creation and delivery of centralized medical content for medical education, scientific exchange, and training—both internal and external.
- HEOR Collaboration for Gap Analysis: Partner with the Health Economics and Outcomes Research (HEOR) lead to identify gaps, address these in the CMP, and support the creation of Core Value Dossiers to facilitate access and reimbursement strategies.
- Regulatory and Reimbursement Strategy Contributions: Possess a strong understanding of the regulatory and reimbursement landscape and contribute to shaping strategies to support the product's success.
- Cross-functional and Cross-regional Collaboration: Work within matrix teams and with global affiliates to align key medical affairs projects and ensure effective cross-regional and cross-functional teamwork.
- Engaging with Global Experts and Key Insights: Build and maintain relationships with global experts to gather valuable scientific insights that can influence therapeutic area (TA) strategies.
Essential Knowledge & Experience:
- Significant industry experience, including country/region or global medical affairs, medical safety, or clinical development, with extensive Medical Affairs experience.
- Demonstrate expertise in Therapeutic Area (TA)/disease/product and is able to operate across several products within the TA.
- Proven success in leading the brand medical affairs strategy, including product launches.
- Strong ability to develop innovative, patient-centered medical affairs evidence generation and dissemination strategies that drive patient access and brand performance.
- Exhibit proficiency in TA/disease/product and is able to operate across multiple products within the TA.
- Possess a thorough understanding of rules and regulations in pharma, including knowledge of global regulatory bodies and procedures, as well as anti-kickback laws, which could impact the pharmaceutical industry. Appropriate knowledge of guidelines and regulations such as IFPMA (International Federation of Pharmaceutical Manufacturers Association), PhRMA (Pharmaceutical Research and Manufacturers of America), FDA, EMA, PMDA, ACCME, and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities.
Education/Qualifications:
- A medical degree (MD or equivalent) or Doctorate degree in Pharmacy or Pharmacology recognized by one of the leading governing bodies from around the globe or equivalent.
Additional Information:
- This is a full-time, permanent.
- This is located in our Poland office (Warsaw).
- This position follows our hybrid working model. The role requires a blend of home and minimum 1 day per quarter in our Poland office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
What We Offer:
- A challenging and diversified job in an international setting.
- Opportunity and support for continuous development.
- Inspiring work climate.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.