Head, Global Clinical Science & Medical Affairs for Marketed Products
Takeda
5 hours ago
Remote friendly (Cambridge, MA)
United States
$321,000 - $504,460 USD yearly
Medical Affairs
OBJECTIVES/PURPOSE
- Provide global end-to-end medical and clinical science strategic leadership for marketed products, integrating post-approval clinical development, post-marketing commitments, and medical affairs.
- Ensure robust scientific, clinical, and medical oversight across the product lifecycle to safeguard benefit–risk, patient safety, and global regulatory compliance.
- Lead and develop a global organization of physicians, medical affairs leaders, and scientific directors.
- Senior medical/clinical leader for marketed products, partnering with R&D, Regulatory, Safety, Strategy & Portfolio Division, and Commercial Business Units.
- Core member of Marketed Products Medical & Development Leadership Team and chair the Clinical Review Board for marketed products.
ACCOUNTABILITIES
- Global strategic oversight for clinical science and medical affairs for a marketed products portfolio (post-marketing clinical development, lifecycle management, and medical affairs activities).
- Lead the global clinical science and medical affairs organization; ensure scientific rigor and medical governance; contribute strategically to GPTs, CSTs, and MSTs.
- Oversee clinical development plans, post-marketing commitments, Phase IIIb/IV studies, registries, and real-world evidence generation.
- Ensure high-quality benefit–risk assessments, safety evaluations, and clinical components of regulatory submissions.
- Provide strategic leadership for global medical affairs (scientific communications, publications, congress strategy, evidence generation, external engagement).
- Chair the Marketed Products Clinical Review Board; represent in scientific governance forums (e.g., Safety Board, labeling oversight).
- Partner with Patient Safety & Pharmacovigilance, Regulatory Affairs, Clinical Operations, Statistics, Global Project Management, and Business Units/Commercial to resolve complex issues.
- Ensure transition of assets from R&D Therapeutic Area Units and Global Medical Therapeutic Areas into Marketed Products Medical & Development.
- Lead talent development, succession planning, and organizational capability building.
- Represent the company externally with health authorities, KOLs, patient advocacy groups, and scientific organizations.
- Collaborate with Legal/Compliance/Regulatory to ensure proper and ethical external interactions.
- Lead application of AI tools and internal digital platforms to streamline processes, enhance quality, and speed.
EDUCATION (Required/Preferred)
- MD required; PhD or equivalent advanced scientific degree strongly preferred.
QUALIFICATIONS / REQUIRED
- Extensive experience in clinical development and medical affairs in the pharmaceutical/biotechnology industry.
- Track record leading, managing, and developing globally dispersed teams; strong talent judgment.
- Deep understanding of global regulatory, safety, and post-marketing requirements.
QUALIFICATIONS / PREFERRED
- Experience in multiple therapeutic areas, including oncology.
KEY SKILLS
- Ability to influence senior governance bodies and cross-functional leadership; ability to influence/negotiation outside the organization.
- Track record building high-performing, diverse, inclusive global teams.
- Stays current on emerging technologies and AI; leverages digital tools to improve productivity/efficiency.
- Strong leadership, communication (verbal and written), and ability to distill complex issues.
- Decision-making accountability for Clinical Science/Medical Affairs; seeks diverse input and implements feedback swiftly.
ADDITIONAL INFORMATION
- Travel up to ~30–40%.
Application instructions
- By clicking the “Apply” button, the employment application process commences and information is processed per Takeda’s Privacy Notice and Terms of Use.
- Provide global end-to-end medical and clinical science strategic leadership for marketed products, integrating post-approval clinical development, post-marketing commitments, and medical affairs.
- Ensure robust scientific, clinical, and medical oversight across the product lifecycle to safeguard benefit–risk, patient safety, and global regulatory compliance.
- Lead and develop a global organization of physicians, medical affairs leaders, and scientific directors.
- Senior medical/clinical leader for marketed products, partnering with R&D, Regulatory, Safety, Strategy & Portfolio Division, and Commercial Business Units.
- Core member of Marketed Products Medical & Development Leadership Team and chair the Clinical Review Board for marketed products.
ACCOUNTABILITIES
- Global strategic oversight for clinical science and medical affairs for a marketed products portfolio (post-marketing clinical development, lifecycle management, and medical affairs activities).
- Lead the global clinical science and medical affairs organization; ensure scientific rigor and medical governance; contribute strategically to GPTs, CSTs, and MSTs.
- Oversee clinical development plans, post-marketing commitments, Phase IIIb/IV studies, registries, and real-world evidence generation.
- Ensure high-quality benefit–risk assessments, safety evaluations, and clinical components of regulatory submissions.
- Provide strategic leadership for global medical affairs (scientific communications, publications, congress strategy, evidence generation, external engagement).
- Chair the Marketed Products Clinical Review Board; represent in scientific governance forums (e.g., Safety Board, labeling oversight).
- Partner with Patient Safety & Pharmacovigilance, Regulatory Affairs, Clinical Operations, Statistics, Global Project Management, and Business Units/Commercial to resolve complex issues.
- Ensure transition of assets from R&D Therapeutic Area Units and Global Medical Therapeutic Areas into Marketed Products Medical & Development.
- Lead talent development, succession planning, and organizational capability building.
- Represent the company externally with health authorities, KOLs, patient advocacy groups, and scientific organizations.
- Collaborate with Legal/Compliance/Regulatory to ensure proper and ethical external interactions.
- Lead application of AI tools and internal digital platforms to streamline processes, enhance quality, and speed.
EDUCATION (Required/Preferred)
- MD required; PhD or equivalent advanced scientific degree strongly preferred.
QUALIFICATIONS / REQUIRED
- Extensive experience in clinical development and medical affairs in the pharmaceutical/biotechnology industry.
- Track record leading, managing, and developing globally dispersed teams; strong talent judgment.
- Deep understanding of global regulatory, safety, and post-marketing requirements.
QUALIFICATIONS / PREFERRED
- Experience in multiple therapeutic areas, including oncology.
KEY SKILLS
- Ability to influence senior governance bodies and cross-functional leadership; ability to influence/negotiation outside the organization.
- Track record building high-performing, diverse, inclusive global teams.
- Stays current on emerging technologies and AI; leverages digital tools to improve productivity/efficiency.
- Strong leadership, communication (verbal and written), and ability to distill complex issues.
- Decision-making accountability for Clinical Science/Medical Affairs; seeks diverse input and implements feedback swiftly.
ADDITIONAL INFORMATION
- Travel up to ~30–40%.
Application instructions
- By clicking the “Apply” button, the employment application process commences and information is processed per Takeda’s Privacy Notice and Terms of Use.