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Senior Medical Director, Clinical Science -Solid Tumor
Senior Medical Director, Clinical Science -Solid TumorBioSpace • Boston, MA, United States
Senior Medical Director, Clinical Science -Solid Tumor

Senior Medical Director, Clinical Science -Solid Tumor

BioSpace • Boston, MA, United States
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Senior Medical Director, Clinical Science - Solid Tumor

Are you looking for a patient‑focused, innovation‑driven company that will inspire you and empower you to shine? Join us as a Senior Medical Director, Solid Tumor in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D‑driven market leadership and being a values‑led company. We empower our people to realize their potential through life‑changing work, offer stimulating careers, encourage innovation, and strive for excellence. We foster an inclusive, collaborative workplace united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Objectives

The Senior Medical Director leads and drives strategy for the overall global (US / EU / Japan) clinical development, integrating medical, scientific, regulatory, and commercial issues for multiple Takeda pipeline compounds. They lead a multidisciplinary, multi‑regional, matrix team through highly complex decisions, ensuring that the development plan secures regulatory approval across regions. Their clinical / medical decision‑making influences senior leadership direction and directly impacts Takeda’s commercial success.

Accountabilities

Clinical Development team participation and leadership

  • Leads the Global Development Team (US, EU, Japan) and manages the US / EU and Japan Development teams for assigned compounds.
  • Directs Development Team strategy, overseeing the Development Strategy, Clinical Development Plan, and Clinical Protocols, recommending scope, complexity, and budget.
  • Responsible for high‑impact global decisions : monitoring data, making “go / no‑go” and design modifications that affect timelines and product labeling.

Synopsis / Protocol Development, Study Execution, & Study Interpretation

  • Drives all Clinical Science activities related to Synopses, Protocols, and study conduct, ensuring successful completion of projects.
  • Interprets data from a scientific and medical perspective.

    • Trial Medical Monitoring

  • Oversees medical monitoring activities, assessing protocol conduct and subject safety, in partnership with Pharmacovigilance.

    • External Interactions

  • Directs interactions with regulatory authorities and key opinion leaders, advising clinical scientists and delivering results to senior leadership.

    • Due Diligence, Business Development and Alliance Projects

  • Identifies and evaluates potential business development opportunities, conducts due diligence, and negotiates clinical development plans for alliances or in‑licensing.
  • Serves as liaison for ongoing alliance projects, maintaining relationships and guiding clinical scientists.

    • Leadership, Task Force Participation, Upper Management Accountability

  • Collaborates with research divisions and TPNA / TPEU on clinical and development expertise, representing clinical science on task forces.
  • Hires, mentors, and develops staff, conducts performance reviews, and drives goal setting.

    • Education, Experience, Knowledge And Skills

  • MD or internationally recognized equivalent plus 7 years of clinical research experience in pharma, CRO, consulting, or academia, including 3‑4 years of late‑phase development.
  • Training and experience in hematology / oncology and / or medical oncology, especially solid tumor malignancies (preferred).
  • Experience in conducting or leading trials involving immune‑based therapies and / or antibody drug conjugates (preferred).
  • Previous experience leading a clinical development matrix team with multi‑regional responsibilities; experience beyond US / EU is a plus.
  • NDA / MAA / Submission experience preferred.
  • Excellent communication and influencing skills to engage stakeholders at all levels, including executive management and external partners.
  • Demonstrated ability to lead highly trained medical, scientific, and technical professionals.

    • Skills

  • Superior communication, strategic, interpersonal, and negotiating skills.
  • Proactive issue prediction and problem solving.
  • Decision‑making within multi‑disciplinary, multi‑regional, matrix teams.
  • Diplomacy and positive influencing across multinational business cultures.

    • Knowledge

  • Therapeutic area knowledge relevant to mechanisms of action of compounds in remit.
  • Regional / global regulatory requirements.
  • GCP / ICH.
  • Emerging research in the designated therapeutic area.

    • Travel Requirements

  • Ability to travel to various meetings or client sites, including overnight trips; some international travel may be required.
  • Approximately 15‑25% travel required.

    • Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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