BioSpace
Executive Medical Director, Oncology Clinical Sciences
BioSpace, Boston, Massachusetts, us, 02298
Executive Medical Director, Oncology Clinical Sciences
BioSpace
invites you to apply for this executive role in our Cambridge office. We are a patient‑focused, innovation‑driven company committed to delivering better health and a brighter future.
Responsibilities
Ensure ongoing review and agreement of the Therapy Area Strategy and related documents, vetted by appropriate governance committees.
Oversee the development and execution of the Integrated Disease Area Strategy (IDAS) and the Integrated Global Development Plan (IGDP).
Review clinical study documents and critical study results; provide leadership and oversight of the clinical development activity.
Provide guidance to TA leaders on regional specifics within the therapeutic area.
Lead the Global Development Team (US, EU, Japan/China) for assigned compounds, ensuring proactive risk mitigation.
Direct development strategy, deliverables, and protocols, maintaining compliance with regulatory requirements.
Make high‑impact global decisions, interpreting data from studies and recommending go/no‑go decisions or development plan modifications.
Ensure regional strategies and trade‑offs are well articulated in global strategy documentation and stakeholders are appropriately briefed.
Provide strategic input into global development strategies for all compounds in OTAU.
Support evaluation of external compounds (alliances and in‑licensing opportunities).
Collaborate with Medical Affairs, Clinical Operations, and Project Management for study planning and implementation.
Participate in critical review of synopses, protocols, and clinical documents via the Clinical Review Board.
Assess overall safety information in collaboration with pharmacovigilance.
Lead interactions with FDA, other regulatory agencies, and key opinion leaders.
Communicate with external partners and drive business‑development opportunities.
Interact with the research division and prioritize projects within the therapeutic area.
Hire, manage, mentor, motivate, and develop staff; conduct performance reviews and set goals.
Qualifications
MD or combined MD/PhD or internationally recognized equivalent with a minimum of 10 years in pharmaceutical research, including at least 7 years in phases I‑IV clinical development.
Experience in hematology and/or medical oncology, especially hematologic malignancies.
Proven leadership of a clinical development team across multiple regions.
Experience with NDA/MAA submissions.
Strong communication, strategic, interpersonal, and negotiation skills.
Ability to predict issues, solve problems, and drive decisions within a multi‑disciplinary, multi‑regional matrix.
Diplomatic and positive influencing abilities across multinational business cultures.
Travel Requirements
Willingness to travel internationally, including overnight stays; expected 25% travel.
Location Boston, MA (Cambridge office)
Compensation and Benefits Estimated U.S. base salary range: $X–$Y (subject to qualifications). Eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, paid volunteer time, and additional benefits.
EEO Statement Takeda is proud of 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 or expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, veteran status, or other protected categories, in accordance with all applicable laws.
Additional Information This position is classified as “hybrid” per Takeda’s Hybrid and Remote Work policy.
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invites you to apply for this executive role in our Cambridge office. We are a patient‑focused, innovation‑driven company committed to delivering better health and a brighter future.
Responsibilities
Ensure ongoing review and agreement of the Therapy Area Strategy and related documents, vetted by appropriate governance committees.
Oversee the development and execution of the Integrated Disease Area Strategy (IDAS) and the Integrated Global Development Plan (IGDP).
Review clinical study documents and critical study results; provide leadership and oversight of the clinical development activity.
Provide guidance to TA leaders on regional specifics within the therapeutic area.
Lead the Global Development Team (US, EU, Japan/China) for assigned compounds, ensuring proactive risk mitigation.
Direct development strategy, deliverables, and protocols, maintaining compliance with regulatory requirements.
Make high‑impact global decisions, interpreting data from studies and recommending go/no‑go decisions or development plan modifications.
Ensure regional strategies and trade‑offs are well articulated in global strategy documentation and stakeholders are appropriately briefed.
Provide strategic input into global development strategies for all compounds in OTAU.
Support evaluation of external compounds (alliances and in‑licensing opportunities).
Collaborate with Medical Affairs, Clinical Operations, and Project Management for study planning and implementation.
Participate in critical review of synopses, protocols, and clinical documents via the Clinical Review Board.
Assess overall safety information in collaboration with pharmacovigilance.
Lead interactions with FDA, other regulatory agencies, and key opinion leaders.
Communicate with external partners and drive business‑development opportunities.
Interact with the research division and prioritize projects within the therapeutic area.
Hire, manage, mentor, motivate, and develop staff; conduct performance reviews and set goals.
Qualifications
MD or combined MD/PhD or internationally recognized equivalent with a minimum of 10 years in pharmaceutical research, including at least 7 years in phases I‑IV clinical development.
Experience in hematology and/or medical oncology, especially hematologic malignancies.
Proven leadership of a clinical development team across multiple regions.
Experience with NDA/MAA submissions.
Strong communication, strategic, interpersonal, and negotiation skills.
Ability to predict issues, solve problems, and drive decisions within a multi‑disciplinary, multi‑regional matrix.
Diplomatic and positive influencing abilities across multinational business cultures.
Travel Requirements
Willingness to travel internationally, including overnight stays; expected 25% travel.
Location Boston, MA (Cambridge office)
Compensation and Benefits Estimated U.S. base salary range: $X–$Y (subject to qualifications). Eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, paid volunteer time, and additional benefits.
EEO Statement Takeda is proud of 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 or expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, veteran status, or other protected categories, in accordance with all applicable laws.
Additional Information This position is classified as “hybrid” per Takeda’s Hybrid and Remote Work policy.
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