Senior Medical Director, Oncology, Marketed Products Medical and Development
Boston, Massachusetts Job ID R0192420 Category Clinical Development Subcategory Research & Development Business Unit Global Portfolio Division Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the Role:
The Senior Medical Director (SMD) in Global Clinical Science and Medical Affairs, Marketed Products Medical and Development (MPMD) in Global Medical leads and drives the scientific strategy for the overall global clinical development of marketed products taking into consideration the medical, scientific, regulatory and life-cycle issues. Usually responsible for multiple products and at least one complex product.
The SMD interacts and partners with MPMD Global Program Leads (GPLs), Global Project Managers (GPMs) R&D function subject matter experts (SMEs), such as regulatory affairs, patient safety and pharmacovigilance, global development operations, to set clinical development strategy and priorities for assigned programs in MPMD. This individual is responsible clinical scientific leadership for the assigned product specific global program teams (GPT) and/or PST.
The SMD provides Medical Sponsor Oversight for clinical development programs in MPMD as part of the dedicated support to ensure the ability of Takeda to meet its corporate obligations as MAH for assigned products. The SMD provides clinical and scientific leadership to ensure that the GPT and Clinical Sub Team (CST) anticipates potential compliance risks and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
The SMD will be required to be the clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, clinical, and regulatory aspects of the products in order to provide support, guidance, mentoring and leadership across these areas.
How You Will Contribute:
Clinical Development Responsibilities and Leadership
- Execute responsibilities in MPMD and undertake product lifecycle decisions based on Takeda’s PTRB framework (Patients, Trust, Reputation, Business), balancing patient needs, scientific integrity, stakeholder trust, corporate reputation, and business value to optimize outcomes across marketed products.
- Provide strategic leadership to GPTs, PSTs and/or CSTs through demonstration of Takeda’s Leadership Behaviors during clinical development of marketed products:
- Strategic Thinking: Shape innovative clinical and scientific strategies by anticipating healthcare trends to maximize patient and business impact.
- Delivering Priorities: Drive cross-functional execution of key scientific objectives, ensuring timely, high-quality outcomes aligned with organizational priorities and goals.
- Elevate Capabilities: Advance team excellence through innovation, continuous learning, and knowledge sharing.
- Inspiring Others: Influence and motivate diverse stakeholders through collaboration, clear communication, and a patient-focused approach.
- Lead the application of appropriate AI tools, internal digital platforms and new technological skills to enhance the efficiency of Clinical Science (CS) related activities. Explore and experiment with new ideas to stay ahead in the rapidly evolving field of technology, especially those most relevant to CS responsibilities. Collaborate closely with DD&T related functions to combine clinical science expertise with new technology expertise in the organization to develop innovative approaches for rapid evaluation and reporting of clinical trial data to facilitate quick and robust decision making to bring value to patients and the organization.
- Forms integrated partnerships and work with Global Program Leaders (GPL) and Global Project management (GPM) and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across assigned products. Works effectively to support GPT/PST program goals, MPMD goals and Global Medical and corporate KPIs, as applicable.
- Partner with Global Project Management (GPM) to coordinate R&D functional support for assigned products within the GPT or PST. Provide clinical scientific leadership, expertise and execution for assigned products to support other R&D functional leads within the team.
- Establish integrated partnership(s) with R&D functional leads (e,g. regulatory affairs, patient safety & pharmacovigilance, global development operations, Statistics, QCP) on assigned team to achieve alignment on strategy and achieve program team goals.
- Partner with Center for Post Approval Safety Studies team members, during execution of PASS related responsibilities to achieve strategic alignment and to assure adherence to compliance.
- Collaborates with the commercial organization, including MCE, OBU, IBU and USBU, as well as relevant Sub-Teams to achieve team objectives. Also work directly with LOCs when required.
- Establish integrated partnerships and collaboration with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Evidence Generation/GEO/HEOR, Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
- Drives clinical scientific activities relating to the preparation/approval of synopses and protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed. Provides Takeda oversight of strategic partner MDs/clinical staff involved in these activities. Accountable for the successful design, execution and interpretation of clinical studies.
- Establish integrated partnership with clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
- Establish integrated partnership with strategic vendor partners and provide oversight of all strategic vendor partner for all clinical deliverables for assigned products. Ensure highest quality of clinical science input and clinical components of deliverables from the strategic vendor partner.
- Oversee the strategic vendor partner(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, protecting the safety of patients within the study. Responsible for internal oversight of strategic vendor partner medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Patient Safety and Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity.
- Presents study conclusions to senior leadership and determine how individual study results impact the product strategy. Interprets data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients.
- Participate in and support all required regulatory submissions/interactions for assigned products. Represent Takeda as Responsible Medical Doctor and Medical/Clinical expert to regulatory agencies globally for assigned products as needed. Support Local Operating Company (LOC) medical staff for all regulatory agency interactions as needed. Drive medical and clinical scientific input and development of required documents for regulatory applications/submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
- Participates in cross functional non-project-specific initiatives and committees on behalf of Global Clinical Science and Medical Affairs in MPMD to provide clinical & scientific leadership and perspectives.
- Provide scientific education and mentoring for internal and external audiences (academic partners, scientific community)
- Oversee compliance with internal SOPs and external legal requirements, including training of personnel, contractual arrangements with external service providers and partner companies.
External Interactions
- Build and develop medical and clinical expert relationships to ensure delivery and maintenance of state-of-the-art medical therapeutic and clinical scientific expertise for assigned marketed products.
- Represents Takeda's Clinical development opinion at regulatory meetings responding to the regulator’s' requests
- Represent Takeda on external bodies as needed.
Due Diligence, Business Development & Alliance Projects
- Participate, conduct and oversee clinical due diligence evaluations and development of clinical development plans for potential alliances and or in-licensing opportunities.
- Assess both scientific and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during due diligence visits and alliance negotiations, and actively participating on internal assessment teams in conjunction with commercial colleagues.
Preferred Qualifications:
- MD or internationally recognized equivalent
- 8+ years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Training and experience in Oncology disease area (hematologic and/or solid tumor malignancies) required.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MAU.S. Base Salary Range:
$257,600.00 - $404,800.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
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.
Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
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