Senior Medical Director, Oncology, Marketed Products Medical and Development

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 provides 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.

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, Delivering Priorities, Elevate Capabilities, Inspiring Others.
• Lead the application of appropriate AI tools, internal digital platforms and new technological skills to enhance the efficiency of Clinical Science (CS) related activities.
• Collaborate closely with DD&T related functions to combine clinical science expertise with new technology expertise to develop innovative approaches for rapid evaluation and reporting of clinical trial data.
• Forms integrated partnerships and works 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.
• Partner with Global Project Management (GPM) to coordinate R&D functional support for assigned products within the GPT or PST.
• Establish integrated partnerships 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 Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Evidence Generation/GEO/HEOR, Global Commercial, LOC MDs, Regional Business Units 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.
• 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 aforementioned)
• Training and experience in Oncology disease area (hematologic and/or solid tumor malignancies) required