Senior Medical Director, Clinical Science, Marketed Products Group, Oncology応募後で応募 求人ID R0065061 掲載日 04/20/2022 Location:Boston, Massachusetts
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Senior Medical Director, Clinical Science, Marketed Products Group, Oncology where you will be accountable for Medical Sponsor and Clinical oversight for assigned marketed products globally, and contributes to new business evaluation of marketed products. You will also be an integral member of a R&D Marketed Product Team (R&D MPT) that is responsible for providing dedicated R&D support for the products under its purview.
The MDMP interacts and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance, global development operations and project management) to set R&D strategy and priorities R&D functional support for assigned MP portfolio. This individual is responsible for medical and clinical scientific leadership for the assigned R&D Marketed Product Team (R&D MPT) and product specific global program teams (GPT) or established product teams (EPT) as required, The SMDMP provides Medical Sponsor Oversight for all products managed by the R&D MPT as part of the dedicated, integrated R&D support to ensure the ability of Takeda to meet its corporate obligations as MAH for assigned products. The MDMP provides medical and clinical leadership to make sure that the R&D MPT anticipates potential compliance risks, and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles. As part of the, you will report to the Head of Global Clinical Science, Marketed Products Group and work with the Marketed Products Group.
The SMDMP will be required to be the medical and clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products in order to provide medical, clinical and scientific support, guidance, mentoring and leadership across these areas.
How you will contribute:
- Partner with R&D Marketed Product Project Manager to coordinate R&D function support for assigned products within the R&D MPT. Provide medical and clinical scientific leadership and expertise for assigned products to support other R&D function leads within the R&D MPT.
- Establish integrated partnership(s) with R&D functional leads on assigned R&D MPT (regulatory affairs, pharmacovigilance, global development operations).
- Collaborates with the commercial organization and Established Products Teams and Sub Teams. Also works directly with LOCs when required
- Form integrated partnerships and collaborate 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), Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
- Forms integrated partnerships with and works with Global Product Team Leaders (GPL) and Established Product Team Lead (EPTL) as necessary, and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across assigned products. Ensure the R&D MPT works effectively to support GPT/EPTs.
- Forms integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor medical and clinical deliverables for all products in assigned R&D MPT. Ensure highest quality of medical/clinical science input and clinical components of deliverables from the strategic partner vendor.
- Sponsor supervision and guidance for vendor medical monitors
- Partners with strategic partner vendor(s) and drives medical and clinical scientific activities relating to the preparation / approval of 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.
- Oversees the strategic partner vendor(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 partner vendor 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 Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity
- Establish integrated partnership with strategic partner 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.
- Participates in cross functional non-project-specific initiatives and committees on behalf of project clinical perspective as well as general clinical science functional perspective.
- Presents study conclusions to management 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.
- Provide scientific education and mentoring for internal and external audiences (academic partners, scientific community, regulatory agencies)
- Oversee compliance with internal SOPs and external legal requirements, including training of personnel, contractual arrangements with external service providers and partner companies.
- Build and develop medical and clinical expert relationships to ensure delivery and maintenance of state-of-the-art medical therapeutic and clinical scientific expertise into medical and clinical R&D support for assigned marketed products
- Represents Takeda's Clinical development opinion at regulatory meetings responding the regulators' requests
- Represent Takeda on external bodies as needed.
- 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.
- MD or internationally recognized equivalent plus 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).
- Experience in oncology disease area required.
- Participation in NDA/MAA/Submission experience
- Track record and demonstrated ability to lead and manage both science and business aspects of drug development.
- Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities across multinational business cultures
- Emerging research in Translational Medicine
- Nonclinical and clinical drug discovery and development
- TMS state-of-the-art technologies
- Regional/global Regulatory requirements
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.