Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an EVP/Vice President, Neuroscience Phase I and Gene Therapy Unit Group Leader, Clinical Science in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
- The NS Early Development and Gene Therapy Group Leader leads and drives the clinical strategy for all Phase 1 projects across the Neuroscience (NS) portfolio and for NS TAU gene therapy projects taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds.
- Leads a multi-disciplinary, multi-regional, matrix teams through highly complex decisions.
- This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute Phase 1 development plans that will result in efficient early derisking of pipeline compounds as well as any Phase 1 studies required for regulatory approval of the assigned compound in multiple regions.
- Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences GPTs and NS TAU senior leadership decision-making for the projects by setting strategic direction.
- Clinical participation and leadership
- Establishes and leads Global clinical Phase 1 strategy for all Phase 1 projects across the Neuroscience (NS) portfolio and the overall clinical development strategy for NS TAU gene therapy projects
- Deliverables include shaping the NS early and gene therapy Development Strategies, Phase 1 and gene therapy Clinical Development Plans and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Working with GPTs, drives the clinical science activities relating to the preparation / approval of Phase 1 and all phases of gene therapy synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Trial Medical Monitoring
- Responsible for ensuring robust Phase 1 medical monitoring plans, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
- Makes decisions regarding study conduct related to scientific integrity.
- External Interactions
- Key leader in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable for the successful completion of related objectives.
Due Diligence, Business Development and Alliance Projects
- Contributes to the identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, 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 DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
- May serve as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda s strategic goals while striving to maintain good working relationship between Takeda and partner.
Leadership, Task Force Participation, Upper Management Accountability
- Member of TAU leadership team and contributes to NS TAU strategy. May represent clinical science on multidisciplinary task forces across divisions. Lead global cross-functional teams, as appropriate.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
CORE ELEMENTS RELATED TO THIS ROLE
- The NS Phase I and Gene Therapy Unit Group Leader provides overall leadership to the Phase 1 plans and studies across the portfolio, in particular ensuring the technical excellence and subject safety in first-in-human trials. This role includes the full scope of people management tasks. The NS Phase I and Gene Therapy Unit Group Leader contributes to portfolio-level strategy. He/she is responsible for planning and executing towards future departmental needs. The NS Phase I and Gene Therapy Unit Group Leader works fully autonomously, contributes to designing new cross-functional processes, is frequently involved in evaluation of Business Development opportunities and works well and may lead interactions with external partners. He/she is expected to contribute the overall performance of Takeda R&D.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus 10 years of clinical pharmacology and early phase NS research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Previous experience successfully leading clinical development team/matrix teams with responsibility for studies in multiple regions.
- Deep IND/CTA experience and NDA/MAA/Submission experience preferred.
- Management experience
- 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
- Therapeutic area knowledge relevant to mechanism of action
- Regional/global Regulatory requirements
- Emerging research in designated therapeutic area
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 15 - 25% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
Empowering Our People to Shine
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit
Learn more at takedajobs.com.
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