The Senior Medical Director, Gene & Cell Therapy & Translational Engine provides overall leadership to gene and cell therapy studies across the portfolio. The Senior Medical Director, Gene & Cell Therapy & Translational Engine contributes to portfolio-level strategy. He/she is responsible for planning and executing towards future departmental needs. The Senior Medical Director, Gene & Cell Therapy & Translational Engine works fully autonomously, contributes to designing new cross-functional processes, coordinates strategies and expertise across therapeutic and disease areas, is frequently involved in evaluation of Business Develpment opportunities and works well and may lead interactions with external partners. He/she is expected to contribute the overall performance of Takeda R&D.
- The Senior Medical Director, Gene & Cell Therapy & Translational Engine leads and drives the clinical strategy for new gene and cell therapy projects across the Rare Diseases portfolio taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds.
- This individual provides input into the creation and execution of Phase 1 through Phase 3 clinical development and translational plans, assessing and integrating the development decisions from various research and business functions.
- As part of the Rare Diseases Gene Therapy center of excellence, applies clinical/medical decision making to clinical development issues and influences GPTs and Rare Diseases TAU senior leadership decision-making bodies in the development and execution of gene therapy strategies across the Rare Disease TAU.
- Serves as the subject matter expert in assessing external Gene and Cell therapy technologies and in the evaluation of business development opportunities to support the R&D portfolio and TAU strategy
- Provides strategic clinical input into hematology programs in the Rare Diseases TAU, working with the global project teams as they develop and execute on their programs.
- Clinical participation and leadership
- Establishes and leads strategy for new Gene and Cell Therapy projects across the Rare Disease portfolio
- Deliverables include shaping the Rare Disease gene and cell therapy Development Strategies and include the generation of Clinical Development Plans and Clinical Protocols for new indications. 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 and technical developments, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for input into high impact global decisions related to 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 for New Gene and Cell Therapy Programs
- Working with GPLs and their GPTs, drives the clinical science activities relating to the preparation / approval of of new gene and cell therapy program synopses, protocols and study reports. Serves as an advisor to other clinical scientists and medical directors involved in these activities.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Responsible for ensuring robust medical monitoring plans, assessing issues related to protocol conduct and/or individual subject safety of new projects. 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.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus at least 3 years of specialized clinical experience and at least 3 years of clinical development experience in hematology and/or gene therapy within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned).
- Previous experience successfully leading clinical development team/matrix teams with responsibility for studies in multiple regions.
- Deep gene/cell therapy 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 expertise (Hematology) preferred
- 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 25% travel.
- Availability to participate in early or late meetings/teleconferences
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.