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 the Head of Translational and Clinical Sciences, Cell Therapies in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As the Head of Translational and Clinical Sciences leading Takeda s Cell Therapy Translational Engine, you will be empowered to establish and execute a global clinical strategy to support Takeda s emerging cell therapy pipeline, and a typical day will include:
The Head of Translational and Clinical Sciences, Cell Therapies will partner as needed with Takeda s existing clinical and related functional teams to advance multiple programs in to the clinic and through early development. As a senior member of Takeda s Cell Therapy Engine, you will be actively engaged in strategic oversight of the portfolio and accountable for both the vision and execution of our cell therapy pipeline.
- Develop and lead first-in-human and early clinical development plans for novel cell and gene therapies.
- Lead all clinical and medical related functions, whether internal or outsourced, including direct line and budget responsibility for clinical research, clinical operations, biostatistics, data management, safety/pharmacovigilance, and medical writing; responsible for resourcing and staffing decisions
- Set strategic plan and lead execution of GCP clinical trials with the goal to achieve regulatory approval by FDA and international health authorities, including overseeing clinical trial data analysis, interpretation and regulatory soundness
- Provide disease area and clinical development expertise in support overall Company strategy
- Oversee safety monitoring, adverse event reporting and required documentation of both to support regulatory submissions
- Lead pipeline prioritization strategy and implementation, in collaboration with senior leadership; ensure clinical drug candidates meet standards of safety, efficacy, medical need and commercial viability required for further development and commercialization
- Lead interactions with academic thought leaders, principal investigators and other key stakeholders; oversee site identification, appropriateness of patient populations and appropriateness of PI expertise to ensure trials are conducted safely, efficiently and effectively - serves as a resource to PI s regarding clinical trial activities and safety issues
- Collaborate with Regulatory Affairs on the submission of regulatory filings, including IND s, BLA s, orphan drug applications, and others, to FDA and international health authorities
- Collaborate with the Head of Cell Therapy Core, business development and research groups to identify and assess new product candidates; ensure clinical and commercial alignment; provide input on clinical feasibility of commercial objectives
- Collaborate with the Head of R&D to ensure pre-clinical and clinical alignment; and to report preclinical and clinical data at scientific and medical meetings and for publication in peer reviewed journals
- Collaborate with Cell Therapy Manufacturing and Quality groups on operational issues
- Represent the Company and its programs to internal and external audiences, including scientific meetings, regulatory agencies and KOLs
EDUCATION, EXPERIENCE AND SKILLS:
- M.D. / PhD +10 years of experience in Biopharmaceutical Clinical Research
- Understanding of immuno-oncology space ; experience working in the translational and clinical research space
- Experience bringing biological drug candidates from pre-IND through Phase I / II to BLA.
- Cross-functional leadership experience is required.
- Experience with Cell or Gene Therapy is preferred
Knowledge and Skills:
- Knowledge of GCP, ICH, FDA regulations and guidelines, including direct experience interacting with FDA and other international health authorities, is required.
- Proven leadership capabilities and excellent interpersonal skills ; proven ability to develop healthy culture including collaboration and confidence, both internally and externally
- Ability to lead in a matrixed team environment
- Exceptional verbal and written communication and presentation skills ; proven ability to communicate effectively to a range of audiences, including both internal and external collaborators and stakeholders
- Values efficient decision-making and regularly gathers input from team members at all levels ; demonstrated track record of effectively influencing decisions inside and outside of an organization, overcoming obstacles and driving efforts to completion
- Excellent strategic planning, organizational and creative problem-solving skills
- Board Certification in Hematology or Oncology is desirable
- Approximately 20% travel is required.
- Domestic and international flights with overnight stays required
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
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.