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 a Medical Director in our Cambridge office.
Takeda is seeking a skilled physician to serve as clinical lead for global phase 2/3, registrational trials of NINLARO (ixazomib), in new indications for the treatment of multiple myeloma.
- Ixazomib represents a major advance in myeloma therapy, as the first oral proteasome inhibitor, having a favorable safety profile well tolerated and suitable for long-term administration, with a low treatment burden for patients.
- These trials are high priority for Takeda Oncology, with high expectations and a major investment by the company
- Six registrational ixazomib trials currently being conducted, five in multiple myeloma (including front-line, relapsed disease, and maintenance) and one in relapsed/refractory light chain amyloidosis.
- Additional phase 1,2 trials being conducted with ixazomib and other novel multiple myeloma agent combinations
- In partnership with the Clinical Operations lead, the physician will lead a multidisciplinary study team through all aspects of the trial, including study start-up, enrollment, interim analysis, stage-up to phase III, final analysis and submission of registration package.
- As the study medical lead, the physician will supervise the CRO medical monitors responsible for patient/site level medical management, conduct high-level data review, interact with sites and KOLs as needed, and provide tactical and strategic oversight of clinical trial progress.
- As a member of the ixazomib clinical development program in the Oncology Clinical Research department, the physician will be an active participant in progressing the overall ixazomib development program strategy.
- Additional duties and responsibilities will be commensurate with the physician s interest, experience and capacity.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- MD or internationally recognized equivalent plus 7 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).
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EU a plus.
- NDA/MAA/Submission experience preferred
- Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred
- 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
- Therapeutic area knowledge relevant to mechanisms of action of compounds in remit
- Regional/global Regulatory requirements
- Emerging research in designated therapeutic area
- Clinical trial experience necessary. Phase III trial experience desirable. Oncology experience necessary. Multiple myeloma or other hematologic oncology experience desirable.
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be 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
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