Posted to MedZilla on 8/25/2019


Takeda Pharmaceuticals

US-MA, Medical Director - Oncology Therapeutic Area Unit R0008670-MZ


 
 

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Job Description

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
  • Skills
  • 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
  • Knowledge
  • Therapeutic area knowledge relevant to mechanisms of action of compounds in remit
  • Regional/global Regulatory requirements
  • GCP/ICH
  • 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.

TRAVEL REQUIREMENTS:

  • 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

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

http://www.takeda.us/careers/EEO_Policy_Statement.aspx

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

*LI-MH1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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