Senior Director, Clinical Research & Development 2018-11-14T20:10:28+00:00


Senior Director, Clinical Research & Development

Job Summary

Cyteir is seeking an experienced and motivated hematologist/oncologist to lead our Phase I/II clinical trials as a key member of our growing development team.  This individual will be responsible for the clinical development strategy for our early clinical pipeline, for developing the protocols including case report forms and analysis plans, for supervising and medical monitoring of the studies, and for completing data analyses, reporting and publishing of the results. The Senior Director Clinical Research & Development will ensure that studies are completed on time and within budget in accordance with corporate objectives. The ideal candidate will have experience in completing phase I/II clinical trials in hematology or oncology and in working in a fast-paced, start-up biotech environment.

Job Responsibilities

  • Medical lead for clinical trials in hematology and oncology from candidate nomination (pre-IND) through proof-of-concept including:
  • Articulating the clinical development strategy.
  • Design, implementation, oversight and analysis of early stage clinical trials.
  • Clinical leadership on cross-functional early development project teams.
  • Close liaison with molecular diagnostics, translational and discovery scientists, and Development Teams for defining clinical PD or biomarker assays.
  • Participating in development of preclinical and translational strategies to support future clinical development, including combination testing.
  • Responsible for the creation of relevant clinical documents, including investigator brochure,protocols, clinical study reports, and regulatory submissions to ensure high quality and accuracy.
  • Responsible for clinical drug safety monitoring and management
  • Key resource for disease area expertise for the Development team.
  • Liaise with clinical and laboratory-based academic investigators in early oncology and be a focal point for defining and establishing relationships with key global phase 1 centers.
  • Part of the team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies for cost effective implementation of Cyteir’s R & D and early development strategy.
  • Contribute to the development and standardization of processes, procedures and infrastructure to support the clinical research needs of a growing organization.
  • Participate in formulating disease area strategy for target selection and validation.

Qualifications

  • M.D. PhD, 8 years relevant experience with a minimum of 5 years industry experience in Early/Translational Development. Subspecialty board certification in hematology/oncology preferred.
  • Experience in writing and executing sponsored phase I or II trials from protocol development to clinical study report.
  • Solid understanding of pharmacology and biomarker development
  • Proven record of building, leading and integrating cross-functional groups.
  • Track record in leading innovative efforts to deploy technologies and assays for enhanced translational capabilities.
  • Superior leadership, management and organizational skills, and a reputation as an open, available and transparent communicator.
  • Experience working in a fast-paced biotech environment.
  • Experience interacting and managing with regulatory and ethics authority submissions.
  • In depth understanding of GCP, ICH guidelines and FDA regulations
  • Understanding of IND & NDA regulations.
  • Proven track record of leadership and operational excellence required.
  • Ability to adapt to a lean organization,  and to embrace change and multi-task in an extremely fast-paced environment.
  • Excellent oral and written communications skills, and ability to influence across multiple functions.

Personal Profile

The Senior Director of Clinical Research & Development will be an energetic and team-oriented physician. with a history of executing early clinical trials with translational components. He or she will have the interpersonal skills required to collaborate and communicate effectively with a first-rate scientific team, playing a critical role in the clinical development of exciting new therapies in the treatment of cancer.

Working Conditions

This is a full time, office-based position in in Lexington, MA.  Travel (mostly US and some international) will be required up to 30%.

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Senior Director, Clinical Research & Development

  • Reports To: CEO/CMO
  • Department: Clinical R & D
  • Job Location: Lexington, MA
  • Base: Office
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