Clinical Scientist

We are adding to our Clinical Team and seeking a motivated and enthusiastic clinical scientist with experience in successfully executing on clinical programs in the oncology space.

 

Role and Responsibilities:

  • Accountable for the writing of clinical protocols and related documents in collaboration with the Medical Director. Will include managing the protocol development process and contributing to the medical/scientific input for the development of trial-related documents.
  • Participate in development of effective working relationships with key investigators to ensure optimal clinical study design, execution, and reporting. Contribute to trial-related advisory boards. Assist in protocol training meetings and investigator meetings.
  • Work with Clinical Operations to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: report study progress and issues with their resolution plan to Medical Director.
  • Lead in the process of reviewing, analyzing and interpreting of clinical trial data in collaboration with Medical Director. Includes the development of clinical trial reports, investigator brochures, publications and internal/external presentations.
  • Assist Clinical Operations in the development of clinical outsourcing specifications to facilitate bid templates and selection of CROs.
  • Contribute to the development of clinical sections of regulatory documents such as briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
  • Lead review of clinical trial documents such as statistical analysis plans, case report forms, etc.

 

Requirements:

  • Minimum of 5 years operational experience in planning, executing, and reporting clinical studies.
  • Advanced knowledge of Oncology and/or Hematology is strongly preferred.
  • Proven ability to work independently as well as to contribute to a multidisciplinary trial team.
  • Experience in developing effective relationships with key investigators and their staff.
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory processes.
  • Advanced degree or equivalent education; degree in life science/healthcare is strongly recommended; PharmD, PhD preferred.
  • Some travel required.

 

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Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.

We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.