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.
- 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.
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.