Job SummaryC4 Therapeutics is seeking a Director, Clinical Development Sciences, to provide clinical and scientific support on our clinical programs. In this role, you will work closely with Medical Directors, regulatory personnel, pre-clinical and translational program scientists, data managers, medical writers, program leads, project managers, biostatistics, and the clinical operations team in the successful execution of our clinical programs.
The C4T pipeline is currently focused on research and early clinical development. You will partner closely with the cross-functional teams in preparing regulatory documents, study start up, clinical trial conduct activities, data review/interpretation, and potential interactions with Health Authorities and play a key role in the advancement of our targeted protein degradation therapies.
Your Role- Provide input to the key research activities on a specific study or program, such as the design, conduct, analysis, and reporting of the clinical trials as well as study start up activities, training materials, site identification and visit
- Contribute to the development of the medical review plan, Independent Review Charter (IRC), and various program related documents
- Perform medical review, assessment, and interpretation of clinical trial data in collaboration with other functional groups throughout trial conduct and in the clinical study report (CSR) to ensure data accuracy and appropriate medical and scientific interpretation.
- Review and track emerging efficacy and safety and keep the study team informed of changes as they occur and take action as appropriate.
- Attend and contribute to study management team meetings, data management committee meetings, cross-functional data review meetings, clinical development team meetings, IND and pre-IND planning meetings, and regulatory submission planning meetings
- Assist in the design of electronic case report forms (eCRF), perform clinical user acceptance testing, and collaborate with data management and statistics in support of the development of the eCRFs and database set up
- Contribute to medical writing needs across a program including, but not limited to, Regulatory Briefing Books, protocol summary document, full protocol, Investigator Brochure updates, IND clinical sections and sections of clinical study reports and NDAs, responses to IRB's, health authorities and ethics committees.
- Ensure consistent practices with the highest ethical standards in compliance with GCP, internal SOPs, local regulations, and laws
Your BackgroundRequired:
- An advanced scientific degree (e.g. NP, PharmD, MS, MPH, PhD, DDS) or equivalent with a minimum of seven years of clinical research experience in clinical development within pharmaceutical/biotech industry, with a significant portion of this time focused on the development of oncology therapeutics
- An understanding of the drug development process from IND through NDA, including clinical study designs, data management, clinical operations, regulatory and medical writing
- Experience developing documents for FDA/regulatory review including but not limited to, briefing books, end of phase meetings, INDs and NDAs
- Knowledge of Good Clinical Practices (GCP) and regulatory requirements for the conduct of high-quality oncology clinical trials
- Proficiency in Microsoft Office suite, eCRF tools like Medidata Rave and data review tools like J-review
Preferred:
- Knowledge of preclinical and translational sciences
- Experience with heme-onc indications
- Experience in First in human clinical trials, protocol development, medical review, oversight of study conduct, running trials, key stakeholder engagement, data quality, and safety and/or medical writing
CompensationThe base pay range for this position at commencement of employment is expected to be between $221,935.00 and $245,295.00 annually; however, base pay offered may vary depending on multiple individualized factors, including job-related knowledge, skills, and experience.
