Sr. Director, Clinical Research - Oncology
Job Type: Full-time
Salary: $275K - $350K
Location: Millbrae, CA / Jersey City, NJ / New York, NY (Hybrid)
Company Summary: A pre-IPO clinical stage biotech developing revolutionary therapies in the oncology & CNS spaces. Backed by VCs and led by exMerck-Keytruda leaders, they have successfully raised over a $1 billion continue advancing their clinical programs.
The Opportunity: Our client is seeking a seasoned physician with a strong clinical background and a passion for drug development to join our Clinical Development team where they will serve as the Senior Director, Clinical Research, Oncology. In this role, you will play a pivotal part in advancing our Oncology pipeline by providing medical expertise, strategic leadership, and operational oversight for multiple clinical development studies.
Responsibilities:
- Designing and conducting early-stage or late-stage clinical development trials, including, but not limited to: assessing clinical safety and efficacy data, performing medical monitoring, and performing clinical study related activities.
- Working closely with biomarker, discovery, and translational research scientists.
- Interpreting reports, preparing oral and written reports on research
- Collaborating closely with Clinical Science and other relevant functions and potential partners including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, regulatory representatives, as well as personnel from Global Clinical Operations, and other support functions.
- Establishing strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.
- Working closely with functional partners (Data Management, Clinical Operations, Biostatistics, Regulatory) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in clinical development in close collaboration with key functional stakeholders.
- Working in partnership with colleague study responsible physicians and clinical scientists to ensure development of high-quality study protocols including use of consistent processes/standards across studies.
- Work closely with functional partners to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
Requirements:
- MD or DO with significant experience in Oncology
- 5-7 years of clinical experience, including 3+ years in drug development
- Experience in clinical practice with direct patient care (preferably in Oncology)
- Experience with IND and/or NDA filings is preferred
- Medical monitoring of early and late stage clinical trials
Benefits:
- Pre-IPO employee stock program
- Health benefits (medical, dental, and vision)
- Competitive salary with comprehensive benefits and PTO
- 401K contribution
- Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide
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