Clinical-stage biotechnology company advancing precision oncology and next-generation cancer therapies.
Responsibilities
Collaborate with senior medical leaders, drug discovery teams, translational oncology specialists, clinical operations, investigators, and disease-area experts to develop and execute early clinical development strategies.
Design clinical trials that rigorously test translational hypotheses and establish clinical proof of concept.
Prepare clinical sections of key regulatory and development documents, including Investigator’s Brochures, IND summaries, and Clinical Trial Applications (CTAs).
Support responses to questions from regulatory authorities, IRBs, and ethics committees.
Review, assess, and interpret clinical data, translating findings into clear insights.
Manage drug safety and pharmacovigilance activities for ongoing clinical trials.
Participate in and support clinical site initiation visits.
Integrate new findings from internal and external clinical trials, translational research, and basic science into clinical development plans.
Work with research leadership and drug discovery teams to inform the broader drug discovery portfolio.
Build and maintain strong relationships with internal and external stakeholders.
Uphold rigorous standards of compliance, scientific integrity, and ethical conduct.
Requirements
MD, MD/PhD, or another relevant advanced degree.
Typically 5 or more years of clinical development experience in academic and/or industry settings, with a background in oncology.
Experience working with solid tumors; breast oncology experience preferred.
Familiarity with clinical trial design and execution, including protocol development, case report form design, and statistical analysis plans.
Experience collaborating with investigative sites.
Strong clinical judgment and ability to assess and interpret complex clinical data.
Excellent written and verbal communication skills.
Strong collaboration and interpersonal skills.
Adaptability and a proactive, solutions-oriented approach.
Commitment to scientific rigor, patient safety, ethical clinical research, and continuous learning.
Ability to work remotely within the United States.
Conditions
Estimated annual base salary: $213,000–$304,000, depending on experience, education, skills, and geographic location.
Remote work flexibility.
Opportunity to contribute to precision oncology therapies.
Exposure to innovative drug discovery approaches and early-stage clinical development programs.
Cross-functional collaboration with specialists across clinical medicine, translational science, drug discovery, regulatory affairs, and clinical operations.