Director/Senior Director, Clinical Pharmacology
Boundless Bio
Boundless Bio is a clinical stage, next generation precision oncology company addressing oncogene amplified cancers by targeting extrachromosomal DNA (ecDNA). We are seeking a Senior Director, Clinical Pharmacology to lead and provide strategic guidance to functional team and senior leadership to advance novel ecDNA candidates into transformative therapies to treat patients with oncogene amplified driven cancers.
Duties and Responsibilities:
Clinical:
- Lead and execute the strategy, planning, and design of clinical pharmacology studies.
- Provide scientific input into protocol development and into the pharmacokinetic endpoints for clinical trials.
- Responsible for the study design, analysis, interpretation, and reporting of clinical pharmacology data.
- Collaborate with internal Boundless teams, stakeholders, and CROs/consultants to ensure compliance with protocols, quality standards, and timelines.
- Support DMPK and clinical pharmacology components of preclinical and clinical study design, protocol development, data analysis and reporting.
Preclinical:
- Author high quality documents and review relevant clinical sections for IND and other regulatory submissions.
- Collaborate with preclinical scientists to provide support for translational studies.
In addition, this individual may manage and lead 1-2 direct reports and present data internally to senior leadership and to external stakeholders as required. Candidate will manage external CRO resources and perform all duties in keeping with Boundless Bio’s core values, policies, and all applicable regulations.
Education/Experience:
- PhD or Pharm D with 10+ years of relevant industry experience in clinical pharmacology.
- Deep understanding and experience in oncology drug development from pre – IND through early and late phase clinical development.
- Extensive small molecule experience in Oncology is a plus.
- Proven experience using expedient problem-solving skills with sound judgment.
- Successful track record of effectively collaborating and fostering high performance teams.
- Independent self-starter with the ability to drive execution within tight timelines.
- Outstanding written and verbal presentation skills.
Boundless Bio fosters an inclusive company culture that values diverse talent, backgrounds, and experiences. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.