Director Clinical Science
AD or Director Clinical Science
Watertown, MA - On-site
Compensation: $180,000-220,000 + bonus + equity
Company Summary:
Join a well‑capitalized, publicly traded precision‑oncology company that is redefining how cancer therapeutics are developed. The organization is built around a functional biology platform that moves beyond genomics to directly measure drug‑regulated pathway activity in tumors. Scientific, translational, and clinical strategy are deeply integrated, with biomarkers serving as a core design principle rather than an add‑on.
The company is led by seasoned physician‑scientists with a track record of advancing therapies through late‑stage development and regulatory approval. Backed by top‑tier investors, it maintains a multi‑year operating runway while still operating at a size where individual contributions meaningfully shape programs and strategy.
This is an opportunity for someone who thrives in intellectually engaged, high‑ownership settings, values scientific depth, and wants to work on programs with real clinical consequence, without the bureaucracy of larger organizations.
Responsibilities:
- Partner with the Clinical Development team to review, analyze, and interpret study data, ensuring high‑quality data review, accurate reporting, timely query resolution, and strong oversight of safety events, protocol deviations, samples, and study‑related documentation.
- Develop clear, compelling presentations of clinical results (e.g., waterfall, swimmer, spider plots) for internal leadership and external audiences.
- Maintain rigorous database quality and integrity, supporting data and sample tracking, reporting updates, regulatory responses, and adherence to GCP and internal standards.
- Work closely with the medical monitor to ensure timely communication of key study insights and emerging trends.
- Monitor ongoing study data to identify issues related to safety, efficacy, deviations, site performance, or data quality, and proactively drive resolution.
- Collaborate with clinical teams and CRO partners to design and implement solutions to study or program challenges.
- Conduct literature research to support data interpretation and continuous improvement of study workflows.
- Contribute to trial design and core study documents - including protocols, ICFs, CRFs, data review plans, SAPs, IRT specifications, data entry guidelines, and medical monitoring/risk‑management plans - in partnership with biostatistics, clinical pharmacology, translational medicine, clinical operations, and data management.
- Support the development of program documents such as pharmacy manuals, study procedure manuals, SOPs, safety/deviation tracking tools, and SIV materials.
- Assist in drafting clinical content for regulatory submissions, including INDs, study reports, investigator brochures, annual updates, and NDAs.
- Serve as the Clinical Science representative on cross‑functional teams as assigned.
Qualifications:
- Phd or PharmD
- 4 years + biotech/Pharma experience.
- Experience with Oncology Trials