Director, Clinical Science

This key individual will report to the Sr. Medical Director, interface directly with multiple early development oncology teams, the CRO, and external sites/ investigators to lead clinical science activities and enable the Company to achieve a higher probability of success in developing novel anti-cancer therapeutics.

Responsibilities:

• Provide clinical science expertise and insights to the study teams.
• Lead/contribute to study design and protocol development in collaboration with internal and external stakeholders
• Develop and maintain clinical trial documentation (amendments, clinical study reports, investigator brochures, informed-consent forms, DSUR, etc.) in concert with the cross-functional team
• Collaborate with internal partners and CRO to develop and implement the overall data quality plan, lead and conduct internal medical data review and trend analysis, contribute to development of SAP, TLFs, eCRF design
• Curate clinical data and summarize findings to enable internal decision making
• Work closely with translational medicine to integrate mechanistic biomarker data and exploratory analysis with clinical data
• Provide scientific oversight and support during trial execution: data entry/reporting, protocol questions, site start-up and training, monitoring of key trial metrics, review and assessment of protocol deviations, risk-based quality oversight and study close-out
• Write and/or review abstracts, posters, develop content for scientific meetings, conferences, and other publicly distributed materials, and coordinate reviews with internal partners and stakeholders
• Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and interactions
• Collaborate with clinical operations and liaise with the clinical sites to facilitate patient enrollment and support resolution of issues that arise
• Enable a focus on the cancer patient

Requirements:

• ~5 years of experience working as a clinical scientist in the biotech/pharmaceutical industry in oncology space
• Strong understanding of clinical data: safety, efficacy, PK, PD
• Familiarity with regulatory requirements (FDA/ICH guidelines, GCP), safety reporting, and Good Clinical Practice
• The candidate should demonstrate a high level of independence, motivation, innovation, and excellent communication skills with team-oriented style, fast-paced, dynamic environment to facilitate exchanges within a matrixed organization
• Willing to travel (mostly domestic) occasionally, meet with investigators, attend conferences, participate in advisory boards, including over occasional weekends