The Steely Group · 2 hours ago
Director, Clinical Science
Greater Boston
Full-time
Hybrid
Lead/Staff, Director/Executive
$235K/yr - $245K/yr
5+ years expThe Steely Group is focused on developing novel anti-cancer therapeutics, and they are seeking a Director of Clinical Science to lead clinical science activities. This role involves providing expertise, overseeing study design, and collaborating with various teams to ensure successful clinical trials.
ConsultingHealth CareHuman ResourcesMedicalStaffing Agency
Hiring Manager
Ryan Dietman
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
Qualification
Required
Graduate degree in health sciences: e.g. PhD, PharmD
~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
Company
The Steely Group
The Steely Group offers clinical, healthcare, and human resource recruitments and staffing solutions.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Giovanni Oriente
Chief Financial Officer
Jay VanHousen
Sr Director, Clinical and Scientific Partnerships
Recent News
2025-10-23
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