Beacon Hill · 4 hours ago
Director of Clinical Sciences
United States
Full-time
Remote
Lead/Staff, Director/Executive
4+ years expBeacon Hill is seeking an experienced Clinical Scientist to work closely with the clinical leader in providing medical-scientific expertise for oncology projects. The Director will be responsible for writing clinical development plans, protocols, and ensuring compliance with health authority interactions while also supporting clinical trial activities.
Staffing Agency
Responsibilities
With the clinical leader, writing clinical development concepts and plans for molecules at all stages of development but more focused on early oncology development
Writing initial and or later drafts of protocol synopses, protocols and protocol amendments
Writing/reviewing informed consent forms and reviewing/adjudicating site-specific ICF requests
Partnering with Clinical Operations on site selection, start-up and communication
Writing or updating clinical sections of investigator brochures and leading the team that writes the initial brochure and subsequent annual updates
Writing/reviewing clinical/safety sections of NDAs/MAAs
Representing the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leader
Serving as a member of the clinical sub team
Reviewing and interpreting data listings including safety data and serious adverse events
Assisting with or serving as primary author of clinical study reports and associated publications
Creating clinical study- or program-related slide decks for internal and external use
Training of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriate
Organizing and participating in opinion leader advisory boards
Contributing to or performing therapeutic area/indication research and competitor analysis
Building and maintaining opinion leader/investigator networks
Support Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal audits
Support HA updates and submissions
Assist Medical Monitor for Phase 2 or 3 clinical trials, accountable to the clinical lead for patient safety and providing guidance during the design, execution, and reporting for clinical studies
Additional study level activities might include presentation of study results to internal and external committees or advisory boards, presentation of data at international scientific meetings and publication of study results in peer-reviewed journals
In addition to study level activities, the Director will participate in program level activities including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety updates and clinical sections of product labels
Qualification
Required
Bachelor's degree and strong knowledge of clinical oncology gained through previous clinical development experience are required
Postgraduate qualification in clinical oncology (e.g., Masters degree) would be welcomed as would MD, Nurse Practitioner's License, PharmD or PhD
At least 4 years of industry experience in oncology
Previous participation in a clinical development program is essential, preferably involvement in all stages of clinical trials (i.e., from start up to study report)
Skilled in protocol design, interpretation, and medical monitoring
Knowledge of Good Clinical Practice
Excellent written and oral communication
Capacity to adapt to a fast-paced and changing environment
Preferred
Experience in clinical trials with small molecules preferred
Experience in assessment of adverse events and safety of patients participating in therapeutic clinical trials is preferred
Company
Beacon Hill
Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.
1001-5000 employees
H1B Sponsorship
Beacon Hill has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (94)
2023 (76)
2022 (60)
2021 (77)
2020 (86)
Funding
Current Stage
Late StageLeadership Team
Amber Leslie
Executive Assistant to CEO
Amy Van Sicklin
Chief Culture Officer
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