Beacon Hill · 1 month ago
Clinical Scientist Director
Beacon Hill is a company focused on clinical development in oncology, and they are seeking a Clinical Scientist Director to contribute to early-stage oncology programs. The role involves developing clinical development concepts, drafting protocols, and supporting regulatory submissions while ensuring patient safety during clinical trials.
Staffing Agency
Responsibilities
Developing clinical development concepts and plans in collaboration with clinical leadership, with an emphasis on early oncology assets
Drafting protocol synopses, full study protocols, and protocol amendments
Preparing and reviewing informed consent forms and evaluating site‑specific ICF submissions
Partnering with Clinical Operations on site selection, study start‑up, and ongoing communication
Contributing to the creation and maintenance of clinical sections of investigator brochures, including coordinating initial versions and annual updates
Writing and/or reviewing clinical and safety content for regulatory submissions (e.g., global marketing applications)
Representing clinical/medical perspectives on study teams and supporting clinical leadership in strategic decision‑making
Participating in clinical sub‑team activities
Reviewing safety data, data listings, and serious adverse event information to support ongoing study evaluation
Contributing to or leading the authorship of clinical study reports and publications
Creating study‑ or program‑related presentation materials for internal and external audiences
Providing training to internal teams, CRO partners, and study site personnel on therapeutic area topics, program background, and study protocols
Supporting and participating in advisory boards and expert consultations
Conducting therapeutic area research, competitive landscape assessments, and indication‑specific analyses
Establishing and maintaining relationships with key investigators and thought leaders
Supporting interactions with global health authorities, including preparing responses to inspection findings and audit observations
Assisting with regulatory updates and submission‑related clinical deliverables
Supporting medical monitoring activities for Phase 2 or 3 clinical trials, ensuring patient safety and contributing guidance across study design, execution, and reporting
Presenting study outcomes to internal committees, external scientific groups, or advisory bodies; contributing to scientific congress presentations; and supporting publication activities
Authoring or reviewing clinical summaries, overviews, risk management materials, periodic safety updates, and labeling sections
Qualification
Required
Bachelor's degree with substantial clinical oncology expertise gained through prior clinical development experience
Minimum of 4 years of industry experience in oncology drug development
Prior involvement in clinical development programs, ideally across all study phases from initiation through reporting
Strong competency in protocol design, clinical data interpretation, and medical monitoring
Solid understanding of Good Clinical Practice (GCP) and regulatory expectations
Excellent written and verbal communication skills
Ability to work effectively in a fast‑paced, evolving environment
Preferred
Advanced degree or clinical qualification in oncology (e.g., Master's, MD, PharmD, PhD, or equivalent)
Experience working with small‑molecule oncology therapeutics is advantageous
Experience evaluating safety data and adverse events in therapeutic trials is preferred
Company
Beacon Hill
Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.
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 StageRecent News
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