Qureos Mentor

Beacon Hill

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 What You&rsquo;ll Do
 
 
 
 In this role, you will contribute to the clinical development of early‑stage oncology programs and support studies across multiple phases. Responsibilities may include, but are not limited to:
 
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 Developing clinical development concepts and plans in collaboration with clinical leadership, with an emphasis on early oncology assets.
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 Drafting protocol synopses, full study protocols, and protocol amendments.
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 Preparing and reviewing informed consent forms and evaluating site‑specific ICF submissions.
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 Partnering with Clinical Operations on site selection, study start‑up, and ongoing communication.
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 Contributing to the creation and maintenance of clinical sections of investigator brochures, including coordinating initial versions and annual updates.
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 Writing and/or reviewing clinical and safety content for regulatory submissions (e.g., global marketing applications).
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 Representing clinical/medical perspectives on study teams and supporting clinical leadership in strategic decision‑making.
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 Participating in clinical sub‑team activities.
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 Reviewing safety data, data listings, and serious adverse event information to support ongoing study evaluation.
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 Contributing to or leading the authorship of clinical study reports and publications.
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 Creating study‑ or program‑related presentation materials for internal and external audiences.
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 Providing training to internal teams, CRO partners, and study site personnel on therapeutic area topics, program background, and study protocols.
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 Supporting and participating in advisory boards and expert consultations.
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 Conducting therapeutic area research, competitive landscape assessments, and indication‑specific analyses.
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 Establishing and maintaining relationships with key investigators and thought leaders.
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 Supporting interactions with global health authorities, including preparing responses to inspection findings and audit observations.
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 Assisting with regulatory updates and submission‑related clinical deliverables.
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 Supporting medical monitoring activities for Phase 2 or 3 clinical trials, ensuring patient safety and contributing guidance across study design, execution, and reporting.
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 Additional contributions may include presenting study outcomes to internal committees, external scientific groups, or advisory bodies; contributing to scientific congress presentations; and supporting publication activities. Program‑level responsibilities may involve authoring or reviewing clinical summaries, overviews, risk management materials, periodic safety updates, and labeling sections.
 
 
 
 Requirements
 
 
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 Bachelor&rsquo;s degree with substantial clinical oncology expertise gained through prior clinical development experience.
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 Advanced degree or clinical qualification in oncology (e.g., Master&rsquo;s, MD, PharmD, PhD, or equivalent) preferred.
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 Minimum of 4 years of industry experience in oncology drug development.
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 Prior involvement in clinical development programs, ideally across all study phases from initiation through reporting.
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 Experience working with small‑molecule oncology therapeutics is advantageous.
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 Strong competency in protocol design, clinical data interpretation, and medical monitoring.
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 Experience evaluating safety data and adverse events in therapeutic trials is preferred.
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 Solid understanding of Good Clinical Practice (GCP) and regulatory expectations.
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 Excellent written and verbal communication skills.
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 Ability to work effectively in a fast‑paced, evolving environment
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</div>

Clinical Scientist Director

Join Beacon Hill and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Beacon Hill

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Clinical Scientist Director