Clinical Scientist Director

What You’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:

• 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.

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

• Bachelor’s degree with substantial clinical oncology expertise gained through prior clinical development experience.
• Advanced degree or clinical qualification in oncology (e.g., Master’s, MD, PharmD, PhD, or equivalent) preferred.
• 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.
• Experience working with small‑molecule oncology therapeutics is advantageous.
• Strong competency in protocol design, clinical data interpretation, and medical monitoring.
• Experience evaluating safety data and adverse events in therapeutic trials is preferred.
• 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