Associate Director, Clinical Science
USFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 8+ years of pharmaceutical or biotech experience in clinical development
- Required Skills
- LeadershipAnalytical SkillsProblem SolvingMicrosoft OfficeCross-functional collaborationGoogle Workspace
Requirements
- Advanced degree in Life Sciences (MD, PhD, PharmD, MS, RN, or equivalent scientific discipline preferred).
- 8+ years of pharmaceutical or biotech experience in clinical development, with a strong focus on oncology clinical trials.
- Deep understanding of oncology, including molecular diagnostics, companion diagnostics, or early cancer detection (preferred).
- Proven experience in clinical protocol writing, data review, data cleaning, and interpretation of clinical trial results.
- Strong knowledge of FDA regulations, international regulatory frameworks, and Good Clinical Practice (GCP).
- Demonstrated ability to work effectively in cross-functional, matrixed environments.
- Experience supporting or managing direct reports, including hiring, training, and performance development.
- Strong analytical and problem-solving skills with the ability to translate complex data into clear insights.
- Excellent communication skills, including scientific writing, presentations, and stakeholder engagement.
- Ability to balance strategic thinking with detailed operational execution in a fast-paced environment.
- Strong organizational skills, adaptability, and ability to manage competing priorities effectively.
- Proficiency with Microsoft and Google productivity tools.
- Demonstrated leadership, influence, and collaboration skills across internal and external stakeholders.
Responsibilities
- Lead the development of clinical study concepts, including study design, objectives, endpoints, eligibility criteria, and schedules of assessment.
- Collaborate cross-functionally to develop and refine protocols, informed consent forms, and amendments, ensuring alignment with governance and clinical development teams.
- Provide protocol training, contribute to CRF design, and ensure consistency between study documentation and execution plans.
- Engage investigators, key opinion leaders, and study sites to support study design input, feasibility, and execution readiness.
- Oversee clinical trial execution activities, including real-time data review, CRO oversight, and issue resolution.
- Develop and maintain clinical execution timelines, providing regular updates and status reporting to senior leadership.
- Partner with data management and programming teams to develop data review plans and ensure high-quality data collection aligned with protocols.
- Support clinical operations through participation in advisory boards, investigator meetings, and scientific presentations.
- Contribute to clinical research strategy, including company-sponsored and investigator-initiated studies.
- Provide scientific input into clinical trial delivery, data interpretation, and regulatory submission support.
- Ensure compliance with HIPAA, GCP, and applicable regulatory standards across all clinical activities.
- Support organizational development by contributing to process improvements and mentoring junior clinical scientists where applicable.
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