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Associate Director, Clinical Scientist
3 months ago
Associate Director, Clinical Scientist - Oncology
- Qualifications
- Master’s degree in life sciences + 3 years clinical drug development experience, or PhD, Pharm D, RN degree.
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
- Role requires a proactive approach, strategic thinking, and leadership in driving toward clinical study goals.
- Ability to manage multiple competing priorities with good planning, time management, and prioritization skills.
- Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
- Proficient scientific expertise to propose, design, and execute clinical research and development studies, and author documents related to clinical trials, such as medical monitoring plans, SAPs, informed consent, and clinical components of the Clinical Study Reports.
- Problem-solving, prioritization, conflict resolution, and critical thinking skills.
- Strong communication, technical writing, and presentation skills experience.
- Experience within oncology is preferred.
- Responsibilities
- Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s); including serving as the lead clinical scientist on the clinical trial team, leading medical monitoring team in review/ interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance.
- Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents/amendments); partnering with Clinical Operations on study deliverables
- Influence opinions and decisions of internal and external customers/vendors, across functional areas.
- Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming
- Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct
- Providing tactical/scientific mentorship to other clinical scientists
- Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)
- Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identify risks and design mitigation strategies
- Interact with key stakeholders across the Clinical Development functional area.
- Promotes consistent first-line medical/clinical data review techniques and conventions across studies/programs.
