ASSOCIATE DIRECTOR, CLINICAL SCIENTIST
6mth initial contract (potential extension / conversion based on performance and need)
Hybrid - South San Francisco, New York, New Jersey (3 days onsite, non negotiable)
*Reason for the role - backfilling another individual that is unfortunately relocating.
Urgently seeking a seasonedClinical Scientist that will serve as a key role contributing to the scientific planning and collaborate with both Clinical Research, Pharmacovigilance and Clinical Operations in the execution of multiple global clinical trials.
You will be a key contributor in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results.
Currently an individual contributor, however may be opportunity to hire and develop future Clinical Scientists.
About You
You are a data driven and collaborative integrator that is passionate about driving development and execution of therapeutic strategy that enables innovative pipeline impact and delivery of transformative medicines to patients. You have exemplary communication and presentation skills and can lead study development by applying the most current electronic document conventions/processes consistently to ensure scientific and data integrity.
What You’ll Do
- Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s).
- Serving as the lead clinical scientist on the clinical trial team
- Leading medical monitoring team in review and 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
- 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; identifies risks and designs mitigation strategies
- Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs..
Qualifications
- PhD, PharmD or other Post Graduate Degree with min. 8+ years of relevant experience in clinical research.
- Experience within oncology required.
- Must have global trial experience incl. first in human and Phase I – III.
- Solid knowledge of clinical research regulatory requirements
- 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 authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports
- Interact with key stakeholders across Clinical Development functional areas
