Position
We are seeking an experienced leader to head the Clinical Scientist functional team within Clinical Development Operations, supporting Clinical Research & Development. The Clinical Scientist will lead the scientific planning and collaborate with both Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership & people management, technical skills, and scientific acumen as part of a cross-functional clinical development team. 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. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
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 the Clinical Scientist functional area, and specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
- 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, to effectively implement program development strategy
- 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)
- Prepare, coordinate, and participate in internal/external committee meetings (i.e., SMC, DMC)
- 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
- Post Graduate Degree with 10+ years or a Bachelor's degree with 12+ years
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- 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 authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports
- Adept ability to interact with key stakeholders across Clinical Research & Development functional areas
- Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals
- Adept ability to influence opinions and decisions of internal and external customers, across clinical development functional areas (e.g., Pharmacovigilance, Clinical Data Management, Clinical Research, Clinical Operations)
- Expert problem solving, prioritization, conflict resolution and critical thinking skills
- Strong communication, technical writing, and presentation skills experience
- Significant experience within oncology therapeutic area.
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