Director Clinical Science

Director Clinical Science

Northern New Jersey Area (Hybrid)

Salary: $200,000-230,000 Bonus Equity

Our client is a cutting edge CAR-T who novel approach dramatically decreases the time and cost associated with manufacturing. This is a newly created position allowing you to get in on the ground floor and eventually build a team beneath you as their indications advance in development. This company has received substantial funding through a highly successful serious B round of funding this past year where they generated over $200 million. They also have a leadership team with multiple approvals under their belt. If you are looking to be at the forefront of revolutionizing the CAR-T cell therapy space don't hesitate to apply and learn more!

Key Responsibilities:

• Offer scientific expertise during protocol development, study design, oversight of study conduct, and interpretation of study results through to the final study report.
• Collaborate with a multidisciplinary team including Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, Project Management, Medical Affairs, and CMC to achieve and deliver program objectives.
• Participate in protocol feasibility assessments, site identification, and vendor evaluation.
• Partner with Clinical Operations to review vendor, CRO, and site scope of work, study budget, and plans or manuals related to study data, IVRS, central labs, etc.
• Assist in the preparation of abstracts, manuscripts, presentations, and materials for external meetings related to the assigned protocol(s) and/or clinical program.
• Contribute to the writing of documents to support study conduct and regulatory submissions, including protocols, investigator brochures, informed consent forms, training documents, and clinical study reports; lead authorship for laboratory and pharmacy manuals.
• Develop and deliver internal and external training materials and presentations, including site initiation visits.
• Analyze potential safety and efficacy trends in clinical trial data for the preparation of interim and final reports of clinical trial data for study documents (including CSRs, IBs, and DSURs).
• Engage with academic partners, collaborators, advisory board members, etc., as appropriate.
• Support the planning and conduct of study committee meetings (e.g., IDSMC), investigator meetings, and advisory boards, including contributing to presentations and minutes.
• Manage and mentor Clinical Scientists, including identifying responsibilities for which Clinical Scientists assume a lead or contributory role, and identify growth opportunities for Clinical Scientists within each project team.
• Implement best practices for Clinical Scientist contributions to all aspects of strategic development, protocol design and conduct, development of key supporting materials, study site and vendor interactions, and data analysis/presentation.
• Participate in leadership meetings within the Chief Medical Officer and Clinical Development organization to identify strategic and operational challenges and potential solutions and collaboration opportunities.

Qualifications:

• Advanced Degree in Life Sciences (e.g., DNP, APRN, PA, or related medical field, PharmD, PhD) with 3 years of experience; will consider a Master's degree with a minimum of 5 years of related experience, or a Bachelor's degree with 8 years of related experience, or equivalent experience.
• Experience working on Oncology trials.