Director, Clinical Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead or assist in the design of studies and amendments alongside both internal and external scientific stakeholders.

• Work in collaboration with MDs, regulatory bodies, and internal partners on protocols, amendments, regulatory submissions, and documentation.

• Create and execute data quality plans, and oversee the medical data review and safety trend analysis.

• Act as the primary contact for clinical inquiries from CRO medical monitors and other stakeholders.

• Prepare clinical presentation slides and communications for meetings, site visits, training sessions, newsletters, and study sites.

• Develop and maintain study startup documents and resources, which include ICF, Lab Manual, EDC, and Safety Monitoring Plan.

• Participate in safety meetings and review potential safety events.

• Formulate communication strategies for studies, encompassing KOL interactions, advisory boards, medical meetings, publications, and events.

• Draft or evaluate abstracts, posters, scientific meeting content, presentations, and materials intended for public distribution.

• Coordinate submissions to scientific meetings and relevant venues.

• Write clinical science sections for meeting packages and assist with clinical documentation for regulatory submissions.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

• A Master’s degree (or equivalent) is required; a PhD, PharmD, or MD is preferred.

• At least 5+ years of relevant experience is necessary with a PhD or similar degree.

• A minimum of 2+ years’ experience in conducting or supporting oncology/hematology clinical studies.

• Exceptional written and verbal communication skills are essential.

• Proficiency in interpreting immunology/immuno-oncology translational data as well as clinical data is required.

🏝️ Benefits

• Potential bonus.

• Stock options.

• Comprehensive benefits package.

• Variable compensation may be included in the overall compensation package.

• We are an Equal Opportunity Employer.