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Director, Clinical Scientist

Remote

We’re looking for a motivated and patient-centric Clinical Scientist who wants to have a tangible impact. Reporting to the VP of Clinical Science, you will be a key member of the Clinical Development team with responsibilities to provide scientific support for clinical development activities. This role will collaborate closely with R&D, program management, clinical operations, biostatistics, and external vendors including CROs and consultants. Additionally, the Clinical Scientist will support the development of critical scientific external relationships with key opinion leaders and provide clinical input into safety, data management and regulatory interactions. A working knowledge of drug development process, GCP, ICH guidelines and FDA regulations is highly desired. We’re seeking an individual who is collaborative, thrives in a dynamic culture, and is steadfast in their commitment to advance cutting-edge cellular therapies to impact patients’ lives.  Work location can be hybrid or remote.

This is a unique opportunity to be a key contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

 You will...  

• Contribute to the clinical strategy as part of an integrated drug development team, and provide scientific input to protocol development.
• Contribute to authoring of key documents, including clinical protocols, Investigator’s Brochures, IND summary documents, CTAs for initiation of US and ex-US studies, and responses to questions from regulatory authorities, IRBs, and ethics committees. 
• Prepare data and contribute to scientific publications including posters, abstracts and manuscripts.
• Support data management to ensure completeness and accuracy of the clinical data; create and maintain a tracker as a tool for monitoring clinical data.
• Support pharmacovigilance activities including review of safety reports, safety follow ups, annual summary documents such as DSUR and IB.
• Contribute to the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts involved in the study/project.
• Contribute to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring to develop and implement related sections of the study risk management plan.
• Participate in the update of study documents, eCRF adequacy with protocols/protocol amendments, and help in rationalizing and documenting the data collection needs quantitatively and qualitatively, decreasing the complexity.
• Collaborate with the clinical team on the review, analysis, and interpretation of study results including exploratory endpoints, and ensure appropriate data review and accurate data reporting.
• Develop study specific training material and participate in the Investigators, Study Team, and Monitoring Team training on medical information.
• Support the medical monitor or perform medical monitoring activities.
• Developand cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.
• Provide support to advisory boards, consultant meetings, and investigator meetings including preparation and delivery of presentations.
• Understand competitive landscape and provide insights on strategic developments pathways. 
• Interact effectively with sites, CROs, investigators, study sites, advisors, and regulatory agencies.
• Provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives.
• Rapidly integrate new insights derived from ongoing clinical trials, translational science, or basic science.
• Create compelling data presentations for internal and external meetings.

You bring:

• Advanced degree in life sciences (Pharm D, MS, PhD or equivalent, MD).
• 5+ years of experience in design, planning, executing, reporting, and publishing clinical 
• Strong scientific background, preferably with clinical and/or research experience in medical, surgical, or radiation oncology.
• Strong experience in clinical study design, including scientifically, medically and statistically appropriate endpoints.
• Understanding and ability to apply principles of PK, correlative studies and other studies integrated into clinical research. 
• Comprehensive understanding of the drug development process in all phases of testing with emphasis on Phase 1 and 2 clinical studies.
• Experience with pharma/biotech clinical operations and research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements.
• Successful experience interacting with clinical investigators and medical experts.
• Strong analytical and strategic thinking.
• Familiarity with digital tools for data analytics.
• Excellent verbal, written, and interpersonal communication skills; you synthesize complex information and communicate clearly and succinctly in formal presentations and informal settings. (fluency in written and spoken English is required).
• Personal drive, initiative, good judgment, and an ability to adapt as the organization grows and evolves.
• A track record of managing multiple responsibilities in parallel to deliver critical goals, while adapting to changing priorities.
• A desire and ability to work in an entrepreneurial, collaborative environment. You build healthy, productive and high trust relationships within your function and with direct stakeholders, and effectively influence actions and decisions.
• A willingness and ability to travel as needed. 

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