Director, Clinical Scientist

What You'll Do:

Serve as a core clinical development team member supporting multiple oncology, hematology, and/or cell therapy programs 
Perform ongoing review and interpretation of clinical data, including safety, efficacy, and longitudinal patient data  
Act as a primary contributor and owner of key clinical deliverables, including: Clinical study protocols and protocol amendments, Investigator’s Brochures, Clinical study reports and data summaries, and Regulatory submission documents (e.g., INDs, amendments, briefing materials) 
Collaborate cross-functionally with Clinical Operations, Regulatory, Biometrics, Translational Sciences, and Medical teams to ensure high-quality and timely study execution 
Support clinical trial conduct and oversight, including data review, issue identification, and resolution  
Contribute to regulatory interactions and submissions, including preparation of FDA-facing materials and global regulatory documentation  
Partner with Clinical Operations to support patient enrollment strategy and execution, including upcoming U.S. and Australia expansion  
Synthesize increasing volumes of clinical and follow-up data to generate actionable insights for program decision-making  
Support engagement with external investigators, CROs, and key opinion leaders  
Contribute to the evolution of clinical development processes and infrastructure as the organization scales 

What You'll Bring:

Advanced degree required: PharmD, PhD, or MS in a health or life sciences field  
3–6+ years of experience in clinical development within biotech or pharma, preferably in a Clinical Scientist or similar role  
Experience in oncology, hematology, and/or cell and gene therapy strongly preferred
Demonstrated experience authoring and contributing to: Clinical protocols and amendments, Investigator’s Brochures, and Regulatory submission documents and clinical datasets  
Strong understanding of clinical trial design, execution, and data interpretation  
Ability to independently analyze complex clinical data and communicate insights clearly  
Comfortable operating in a hands-on, execution-focused role with high ownership of deliverables  
Strong cross-functional collaboration skills in a fast-paced, matrixed environment  
Experience supporting IND submissions and/or global regulatory activities preferred  
Ability and interest to grow into a leadership role as the clinical team expands 
 
The anticipated salary range for candidates for this is below. The final salary offered will depend on several factors, which may include, but is not limited to, relevant years of experience, skills, qualifications, job knowledge, and educational background.