Senior Director, Clinical Research

Nuvation Bio is a biopharmaceutical company focused on developing innovative therapeutic candidates for oncology. The Senior Director, Clinical Research will lead scientific and functional programs, contributing to clinical development plans and overseeing clinical trials to ensure data integrity and quality.

Responsibilities:

• Develop and support the clinical scientific strategies of the Clinical Development Plan (CDP)
• Contribute to the design, start-up, execution, analysis and communication of the clinical studies for a product candidate
• Review and author clinical documents as needed
• Deep understanding and familiarity with assigned study and protocol requirements
• Responsible for scientific oversight, data integrity and quality of the clinical trials(s) with attention to details to all aspects of assigned clinical studies
• Drive and support all study related activities including:
• Maintenance of clinical documents
• Protocol writing, amendments, informed consent
• Provide study related data to support regulatory documents (IB, regulatory documents, etc)
• Site and CRA training
• Site selection and activation in collaboration with clinical operation
• Collaborate with clinical operation to define study activities, deliverables, instructions relating to assigned studies (e.g. IVRS, central lab, site monitoring plan, lab manual, etc)
• Eligibility review
• Data review, analysis and interpretation of clinical trial data
• Demonstrate advanced understanding of clinical protocols
• In collaboration with Clinical Operations, responsible for timely delivery of high-quality clinical study data analysis
• Form and enhance working relationships with external clinical research partners/vendors to support clinical development of a drug product candidate
• Support regulatory activities, medical affairs, and payer engagements; represent Nuvation Bio in external scientific and medical forums

Requirements:

• Advanced Degree in life sciences (medicine, pharmacy, biology, etc)
• 10+ years of working experience in clinical research/development in Phase 3/pivotal space in Oncology or equivalent with demonstrated proficiency in clinical research and development
• Experience in pivotal study conduct and regulatory interactions with the FDA (additional global regulatory authorities is a plus)
• Extensive data listing review experience for pivotal studies
• Demonstrated ability to lead the development of project strategy and to be accountable for project plans, timelines, progress, and outcomes
• Expert knowledge in ICH/GCP and all aspects of clinical research and development including study design, statistics, and clinical operation
• Experienced in protocol writing, data review and cleaning, ability to analyze, interpret and communicate data with clarity
• Deep knowledge in disease, competitive landscape, pipeline compounds, and regulatory requirements
• Strong knowledge of other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
• Proven leadership and collaboration skills in managing teams both directly and indirectly
• Ability to work and lead in a matrix environment
• Ability to effectively communicate and present data in front of external audience and at multiple levels within the organization
• Ability to travel nationally and internationally as needed
• An equivalent combination of education and experience may be considered