Director, Clinical Research

Nuvation Bio • Remote - Any State US, NY

16h

About The Position

The Director, Clinical Research serves as a key scientific and functional study lead as part of the CRS team. The CRS will be empowered to work collaboratively and cross functionally to support clinical study execution and high-quality clinical data.

Requirements

• Advanced Degree in life sciences (medicine, pharmacy, biology, etc)
• 5+ 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 health authorities
• Extensive data listing review experience for pivotal studies
• 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 and the 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

Nice To Haves

• Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence , curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

Responsibilities

• 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
• 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 date
• 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

Benefits

• Competitive Base Salary, Bonus, and Equity Plans
• Unlimited Vacation and 10 Sick Days Annually
• Excellent Medical, Dental, and Vision Coverage
• 401K with Company Matching
• Full range of medical, financial, and/or other benefits, depending on the level and position offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Director