Role Description

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.

You will be responsible for:

• 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.

Qualifications

• 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.

Requirements

• 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.

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.
• And much more!