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[Hiring] Director, Clinical Research @Nuvation Bio

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