Senior Director, Clinical Research

Nuvation Bio•Remote - Any State US, NY

About The Position

Who we are… Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. What you’ll be doing The Senior Director, Clinical Research serves as a key scientific and functional program lead as part of the CRS team. The CRS will be empowered to work collaboratively and cross functionally to support and implement strategic objectives including clinical development plan. You will be responsible for…

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
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

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