REQ 294 AD, Clinical Operations

Nuvation Bio•Remote - Any State US, NY

35d•Onsite

About The Position

Nuvation Bio is a biopharmaceutical company focused on addressing critical unmet needs in oncology through the development of innovative therapeutic candidates. Our goal is to transform cancer treatment by creating medicines that significantly improve the quality of life and survival rates for cancer patients. The Associate Director, Clinical Trial Operations plays a key role in ensuring the efficient and high-quality execution of clinical trials, aligning with Nuvation Bio's corporate objectives. This position involves independent management of external vendors for clinical trial protocol execution in a fast-paced, growing environment. Responsibilities also include personnel management and development, budget and resource forecasting, collaboration with external partners and clinical sites, and the development of standard operating procedures to ensure regulatory compliance.

Requirements

Direct, prior experience with selecting and managing global CROs and other key vendors.
Direct, prior experience managing and leading Study Management Teams for all stages of clinical trials (start-up, enrollment, maintenance, close-out).
Prior experience (leadership or regional lead) in global Phase 3 studies.
Current knowledge and understanding of FDA and ICH Guidelines, including Good Clinical Practices (GCP) E6(R2) requirements.
Ability to interact and influence effectively with multi-functional teams at all organizational levels within Development.
Must be self-motivated, able to prioritize, and manage a large volume of work in a dynamic, changing, growing start-up culture.
Proficient with word processing, spreadsheet, and database software, clinical and financial systems.
Familiarity with drug development processes across all phases (early to late stage).
Bachelor’s Degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) and/or Business Administration.
7-10 years of applicable industry experience in drug development, especially in a small, start-up environment.
3-5 years of personnel management experience.
Oncology experience required.
Excellent communication and interpersonal skills.
Ability to write clearly and summarize information effectively.
Ability to present complex information to various audiences.
Problem-solving skills: diagnose inefficiencies, determine root causes, and recommend solutions.
Ability to establish and nurture effective relationships with colleagues and stakeholders.
Credibility through thorough understanding of clinical methodologies and sound analytical support.
Emotional intelligence, curiosity, and a knack for building better solutions.
Effective listening, conveying, and receiving ideas; maintaining a consistent flow of information.
Accountability and a clear sense of ownership.
Adaptability to manage in an environment of ambiguity and embrace change.

Nice To Haves

Prior experience in managing, retaining, and developing clinical operations personnel is preferred.
Early and late-stage experience (Phase 1-3) preferred.

Responsibilities

Serve as the clinical operations study lead for clinical trials, including project planning, budget and resource management, and oversight of Contract Research Organizations (CROs) and project vendors.
Manage and oversee the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
Identify, review, and select appropriate investigational sites and vendors.
Manage and oversee CROs and selected study vendors, ensuring they meet predetermined program milestones within budget and timeline.
Collaborate with the study team to prepare and maintain manuals, forms, plans, and documents, and participate in internal cross-functional study team meetings.
Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, and clinical study reports.
Ensure compliance with GCP and global regulatory guidelines.
Maintain inspection readiness for clinical trials throughout their lifecycle.
Recommend and implement innovative processes to enhance clinical trial management and deliverables, including contingency planning.
Ensure clinical studies are executed within projected budget, on time, and with the highest quality.
Support the development and management of clinical site budgets and vendor contracts, including invoice review.
Work with Data Sciences to create and implement study-specific tools for data accuracy and timely entry.
Act as a cross-functional liaison to ensure study plans align with program-level goals.
Write and/or review clinical operations SOPs and related quality documents, including training materials, tools, templates, CRO manuals, and vendor oversight plans.