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.
The position of Associate Director, Clinical Trial Operations works closely with the Vice President, Clinical Operations to ensure that Nuvation Bio delivers high quality clinical trial data efficiently, cost-effectively, and in alignment with corporate objectives. This role will independently manage external vendors on the execution of Nuvation clinical trial protocols in a highly dynamic, growing environment. Additional accountabilities may include day-to-day personnel management and development; resourcing and budget projections for individual studies or programs; partnership with external vendors and clinical sites; collaborative development of standard procedures to ensure compliance with clinical trial-related regulations and guidelines.
You will be responsible for…
-
This role will serve as the clinical operations study lead for clinical trials including project planning, budget and resource management, and oversight of the Contract Research Organization(s) and project vendors. With support, this role may also serve as the program lead for a given compound.
-
Manage/oversee the conduct and execution of an assigned clinical trial and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
-
Responsible for the identification, review and selection of appropriate investigational sites and vendors
-
Management and oversight of CROs, and selected study vendors; ensuring all vendors meet the predetermined program milestones according to budget and timeline.
-
Works closely with study team to prepare and maintain manuals, forms, plans, and documents, and participates 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.
-
Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.
-
Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.
-
Ensure clinical studies are executed within projected budget, on time, and with highest quality.
-
Support the development and management of clinical site budgets and vendor contracts, including review of invoices for accuracy.
-
Works with Data Sciences to create and implement study-specific tools to ensure clean data and timely data entry.
-
Acts as a cross functional liaison to ensure study plan aligns with program level goals.
-
Write and/or review clinical operations SOPs and related quality documents including, but not limited to, training, tools, templates, CRO manuals, and vendor oversight plans.
-
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 including start-up, enrollment, maintenance, and close-out.
-
Prior experience (either in leadership or as a regional lead) in global Phase 3 studies is required.
-
Prior experience in managing, retaining, and developing clinical operations personnel is preferred.
-
Current knowledge and understanding of FDA and ICH Guidelines, including Good Clinical Practices (GCP) E6(R2) requirements.
-
Able to interact and influence effectively with multi-functional teams at all levels of the organization within Development.
-
Must be self-motivating and 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 of development (early to late stage).
-
Travel will be required for clinical investigative site visits, vendor visits, meetings, and presentations.
Communication & Interpersonal Skills:
-
Excellent communication and interpersonal skills.
-
Must be able to write clearly and summarize information effectively.
-
Must be able to present complex information to various audiences.
Significant Contacts:
-
Internal employees and functional heads.
-
External service providers.
Requirements:
-
Minimum Educational Requirement: Bachelor’s Degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) and/or Business Administration
-
Experience: 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. Early and late-stage experience (Phase 1-3) preferred.
-
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.
- 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!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
