Job Description
What you'll be doing The Vice President, Clinical Operations leads the Clinical Operations function within the Clinical Research and Development organization and reports to the SVP, Data Science and Clinical Operations. Partnering with the clinical research and development functions, the VP, Clinical Operations creates and executes clinical trial action plans and make recommendations to the senior leadership team and EC regarding Clinical Operations strategy. The VP, Clinical Operations develops an empowered team that can navigate in a matrix environment and adjusts quickly to business needs. This role also drives operational excellence through process improvement and knowledge sharing across Nuvation Bio.
You will be responsible for...- Leads the global clinical operations team to execute on Nuvation Bio's clinical trial programs
- Attracts, develops, coaches, and retains high-performance team members, creating a culture of collaboration with an emphasis on performance, continuous learning and career development
- Works with team members to develop systems to ensure consistent, high-quality project management
- Ensures strategic planning, execution, and operational delivery of clinical trials across all programs working in collaboration with cross-functional partners
- Leads planning and management of the clinical programs from an end-to-end trial management perspective to achieve Clinical R&D team objectives
- Shapes the Clinical Operations strategy and translates the strategy into an operational risk management plan by identifying and appropriately escalating trial and program risks to the Clinical R&D leadership team and the Executive Committee
- Acts as Clinical Operations representative at Executive Committee meetings as appropriate
- In collaboration with Medical Writing, writes and/or oversees authorship of clinical operation sections of regulatory documents, including protocols, Investigator Brochures, annual reports, CDPs, and other documents as needed
- Works with the cross-functional Clinical R&D teams in support of regulatory submissions and interactions
- Identifies clinical program/resource gaps, performs project risk analyses, recommends solutions and implements action plans to mitigate risk
- Develops and maintains relationships with clinical investigators, consultants, external service providers and leaders/members of other Nuvation Bio departments
- Works with Clinical Operations team on CRO/vendor qualification and selection processes for outsourced activities, including scope of services agreements, budgets with unit cost negotiation, clinical and translational operational plans, and detailed timelines, and ensure that high-performance expectations are met
- Focuses on Quality to establish and maintain a state of inspection-readiness
- Oversees life cycle budget, including forecast, multi-year cost targets, and annual cost targets for all trials
- Ensures optimal resourcing across trials to meet business needs according to portfolio prioritization. Includes coordination of headcount requests and resource alignment with other line functions
- Leads the development of department processes and best practices, including review of Standard Operating Procedures (SOPs) and development of standard reports, templates, and forms
- Develops and implements operational program-specific standards as required to enhance consistency across trials
What Knowledge & Experience you'll bring to us...- 15+ years of pharmaceutical clinical drug development experience, with 7-8 years minimum in global clinical trial management with direct team leadership and management
- Minimum Degree: Bachelor's degree or equivalent or any relevant and qualifying training education/background in biological sciences or in healthcare
- Ability to coach and lead senior leaders within their own organization and support their career development and success
- Track record of building strong relationships with executive leadership with the ability to influence and impact key decisions at the strategic level
- Demonstrated senior leadership and accomplishment in all aspects of conducting global clinical trials and programs in Oncology
- Significant and close collaboration with Phase 1 investigators in Oncology
- Extensive knowledge of clinical development process, regulatory requirements, translational operations, and Good Clinical Practice (GCP)
- Prior global experience and ability to establish international Clinical Operations strategic plans to reach eligible patient populations and sustain rapid enrollment for programs
- Proven track record in trial management process improvements
- Strong senior leadership, interpersonal and problem-solving skills
- Excellent communication, organization, and tracking skills with involvement in cross-functional, multicultural/international teams
Behavioral skills to be successful...- 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.
What we have for you! - 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.
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