Senior Clinical Trial Manager

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 Clinical Trial Manager will be responsible for the operational management and oversight of clinical trials, sites, and vendors within a clinical development program. This role works closely with the Clinical Operations team as well as other key cross-functional team members to ensure that Nuvation Bio conducts high quality clinical trials efficiently, cost effectively, and in alignment with corporate deliverables and timelines. Additional accountabilities may include collaborative development of program level operational strategy, budget projections, and day-to-day personnel management and development as needed.

You will be responsible for…

• Plan and organize the implementation of clinical studies to ensure that the studies are delivered on time, on budget and to quality as expected from planning, initiation, implementation, to completion.
  • Develops and track quality and risk management plans for clinical studies, organizes feasibility studies at the study, country and/or study center level, identifies participating countries and/or study centers, and develops subject recruitment strategies.
  • Responsible for the preparation of clinical operation related documents, including clinical study required documents, ethics committee review materials, genetic resources related filings, and domestic and international clinical trial disclosures.
  • Organize investigator/monitor meetings and ensure that they receive adequate and appropriate training
  • Develop clinical monitoring plans and oversee their implementation and ensure the quality of clinical monitoring through co-monitoring or other means.
• Organize clinical study teams and identify appropriate external vendors.
• Plan and manage clinical study budgets.
• Organize regular internal and external meetings to maintain oversight of internal deliverables and external vendors.
• Regularly review clinical trial required documents to ensure their completeness and filing in the Trial Master File within the required timelines.
• Regularly report on study progress, milestones, and major risks and issues.

What Knowledge & Experience you'll bring to us...

• Minimum Educational Requirement:
  • Bachelor’s Degree preferably in Life Sciences (e.g. Biology, Chemistry, Pharmaceuticals), Business Administration or related discipline or equivalent experience.
• Experience:
  • At least 5 years experience managing or supporting clinical trials and/or directly applicable experience in drug development, ideally includes a small, start-up environment.
  • Oncology experience preferred.
  • Experience managing clinical trials staff directly or indirectly desirable.
• Core Competencies:
  • Direct, prior experience with selecting and managing CROs and other key vendors.
  • Direct, prior experience with multiple phases of clinical trials including start-up, enrollment, maintenance, and close-out.
  • Current knowledge and understanding of FDA, CFDA, and ICH Guidelines, including Good Clinical Practices (GCP) E6(R3) requirements.
  • Proficient with MS Word products and database software; experience in directly using electronic data capture.
  • Familiarity with drug development processes across all phases of development (early to late stage).
  • Travel may 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 self-motivated and able to prioritize/manage a large volume of work in a dynamic, changing, growing start-up culture.
  • Must be able to present complex information to various audiences

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.

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.