Job Description
What you'll be doing The Director, Clinical Research serves as a key scientific and functional study lead as part of the CRS team. The CRS will be empowered to work collaboratively and cross functionally to support clinical study execution and high-quality clinical data.
You will be responsible for...- 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 date
- 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
What Knowledge & Experience you'll bring to us...- Advanced Degree in life sciences (medicine, pharmacy, biology, etc);
- 5+ 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 health authorities
- Extensive data listing review experience for pivotal studies
- 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 and the 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
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.
DisclaimerThis 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 AgenciesAll 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.
