Associate Director - Medical Capabilities, NRDG Operations
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
Nuvation Bio are seeking an experienced leader to build,and direct our Non-Registrational Data Generation (NRDG) operations. This pivotal role involves creating the framework, processes, and governance for all NRDG activities, including Investigator-Sponsored Research (ISR), Collaborative Research Studies (CRS), and other external data generation initiatives. The associate director will ensure the operational and financial oversight of clinical research initiated and conducted by external researchers.
The ideal candidate will be a hands-on leader capable of building new programs from the ground up. You will serve as the central cross-functional partner, ensuring all NRDG activities are aligned with Medical Affairs priorities, executed with the highest level of compliance, and managed through operationally excellent processes.
You will be responsible for…
Establish, build, and manage a comprehensive Non-Registrational Data Generation (NRDG) program, including the creation and implementation of all associated Standard Operating Procedures (SOPs).
Establish, lead, and manage a review committee or equivalent governance body responsible for the review and approval of all ISR, CRS, and other external research proposals.
Serve as the primary author and owner for all SOPs related to NRDG operations, ensuring continuous improvement and regulatory compliance.
Design and implement streamlined end-to-end operational processes for the intake, review, tracking, and completion of all external research.
Lead the identification, selection, and implementation of an enterprise-level operations system to manage all NRDG activities, ensuring it is fit-for-purpose and globally scalable.
Create, implement, and manage a robust NRDG budget forecasting model to increase forecasting accuracy and oversee all NRDG budget planning and tracking.
Manage all external vendors supporting NRDG activities, including budgeting, contracting, and performance management.
Serve as the primary Medical Affairs cross-functional partner for NRDG, liaising extensively with Medical Affairs Strategy, Field Medical, Legal, Compliance, Clinical Drug Supply, Clinical Development, and Finance.
Act as the internal Subject Matter Expert (SME) on Fair Market Value (FMV) as it relates to external research activities.
Responsible for Alliance Management inclusive of meeting coordination and alignment of agendas.
What Knowledge & Experience you'll bring to us...
Bachelor’s degree in life science, pharmacy, or medical-related field with 7 + years of experience in the pharmaceutical or biotech industry, specifically in Medical Affairs operations.
Experience establishing and leading a Review Committee or equivalent governance body for ISR and/or Collaborative Research programs.
Direct, hands-on experience building new Medical Affairs programs from inception, including the creation, review, and implementation of all associated SOPs.
Demonstrated success in identifying, selecting, and implementing an enterprise-level operations system (e.g., for ISR management) for company-wide use.
Expertise in creating and building budget forecasting models for external research, leading to increased budget accuracy.
Experience as a functional operations lead for external research programs.
Deep knowledge of the compliance and regulatory landscape for NRDG, ISR, and other external research activities.
Exceptional project management, communication, and leadership skills.
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.
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Associate Director - Medical Capabilities, NRDG Operations
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
Nuvation Bio are seeking an experienced leader to build,and direct our Non-Registrational Data Generation (NRDG) operations. This pivotal role involves creating the framework, processes, and governance for all NRDG activities, including Investigator-Sponsored Research (ISR), Collaborative Research Studies (CRS), and other external data generation initiatives. The associate director will ensure the operational and financial oversight of clinical research initiated and conducted by external researchers.
The ideal candidate will be a hands-on leader capable of building new programs from the ground up. You will serve as the central cross-functional partner, ensuring all NRDG activities are aligned with Medical Affairs priorities, executed with the highest level of compliance, and managed through operationally excellent processes.
You will be responsible for…
Establish, build, and manage a comprehensive Non-Registrational Data Generation (NRDG) program, including the creation and implementation of all associated Standard Operating Procedures (SOPs).
Establish, lead, and manage a review committee or equivalent governance body responsible for the review and approval of all ISR, CRS, and other external research proposals.
Serve as the primary author and owner for all SOPs related to NRDG operations, ensuring continuous improvement and regulatory compliance.
Design and implement streamlined end-to-end operational processes for the intake, review, tracking, and completion of all external research.
Lead the identification, selection, and implementation of an enterprise-level operations system to manage all NRDG activities, ensuring it is fit-for-purpose and globally scalable.
Create, implement, and manage a robust NRDG budget forecasting model to increase forecasting accuracy and oversee all NRDG budget planning and tracking.
Manage all external vendors supporting NRDG activities, including budgeting, contracting, and performance management.
Serve as the primary Medical Affairs cross-functional partner for NRDG, liaising extensively with Medical Affairs Strategy, Field Medical, Legal, Compliance, Clinical Drug Supply, Clinical Development, and Finance.
Act as the internal Subject Matter Expert (SME) on Fair Market Value (FMV) as it relates to external research activities.
Responsible for Alliance Management inclusive of meeting coordination and alignment of agendas.
What Knowledge & Experience you'll bring to us...
Bachelor’s degree in life science, pharmacy, or medical-related field with 7 + years of experience in the pharmaceutical or biotech industry, specifically in Medical Affairs operations.
Experience establishing and leading a Review Committee or equivalent governance body for ISR and/or Collaborative Research programs.
Direct, hands-on experience building new Medical Affairs programs from inception, including the creation, review, and implementation of all associated SOPs.
Demonstrated success in identifying, selecting, and implementing an enterprise-level operations system (e.g., for ISR management) for company-wide use.
Expertise in creating and building budget forecasting models for external research, leading to increased budget accuracy.
Experience as a functional operations lead for external research programs.
Deep knowledge of the compliance and regulatory landscape for NRDG, ISR, and other external research activities.
Exceptional project management, communication, and leadership skills.
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.