Associate Director, Clinical Strategy and Delivery (Oncology)

11 Premier Research International LLC; North Carolina; On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking an Associate Director, Clinical Strategy and Delivery (Oncology) to lead clinical delivery and strategic operations across biotech and pharma collaborations. You will guide protocol execution, risk management, and the integration of delivery strategies to ensure timely, compliant trial progress.

You will mentor teams, drive risk-based monitoring initiatives, manage project budgets, and foster strong client relationships, delivering high-quality outcomes in a

Qualifications

• Bachelor's degree in a related field or equivalent combination of education, training or work experience.
• Eight years of clinical research experience with at least five years in Clinical Trial Management, Clinical Lead or Project Management.
• Line management experience preferred.
• Oncology experience prioritized.
• Experience with Risk Based Monitoring methodologies and concepts.
• Expertise with central monitoring approaches and systems and tools.
• Strong leadership and strategic thinking abilities.

Responsibilities

• Oversees protocol execution risks and ensures a closed-loop on issue resolution.
• Leads clinical project teams and mentors team members as required.
• Supports commercial activities such as Bid Defense meetings, representing clinical operations and risk-based monitoring components.
• Evaluates the Risk Assessment and Categorization Tool (RACT) for quality, consistency, and ICH compliance.
• Participates in initial Risk Assessments and ongoing Risk Review meetings for assigned projects.
• Develops customer relationships, manages expectations, and triages escalations.
• Oversees financial performance of the project from the Clinical delivery services perspective.
• Proactively identifies overburn and out-of-scope activities and advises contingency measures.
• May line manage clinical staff as required.

Skills

Clinical leadership

Strategic thinking

Team mentoring

Financial management

Risk Based Monitoring

Line management

Education

Bachelor's degree in related field

Tools

Central monitoring tools

Job description

Prenumer Research is looking for a Associate Director, Clinical Strategy and Delivery (Oncology) to join our Clinical Strategy and Business Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll Be Doing:

• Oversees clinical teams’ management of protocol execution risks related to clinical delivery, ensuring a “closed loop” on issue resolution.
• Oversees clinical project teams and provides support and mentoring to individual team members, where required.
• Supports commercial activities such as Bid Defense meetings, representing clinical operations and Risk Based monitoring components.
• Evaluates the Risk Assessment and Categorization Tool (RACT) for quality, consistency, and ICH compliance.
• Participates in the initial Risk Assessment and in the on-going Risk Review meetings for assigned projects.
• Develops customer relationships, manages customer expectations, and triages customer escalations where required.
• Oversees financial performance of the project from the Clinical delivery services perspective.
• Proactively identifies overburn and out of scope activities and collaborates with Project management to implement appropriate contingency measures.
• May line manage clinical staff as required

What We Are Searching For:

• Bachelor’s degree in a related field, or equivalent combination of education, training and prior work experience.
• Minimum of eight years clinical research experience with at least five years of Clinical Trial Manager, Clinical Lead or Project Management experience.
• Line management experience highly preferred
• Oncology experience highly prioritized
• Experience in implementation of Risk Based Monitoring methodologies and concepts.
• Expertise with central monitoring approaches and systems and tools
• Strong understanding and experience with financial management of projects.
• Must demonstrate strong leadership skills and strategic thinking abilities.
• Less than 30% of travel required

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $140,000 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.