**IMMEDIATE NEED FOR PERMANENT DIRECTOR OF CLINICAL OPERATIONS OPPORTUNITY WITH AN ESTABLISHED ONCOLOGY PHARMA**

Responsibilities:

• Align with the Head of Clinical Development Operations on plans for successful implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area.
• Ensure operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs.
• Ensure high quality delivery of all studies for which they are responsible. This includes individual studies as well as programs or franchises.
• When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.
• Validate the study implementation plan provided by the CRO through to study close out and CSR writing. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).Lead site selection and site qualification discussions, kick-off meetings and study team meetings.
• Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.
• Responsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under their responsibility.
• Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study oversight and execution.
• Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.
• When sitting on a study team, responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.
• Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately.
• People and Resource Management
  • Responsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of employees and contractors to ensure adequate staffing at all times.

Additional Skills & Qualifications:

• Phase III recent oncology experience in Director/AD level required
• 10 or More Years relevant experience required
• Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
• CRA experience preferred
• Direct report leadership exp,
• Global study conduct,
• Presenting and sitting on Global Project Team Meetings
• Bachelors Degree minimum

***MUST SIT OUT OF THE FOLLOWING STATES: NJ, NY, CT, PA, DE, MD***

***Will be required to travel on-site to NJ for important meetings quarterly***

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.