Associate Director – Clinical Operations
NJ, US
Worker Category: Active - Regular full-time
Now is an exciting time to join the company, a leading late stage Oncology company. Our focus is the patient: “To Save A Life Is To Save A Universe”.
We are a company united by strong values – passion towards patients, innovation, integrity, excellence, leadership, ownership and teamwork. Our values reflect the way we strive to improve the quality of life for patients and are at the heart of our company’s success and future growth.
We continue to seek passionate, dedicated, and solutions-oriented people – and consistently ensure that our people develop their talent. If the company is to realize its vision, we need people who think innovatively and act with integrity.
We currently have an opening for Associate Director Clinical Operations in our NJ office.
The Associate Director, Clinical Operations at the company will lead the execution of global and/or local oncology phase 1-3 clinical studies, programs or franchises in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of and interactions with CROs and other external vendors and internal stakeholders to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team.
The Associate Director will take responsibility for the clinical operational strategy and overall delivery of the clinical study (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This role will ensure timely study start-up, execution and study management as well as support of database locks consistent with study/program timelines across the studies under their responsibility.
This role will need strong functional management skills to support ongoing development of staff as well as the ability to define appropriate resource model to support new and ongoing studies. The Associate Director will be expected to take both strategic and tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies, including those involving co-development (Alliance) partners.
Role and Responsibilities:
- Operational Strategy
- Align with the Head of Clinical Development Operations 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.
- Clinical Operations
- 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.
- CRO and Quality Oversight
- Responsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the DS/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.
Requirements:
Experience: 5- 7 years experience in a combination of the following:
- Minimal of 2 years of global trial or project management experience
- Experience in the pharmaceutical/biotech or medical device industry
- Experience in oncology desirable
- Experience with application of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
- Experience with all aspects of clinical trials including on-site monitoring experience.
- Experience in management of CROs and other vendors
Education:
- A minimum of a Bachelor’ s degree in a scientific discipline or equivalent RN/BSN nursing degree (other majors considered with relevant work experience); advanced degree preferred
Skills:
- ICH-GCP and FDA regulatory requirement understanding and competency.
- Strong clinical study management skills, including risk assessment and contingency planning.
- Ability to approach assigned duties in a highly organized, detailed and accurate manner.
- Ability to manage multiple priorities and work in a flexible, dynamic, and fast-paced environment.
- Willingness to travel as dictated by assigned project requirements (approximately 25%). International travel may be required.
- Ability to work cross-functionally with other departments involved in the conduct of a clinical trial including excellent oral/written communication, organizational, problem solving and conflict resolution skills.
- Ability (experience preferred) to work with cross-cultural teams including personnel from global locations as required per project with a positive attitude.
- Microsoft Project, Office, PowerPoint and Excel proficiency.