Each individual will be leading their own study.
Last time we were looking for only phase 3 experience but this time we are open to phases 1 and 2 experience as well.
The exact study they will lead will depend on their skill set. Still looking for experience in global studies, oncology, sponsor/CRO management, and leadership/management experience.

This role provides Clinical Operations expertise in cross-functional meetings and initiatives. Mentors junior Clinical Operations staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Accountable for overall management of multiple clinical trials including:
• providing strategic direction to study teams to meet corporate study goals and timelines;
• oversight of vendor budgets and contracts, in conjunction with Development Outsourcing reporting and justification of study metrics to executive management, as requested
• Contributes expertise in all operational activities pertaining to the execution of clinical trials
• Partners with and maintains regular contact with relevant Exelixis departments such as Regulatory Affairs (RA), Biostatistics and Clinical Data Management (BCDM), and others as necessary
• Participates in the selection of Contract Research Organizations (CROs) for both large budget (>$20 million) and small budget (<$1 million) trials
• May attend CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
• Provides consistent, regular oversight of CRO and vendor performance
• In partnership with Clinical Operations senior management contributes to definition, development and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices
• Contributing member of various study and program teams such as the Study Management team (SMT); provides direction to lead CTMs in creating meeting agendas and documenting outcomes and deliverables
• Contributes to the development of staffing/resourcing plans
• May act as designee for Vice President, Clinical Operations, as appropriate
• Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed

Job Types: Full-time, Contract

Salary: $85.00 - $97.00 per hour

Ability to commute/relocate:

• King of Prussia, PA 19406: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

• Do you have?

• BS/BA and a minimum of 11 years of related experience; or 
• MS/MA degree in related disciplineand a minimum of 9 years of related experience; or 
• Equivalent combination of education and experience

• Do you have Experience in Biotech/Pharmaceutical industry(Not Mandatory)?
• Do you have Management experience including outsourcing to Contract Research Organizations (CROs).
• JOB COMPLEXITY: 

• Has an in-depth knowledge of the functional area, business strategies and the company’s goals. 
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results. 
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results. 
• Creates formal networks involving coordination among groups. 
• Serves as an external spokesperson for the organization

Work Location: One location