The clinical operations expert level individual will be responsible leading the execution of one or more clinical trials within one or more multiple indications. Activities include: oversight of external partners managing operational execution of US/Ex-US protocols for Kallyope, provide oversight and management of vendor selection activities from bid (RFP) to award through contract execution; deployment of tactical steps and strategies to enable achievement of company objectives as it relates to the clinical development phase of the program.
- Oversight of the trial timeline from inception (synopsis stage), start up, treatment phase and close out.
- Leadership/coordination for trial related submissions and other regulatory quality deliverables for Kallyope clinical trials according to corporate processes and timelines.
- Providing operational input on study design, protocol development, trial work orders, study related plans, manuals, and guidance documents (and/or oversight of vendor completion of such documents)
- Recommend and/or assess potential CROs and vendors in collaboration with internal functional areas.
- Able to use tactical knowledge to contribute to company process and infrastructure building (SOP development, templates, processes)
- Experience in providing operational input, review, and problem solving for biometrics related activities (including data review, discrepancy resolution, team meetings/presentations) with senior management as needed.
- Experience in leading trial related meetings and leading vendor lead meetings.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- BS degree or equivalent.
- 15+ years of increasing responsibility in clinical operations (trial execution) in a pharmaceutical company (candidate with CRO experience are eligible; however, sponsor level experience is required) with a strong track record in leadership of successfully executed trials (phase 1, 1b, 2, POC).
- Strong ability to build peer relationships and communicate effectively with cross-functional and external teams.
- Deep expertise in outsourcing and CRO management and strong budget oversight for fully outsourced trials.
- Successful experience in a small startup pharmaceutical company where the need to take on a hands-on approach, work assertively with little oversight, and a “wear many hats” is understood and exercised.
- Highly proactive, methodical, and ability to persistently gauge progress with a risk-assessment approach to oversight of trials.
- Confident leader with proven ability to apply knowledge base to effectively manage, mentor and motivate staff to achieve corporate objectives.
- Able to successfully establish relationships, communicate effectively within/across company disciplines, and thrive within a small startup environment
- Equally skilled at leading external teams at remote locations.
- Well-honed study leadership skills; proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines in a fast-paced setting.
- Attention to detail and commitment to high quality and on-time deliverables.