The clinical operations expert level individual will be responsible for 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, and 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.
- Demonstrated experience in set up and deployment of operational systems for the trial . Examples include IWR, ediary, adjudication committee, central scorer/reading, etc.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- BS degree or equivalent.
- 10+ 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). Experience in a start-up environment is a plus.
- 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.
Kallyope is a new biotechnology company headquartered in New York City. Founded by Richard Axel, Tom Maniatis, and Charles Zuker from Columbia University, Kallyope is focused on the identification of new therapeutic and nutritional opportunities involving the gut and gut-brain axis. The Company leverages the founders’ formidable expertise in molecular biology, neuroscience, and behavior to identify new approaches to human health.
Kallyope is seeking creative, highly motivated individuals who are interested in working in a biotech environment that is scientifically stimulating, highly collaborative, and laser focused on translational biology. The Company is creating an industry-leading platform employing cutting edge technologies including sequencing, genetics, circuit mapping, neural imaging and bioinformatics. By integrating and applying complementary tools and approaches to the understanding of gut and gut-brain biology, Kallyope aims to develop transformational therapeutics and consumer products to improve human health and nutrition.
The Company is headquartered in the Alexandria Center® for Life Sciences, a state-of-the-art, collaborative life science campus in the heart of Manhattan, with close proximity to New York City’s world-leading clinical and research institutions. Kallyope has raised $252M in funding from several top-tier investors. The Company has assembled a leadership team and advisory group with a proven track record of success and strong expertise in drug discovery and translation. The founding scientific team is composed of highly creative and talented individuals with outstanding expertise in the Company’s core platform technologies. For more information, see www.kallyope.com.