We are seeking a Senior Clinical Scientist to assist our Chief Medical Officer (and/or designated Development Lead) in all areas of clinical development strategy, study protocol development, ongoing clinical data review, evaluation, documentation, and reporting. This person will be responsible for all scientific aspects of studies and have a leading role providing clinical science input into regulatory strategy and documents.
- Assist in scientifically sound development of the clinical portions of an integrated development plan
- Conduct preclinical and clinical safety data reviews and provide clinical science input into program deliverables
- Represent clinical science at development team meetings, operations team meetings, and other appropriate forums
- Collaborate with functional area leads from CMC, Clinical Operations, Safety, Project Management, Bioanalytical, Regulatory, Statistics, and Safety to ensure clinical strategies defined by executive management are being employed
- Prepare and conduct clinical science/program relevant slide presentations required by the project or clinical study (Internal data reviews, training CRO, Kick Off meetings, initiative visit etc.)
- Serve as a primary point-of-contact for scientific based questions related to your study/program.
- Liase with both internal and external partners to oversee bioanalytical (pharmacodynamic and pharmacokinetic) set up, assay development, and results reporting for clinical programs
- Manage extraction and assimilation of data outputs for team review, CMO review, dose escalation meetings, interim analysis, and other forums
- Coordinate and lead relevant interfaces with key consultants and internal team members on regulatory interactions and strategies (e.g. PreIND meetings, IND development plan, protocol design)
- Actively perform research and review of the scientific literature for the purpose of drawing insights which in turn enable strategies for company programs
- Drive team accountability for completion of company goals related to regulatory milestones and other program milestones.
- Work with statistical functions to ensure accurate completion of the statistical analysis plan and accuracy of table listing graph outputs (for interim analysis and final TLFs )
- Coordinate, oversee, and lead medical writing activities (e.g. clinical study report process) in accordance with program timeliness
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- A minimum of 6 years of clinical science experience in the pharma/biotech industry including established track record of success within Phase 1 – III drug development projects
- Proficiency in medical writing
- The capability to extract relevant preclinical/clinical data for summation within clinical study reports, IMPDs, investigational brochures, study protocols, and other submission-relevant documents
- Experience working on a multifunctional clinical development team (or equivalent) and in working in a diverse environment
- A strong team player, assertiveness, and the ability to “wear many hats” as required within a small startup environment where delegation is not an option.
- The ability to evaluate, interpret, and synthesize scientific data and verbally present and critically discuss clinical trial data in internal and external meetings
- Strong interpersonal, verbal communication, and influencing skills
Additional preferred experience includes:
- The ability to support and/or coordinate interfaces with external Key Opinion Leads, advisory boards, or other outside entities
- Well-versed and familiar with regulatory requirements pertaining to GCP, GLP and GMP
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.