About Skye Bioscience, Inc.:
Skye Bioscience, Inc. is focused on unlocking the pharmaceutical potential of the endocannabinoid system to treat diseases with metabolic, inflammatory, and fibrotic processes. Backed by leading life science venture investors, Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with significant clinical and commercial differentiation. Nimacimab, a negative allosteric modulating antibody that inhibits peripheral CB1, showed a favorable safety and tolerability profile in a Phase 1 trial. Skye plans to start a Phase 2 clinical trial in obesity comparing monotherapy and combination arms of nimacimab and a GLP-1R agonist in mid-2024. SBI-100 Ophthalmic Emulsion, a CB1 agonist, is currently being studied in a Phase 2 clinical trial of patients with glaucoma and ocular hypertension, with interim data expected in Q1 2024.
Skye Bioscience is also a welcoming community of passionate biotech enthusiasts who aren't afraid to voice their opinions. The mission of the team is to enhance lives globally through innovative medicines. They don't claim to have all the answers, but they relentlessly pursue solutions. They invite like-minded, entrepreneurial individuals who resonate with their mission to consider joining them and contribute to their efforts.
About the Role:
The Senior Clinical Project Manager is accountable for the daily operational oversight of one or more clinical trials from start-up, conduct, and close-out activities in accordance with the protocol, trial plans, company SOP, GCP and other applicable regulatory requirements. The individual must be able to work independently and thrives in a fast-paced environment.
Responsibilities:
Operationally oversees trial teams, functional groups, and vendors to communicate company expectations and ensure milestone and deliverables are received on time and within budget. Responsible for assuring compliance with internal SOPs, FDA regulations and GCP.
Leads RFP development, assesses vendors for selection and manages vendor set-up, deliverables, timelines, and budget.
Develop clinical trial documents including ICF templates, trial procedure manuals and trial training materials.
Develop and implement trial processes: site budget negotiation parameters, key performance indicators, IP supply management.
Monitors progress of clinical activities, providing internal communication on the status on trial health, including metrics, deliverables, and budgeting.
Able to anticipate potential trial issues/risks and determine the best method of mitigation.
Oversees data entry timelines, query management and metric reporting. Performs periodic reviews of EDC data for trends and potential risks.
Provides oversight for the setup, maintenance, and close out of the Trial Master File and ensures it is complete and inspection ready
Performs detailed monitoring oversight, ensuring compliance to the monitoring plan and suitability of monitoring strategies and assigned CRAs. Tracks monitoring visit intervals, report completion and report review. May train or re-educate CRAs as needed.
Serves as a site liaison and subject matter expert. Acts as a resource and point of escalation as needed in support of the site/CRO/vendor.
Responsible for ensuring ophthalmology specific deliverables (data, patient profiles, etc.), site materials, training, study plans and manuals are consistent with the indication and representative of Ophthalmic clinical trials.
Proactively identifies (ophthalmology specific) issues, providing training re-education and other mitigations.
Provides input relating to procedure the development, review and implementation of departmental SOPs and processes.
Provide input as the subject matter expert for during regulatory inspections.
Mentor other clinical operation team members and may have direct reports.
May simultaneously lead/manage more than one clinical trial.
Perform other duties as assigned.
Qualifications:
Demonstrates a positive, ‘can do’ and service-oriented attitude. Skilled in developing collaborative internal and external relationships.
Able to lead, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
Excellent interpersonal, written, and verbal communication skills, as position will interface with investigators, site staff and various team members across vendors and functional groups.
Self-motivated, dedicated to quality; detail-oriented with ability to shift priorities quickly under tight deadline.
Experience in managing CROs and other vendors.
Prior monitoring and/or co-monitoring industry experience and willing to perform co-monitoring.
Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint) and web-based data platforms.
Experience
Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
Experience in different aspects of regulatory inspections is preferred.
Ophthalmology clinical trial management experience required; prior ophthalmology specific monitoring preferred.
At least 2 years’ experience in the ophthalmology field (non-research related experience is acceptable).
Strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, data cleaning and monitoring
Proven project management skills and trial leadership ability in phases II and III.
5 to 8 years of direct and progressive industry clinical trial management experience in a biopharma or CRO setting. With a track record of leading multiple projects from protocol development through start-up, recruitment, maintenance, close-out, and CSR finalization.
BS or BA in a relevant scientific discipline, or equivalent combination of education and experience.
