The Clinical Operations Senior Director/Director will support the clinical development programs for the investigational drug candidates in company sponsored trials and assist in building clinical capabilities at Kallyope.
Candidate will provide leadership, project management, and program oversight to plan and conduct several high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of eventual regulatory authority submissions.
The Clinical Operations Senior Director/Director will manage all operational aspects of clinical development projects. Open effective, and proactive communication of the clinical development activities is critical for success in this role. Must have an excellent understanding of the drug/device development process in order to effectively manage internal and external stakeholders. Must have strong work ethic and be able to work independently and productively. Must be willing to travel as needed (<< 20% anticipated).
- Responsible and accountable for the conduct of clinical trials including all aspects of trial design, trial set up, conduct, close out, and reporting.
- Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality.
- Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
- Work collaboratively with cross functional internal and external teams including regulatory affairs, medical writing, drug metabolism, and biostatistics, and CRO partners
- Assist in identifying, qualifying, auditing, and managing all external vendors, including CROs. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives.
- Assist in departmental standup and building a growing clinical organization. Identify any gaps in company/CRO SOPs and develop internal SOPs as needed.
- Responsible for ensuring quality and compliance and adherence to GCP.
- Performs oversight of trial with CMO to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
- Provides regular updates to CMO and development team, vendors and contract staff concerning status and progress of the trial.
- Manages each project within agreed upon timelines.
- Proactively monitors and reports trial progress and performance, timelines, and financial metrics on an ongoing basis to management team, including current status of study milestones and forecast budgetary requirements based on scope of work.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- BS/BA degree required in science/health-related field preferred. A Pharm D., Master’s or doctorate degree is a plus.
- Vendor management experience and experience managing outsourced trials required.
- Experience in departmental stand up activities and SOP/Policy implementation strongly desired.
- Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
- Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward.
- Excellent written and oral communication and presentation skills
- The ability to manage multiple priorities, while maintaining attention to detail is critical.
- Experience operating effectively within a matrixed environment, specifically in a biotech start-up setting.
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
- Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels.