Director of Clinical Operations

Position Summary:

The Director, Clinical Operations is an expert in clinical trial implementation and drug development for a rapidly growing pediatric rare disorder biopharmaceutical company. This individual must have a solid understanding of clinical research processes and the global regulations that govern both patient privacy and clinical research. S/He must also be an instant contributor who is quick-on-their-feet and have the leadership experience to immediately orchestrate multiple internal and external parties to ensure flawless execution of the current clinical research trials.

S/He must have strong financial acumen and the ability to manage clinical trial budgets to ensure expected financial deliverables are attained. S/He must be a mature leader who is able to mentor and develop direct reports. This individual must be able to perform at a high level of independence and be able to make strategic decisions through appropriate interactions with direct supervisor.

Asklepion is a growing company which requires its personnel to also be independent contributors when required within the team atmosphere. The individual will need to be able to work in a small growing company in a start-up company fashion where one wears multiple hats at any given time. This role may also have other responsibilities assigned as the needs of the organization require.

Major Duties and Responsibilities:

Communication:
  • Open, effective, and proactive communication of the clinical operations activities (program risk mitigation, compliance metrics, alliance management) is critical for success in this role. Must have an excellent understanding of the pharmaceutical development process in order to effectively manage internal and external cross-functional teams.
  • Communicates study status regularly to key stakeholders regarding quality, cost and timelines and escalates unresolved issues to direct supervisor
Leadership:
  • Excellent oversight of vendors in adherence to ICH E6 (R2) data integrity requirements.
  • Identify, qualify, audit, and manage 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.
  • Oversee clinical study execution (set up to close out) to ensure studies are completed on time, within budget, and in compliance with current SOPs, regulations and ICH/GCP guidelines
  • Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocol. Identify any gaps in company/CRO SOPs and develop internal SOPs as needed
  • Identify, qualify, manage, and maintain relations with clinical trial sites such that site-based risks are managed proactively.
  • Directly involved in leading site set up activities including field visits working with partner CRO/s
  • Prepare site recruitment plans based on thorough feasibility assessment and research prioritization
  • Mentor and supervise clinical operations staff and develop plans to grow clinical research capabilities as needed according to the growth of the organization
Execution:
  • Performs project management responsibilities in the management and coordination of the clinical research activities performed by both in-house staff and service-specific vendors
  • Assess clinical research vendor contracts, negotiate pricing and contracts
  • Lead internal and external resources to achieve deliverables, to implement and mitigate resourcing strategies which deliver on efficiency and value
  • Develop and implement performance metrics based on benchmarked KPI (key performance indicators) & KRIs (Key Risk indicators) to track deliverables as per contractual obligations
  • Responsible for ensuring the trial is “audit ready” at all times using an audit plan
  • Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective site, CRO, and sponsor locations throughout trial conduct. Notify and prepare team for regulatory agency audit and address any audit observations appropriately and in a timely manner.
  • Responsible for clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans, and CSRs.
  • Assist with the development of presentations, handouts, and coordination of Investigator Meetings.
  • Create and ensure execution of mentoring and development plans for direct reports
  • Provide expertise, training and guidance on clinical research

Requirements/ Qualifications:

Education:
  • Bachelor’s degree in life sciences is required. Advanced degree is preferred.
  • PMP certification is desirable.
Experience:
  • Minimum of ten (10) years of relevant clinical research and operations experience required
Special Skills/ Abilities:
  • Thorough understanding of FDA, EMA, HIPAA clinical research regulatory requirements, good clinical practices, project management and data handling
  • Ability to delegate work to direct reports to commensurate with their skills
  • Builds a learning environment that recognizes the value of each contributor and promotes a solutions orientation.
  • Ability to constructively challenge, question, and provide creative suggestions for all standard clinical trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services.
  • Willingness to collaborate with team to identify and implement in best practices for optimizing performance.
  • Strong leadership skills in leading study team members and vendors.
  • Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight
  • Strong organizational, communication and interpersonal skills
  • Ability to prioritize, delegate and execute to meet project deadlines.
  • Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms).
  • Demonstratable expertise in financial oversight of clinical budgets, challenges, negotiating tools and budgeting strategies in alignment with executed contracts.
Supervision:

Reports to the Chief Medical Officer


To learn more and to apply, please send your first and last name, a cover letter, and resume to careers@asklepionpharm.com.