The Director Clinical Operations will be a key leader in helping to design, implement and manage the ongoing success of AGTC’s full-service CRO outsourcing strategy. This individual will provide leadership to move the organization to a true vendor oversight model based on mutual trust, reliable and consistent quality, timeliness of delivery, and value-driven results. The individual will collaborate across functions and organizations to ensure both clearly defined accountability within AGTC and successful transfer of appropriate accountability to Vendors. This individual will be a key resource across the organization at all levels – for securing and maintaining alignment in direction and delivery of AGTC’s outsourced activities. Additionally, this individual will design, implement and manage the program timeline and budget in collaboration with AGTC colleagues involved in trial conduct activities.
- The Director of Clinical Operations will report directly to the VP of Clinical Operations.
Essential Duties and Responsibilities
- In collaboration with Development peers, design, document and implement outsourcing operating principles to achieve and maintain quality, timeliness and robust cost management
- Ensure consistent understanding and application of these operating principles and practices across both AGTC and our CRO partners(s) through communication, training, leadership and mentoring
- Manage across all levels of the organization to help obtain buy-in and promote the success of the outsourcing strategy
- Create and implement an onboarding methodology to orient new team members to the outsourcing strategy
- Engage stakeholders in ongoing open dialogue that uncovers challenges and leads to a strengthening of the outsourcing model
- Ensure that robust trending of operational issues and opportunities, risk mitigation planning and proactive management of unforeseen challenges is fully implemented
- Act as a positive role model for the partnership mentality across the organization
- Act as the primary counterpart within AGTC for the CRO Relationship Manager to achieve partnership strategic commitments
- Liaise frequently with AGTC colleagues and CRO counterparts to maintain a full understanding of potential issues and concerns and ensure they are appropriately acknowledged, addressed and resolved in a timely fashion
- Ensure that an atmosphere of trust, openness and mutual respect is established
- Develop a mechanism for celebrating AGTC and CRO(s) mutual successes as well as helping teams manage through challenges
- Ensure appropriate measures of success based on quality, timeliness and cost management are established, reported and acted on
- Establish appropriate forums, both internal and collaborative with the CRO(s) for the exchange of ideas, best practices, process improvements and risk mitigation, as well as a mechanism for the approval, implementation and evaluating the success of those outputs
- Create a robust formal governance structure with the CRO(s) that includes, for each relationship as appropriate, an Executive Steering Committee, a Joint Operations Committee, a Business Operations Committee and a Committee to govern process improvement initiatives
- Ensure formal governance meetings are scheduled, conducted and appropriately documented, and that outputs are communicated broadly throughout relevant areas of both AGTC and CRO(s)
- Design and implement an effective issue escalation pathway. Provide regular training, communication about actions taken and report on results on a timely basis. Provide stakeholders with relevant tools and processes to ensure most issues can be successfully addressed at the program team level.
- Develop a methodology for documenting and reinvesting the contributions of continuous improvement
- In collaboration with Development peers, develop, implement and manage program timeline and budget.
- Establish appropriate forums to review budget, as well as a mechanism for handling budget variances and approvals.
- Responsible for multiple aspects of clinical trial budgets. This includes creating processes around the oversight and management of budgets, providing guidance on decision making related to clinical trial budgets, assisting with budget reconciliation and invoice management activities, and ensuring that Clinical Operations project managers are maintaining budgets within corporate guidelines.
- Responsible for high-level and detailed study budget forecasting for all program/portfolios, including setting baseline budget for RFP processes
- Responsible for budget analyses and recommendations in support of strategic program decision-making
- Houses, tracks and interprets clinical study assumptions, serving as a central source of information
- Manage budgetary requirements of clinical program, by providing consolidated latest estimates on current year budget and future year planning budget. Identify issues and propose mitigating plans for facilitating decision making.
- Track program/trial timelines, resource requirements and expenditures and initiate discussions on variances and adjustments as needed.
- Ensure clinical trial planning and budgeting systems are accurate regarding timelines, forecasts, expenditures and internal resource planning.
- Develop, track and report on program timeline, budget and quality metrics.
- Bachelor’s degree in relevant field and eight (8) years of relevant experience or master’s degree and six (6) years of relevant field experience. At least five (5) years of relevant experience are in a lead or management role.
- Demonstrates extensive clinical trials / program management experience, preferably 10+ years.
- Demonstrates excellence in complex project management and effective management of multiple projects/priorities and budgets.
- Demonstrates understanding of pharmaceutical regulatory requirements and strategic implications for clinical development operations.
- Demonstrates ability to lead multifunctional teams, and mentor and coach more junior staff.
- Extensive experience of managing / overseeing CROs /vendors / external partnerships and relations.
- Excellent verbal, written and presentation skills
AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity. AGTC is an EOE and maintains a drug free workplace. Please send CV or resume to: email@example.com