The Clinical Program Management Director, Clinical Trial Management is an energetic individual with significant clinical drug development knowledge in Phase I-IV clinical trials. This individual will ensure corporate drug development timelines are met and will help to manage a high performing global team in the fast-paced and expanding Global Clinical Operations department within Global Medicines and Development Affairs (GMDA). The position is responsible for the planning, oversight, and execution of program-level deliverables including, but not limited to, developing and managing clinical development plans, developing and managing program and study timelines and budgets, working with cross-functional teams, and communicating status and escalating issues to peers and senior management. This position reports to the Head of Clinical Trial Management in the Global Clinical Operations (GCO) department. The position has a strong affiliation with the Leadership Team of GCO and other senior stakeholders within GMDA.
- Represent GCO as a key program member, responsible for the development and execution of clinical development plans in conjunction with the Medical Lead.
- Provide both strategic (e.g., key decision points and risk, study scenario planning) and operational perspectives (e.g., study timelines and financials) to assigned programs.
- Accountable for operational delivery of all studies within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through to completion of the clinical study report.
- Solid understanding of all elements of clinical trial execution and regulatory reporting, ensuring studies are conducted within the parameters of GCP compliance for all phases of drug development, and assist with remediation as necessary.
- Proactively identify and interpret risks, and implement mitigation strategies/corrective actions to address them.
- Develop precise, accurate, timely and succinct written and verbal communications to provide peers and senior management with status updates, and proactively escalate risks as appropriate.
- Effectively influence and ensure seamless, two-way communications and information sharing with internal and external stakeholders (e.g., KOLs and research sites) to ensure well-coordinated team dynamics and study execution.
- Play a key role in oversight of CROs and other vendors, ensuring clinical trials are executed on time, within budget and with quality.
- Directly manage Clinical Trial Management staff (Clinical Trial Managers) with responsibility for staff recruitment, resourcing, training, performance management, setting individual employee goals and career growth opportunities for staff. May also manage contract staff.
- Contribute to development of strategic plans for Clinical Trial Management and help to translate strategic decisions into actionable operational plans.
- Contribute to development of departmental goals and objectives to achieve corporate goals.
- Monitor key performance indicators and departmental metrics for Clinical Trial Management and identify opportunities to optimize processes and procedures (SOPs, Work Instructions).
- Participate in departmental and cross-functional process improvement initiatives, often as initiative or workstream leader.
- Bachelor of Science degree in a life sciences discipline, advanced degree preferred.
- At least 10 years of relevant work experience in drug development in the biopharmaceutical industry, with experience executing clinical trials globally and providing operational strategy across all phases of development.
- Experience in rare disease is preferred.
- Proven track record of successfully overseeing staff to deliver clinical trials on time, on budget and with quality while ensuring inspection readiness.
- Demonstration of project/program management skills including risk assessment, timeline and budget management and contingency planning.
- Demonstration of effective team leadership in cross-functional matrix teams. Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
- Excellent understanding of GCP, CFR and ICH guidelines
- Significant experience with direct line management of employees.
- Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team and to effectively manage external vendors/CROs.
- Excellent verbal and written communication and presentation skills.
- Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environment with minimal supervision.
- Ability to work in a highly time-sensitive environment and deliver unusually high throughput with acceptable quality when necessary.
- Expertise in Microsoft Project Microsoft Word, PowerPoint, and Excel.
- Experience in financial databases such as TrialTrove, ClearTrial, and IMS.