Reporting to the Executive Director of Clinical Operations, the Director, Clinical Operations will lead the implementation of the clinical development plan for one of our clinical-stage programs, currently in phase 3 development. The primary responsibilities will be:
- Provide strategic and tactical leadership, oversight and support to the Oncology Clinical Operations Team for the implementation of the program clinical development plan and be accountable for all Clinical Operations deliverables associated with the program including timelines, budget, vendor oversight and data quality
- To lead and manage the Study Execution Team for at least one study if not more
- To support the Exec Director of Clinical Operations in managing relevant CROs/vendors and clinical program budgets
- To manage, support, train and mentor Clinical Trial Managers and other Clinical Operations staff members to the highest quality of output
This is a leadership position that requires experience and proven competency in drug development, clinical trial execution, CRO/vendor oversight and staff supervisory experience. Candidates for this position are expected to be highly accountable and have strong interpersonal, communication and organization skills, allowing them to set and achieve objectives in the execution of the clinical programs of Geron.
- Possesses in-depth knowledge in clinical drug development and clinical trial execution
- Team player and able to work with and lead cross functional teams including CROs/vendors
- Possesses financial acumen and able to identify changes in budget scope and address those changes appropriately
- Ability to think strategically but also able to implement tactically to achieve all program and study deliverables
- Demonstrates excellent knowledge of ICH-GCP, relevant Geron SOPs, and regulatory guidance
- Ability to resolve project related problems and prioritize workload to meet deadlines with minimal guidance and support
- Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment.
- Drive for results and motivates other members of the project team to meet timelines and project goals.
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
- Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with internal and external team members and CROs/vendors, including good interpersonal skills and serves as role models for junior team members
- Communicates both verbally and in written form in an efficient manner.
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and CROs/vendors with a high level of proficiency.
- Possesses practical knowledge of IT tools and systems in use on project team.
EXPERIENCE and COMPETENCIES
The successful candidate will be able to demonstrate the following:
- Bachelor's degree in a scientific discipline or equivalent
- Minimum of 5 years directly related experience overseeing molecule program management and minimum of 12 years biotech / pharmaceutical experience
- Ability to successfully lead a cross-functional study team
- Participated effectively in a cross-functional drug development team
- Knowledge of concepts and practices for clinical trial conduct
- Must be well versed in FDA regulations and GCP
- Previous experience with at least phase 2 and phase 3 studies
- Previous experience managing CROs/vendors
- Previous experience with the development of policies and SOPs
- Thorough knowledge of GCP/ICH guidelines including an understanding of regulatory requirements
- Thorough knowledge of study management & monitoring procedures