Associate Director, Clinical Operations

Position Summary

The Associate Director of Clinical Operations is responsible for execution of the clinical trials for the Company's clinical-stage programs. This position is remote with a periodic presence for in-person meetings in the Parsippany, NJ headquarter office.

Primary Responsibilities

• Provide support to the oncology Clinical Operations team for the implementation of the program clinical development plan
• Accountable for all clinical operations deliverables associated with the program, including timelines, budget, vendor oversight, and data quality
• Lead and manage the operational team for at least one trial
• Support the Head of Clinical Science and Operations in managing relevant CROs, vendors, and clinical program budgets
• Ensure completion of study deliverables
• Work on trials with moderate to high complexity (in terms of design, location,
• phase, etc.)
• Use operational and therapeutic expertise to optimize trial design and execution
• Ensure all clinical trials are executed in compliance with international GCP guidelines and regulations, as well as Company SOPs
• Conduct formal presentations to a wide variety of audiences, including colleagues, investigative staff, CROs, and vendors
• Proactively identify and resolve clinical project issues
• Participate in process improvement initiatives as required
• Contribute to the development of SOPs, clinical development plans, and other Company initiatives as required

Competencies

• Possesses in-depth knowledge of clinical drug development and clinical trial execution
• Possesses financial acumen and ability 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
• Strong knowledge of study management and monitoring procedures
• Understanding of clinical trials methodology, including a working knowledge of protocols and indications being studied
• Well-versed in concepts and practices for clinical trial conduct
• Demonstrates excellent knowledge of GCP/ICH, SOPs, and regulatory guidance
• Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal guidance and support
• Highly self-motivated with the ability to work and plan independently, as well as in a team environment
• Results-driven and able to motivate other members of the project team to meet timelines and project goals
• Possesses a focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Demonstrates a high degree of professionalism, as evidenced by punctuality and the ability to deliver on commitments
• Understanding of the service culture and ability to maintain positive interactions with internal and external team members and CROs/vendors
• Strong interpersonal skills
• Polished and efficient communicator, both verbally and in written form
• Possesses practical knowledge of IT tools and systems in use on project team

Experience

• Bachelor's degree in a scientific discipline or equivalent
• Minimum of 7 years of biotechnology/pharmaceutical experience
• Previous experience with Phase 2 and Phase 3 studies required
• Previous experience managing CROs/vendors
• Previous experience with the development of policies and SOPs

EEO Statement:

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron's intention to comply with all applicable federal, state, and local laws that apply to the Company's employees.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background.

General Salary Range: $180,000 to $200,000