Vice President, Clinical Operations

Position Summary

The Vice President of Clinical Operations is responsible for the oversight and strategic direction of assigned clinical programs.  The VP ensures milestones are achieved and aligned with corporate goals.

This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Vice President reports to the Executive Vice President, Research and Development. 

Primary Responsibilities

• Provides strategic and tactical leadership, oversight, and support to the Clinical Operations team for the implementation of clinical program development
• Accountable for Clinical Operations deliverables associated with the overarching program, including timelines, budget, applicable vendor oversight, and data quality
• Manages, supports, trains, and mentors the Clinical Operations team members to the highest quality of output on each of their individual studies within the development program
• Ensures Clinical Operations team is completing deliverables within timelines and expected budget 
• Works strategically across all studies regardless of complexity (in terms of design, location, phase, etc.)
• Uses operational and therapeutic expertise to optimize trial design and execution
• Ensures all clinical trials are executed in compliance with international Good Clinical Practice (GCP) guidelines and regulations, as well as Company SOPs 
• Proficiently conducts formal presentations to a wide variety of audiences, including colleagues, investigative staff, CROs, and vendors
• Leads Clinical Operations team in proactive identification and resolution of clinical project issues
• Leads and/or participates in process improvement initiatives as required 
• Leads and/or contributes to the development of clinical operations SOPs, clinical development plans, and other Company initiatives as required

Competencies 

• Well versed on GCP and ICH guidelines as well as FDA and other regulatory requirements 
• Strong knowledge of study management and monitoring procedures 
• Possesses in-depth knowledge in clinical drug development and clinical trial execution
• Thorough understanding of clinical trials methodology, including a working knowledge of protocols and indications being studied
• A team player with the ability to successfully lead and effectively participate in cross-functional teams, including CROs/vendors        
• 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
• Ability to resolve project related problems and prioritize workload to meet deadlines with minimal guidance and support
• High self-motivation 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, processes more efficient, and people more effective
• A high degree of professionalism as evidenced by punctuality and ability to deliver on commitments
• Understanding of the service culture and positive interactions with internal and external team members and CROs/vendors 
• Knowledge of concepts and practices for clinical trial conduct
• 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 15 years of biotechnology/pharmaceutical experience with at least 10 years directly overseeing molecule clinical operations and project management
• Previous experience with Phase I - III studies
• 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.  The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed.  Please note the employment opportunity is not limited to these locations. 

General Salary Range: $325,000 to $360,000