Vice President, Clinical Science and Operations

Position Summary

The Vice President of Clinical Science and Operations is a senior leadership role responsible for the oversight, execution, and strategic direction of clinical development programs across all phases, including post-marketing activities. The Vice President ensures milestones are achieved and ensures that Clinical Science and Clinical Operations strategies align with corporate goals, regulatory requirements, and industry best practices to advance the Company’s product pipeline, support commercialization efforts, and optimize post-marketing data and evidence generation. The Vice President is accountable for delivering high-quality clinical programs across all phases (I–IV), including post-marketing studies, ensuring alignment with regulatory, commercial, and organizational goals. The Vice President plays a critical role in guiding cross-functional teams, optimizing trial design and execution, and mentoring talent within the clinical organization. The Vice President is a critical member of the early- and late-stage Product Development Team (PDT) and Research and Development Leadership Team (RDLT) and works to drive proactive identification and resolution of clinical project issues.

This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Vice President will report to the Executive Vice President, R&D and Chief Medical Officer.

Primary Responsibilities 

• Lead and integrate the scientific and operational strategies for clinical development programs, spanning early development and Phases I–IV and post-marketing studies, to support regulatory submissions, commercialization, and lifecycle management
• Collaborate with executive leadership and cross-functional partners to align clinical development plans with corporate objectives and commercial priorities as part of RDLT
• Provide guidance to the Chief Medical Officer, Head of R&D, and senior leaders on clinical trial design, data interpretation, risk management, and scientific rigor
• Direct the development and oversight of clinical protocols, study designs, and scientific plans as a member of the early- and late-stage PDTs
• Oversee planning, initiation, and execution of clinical trials, ensuring delivery on time and with high quality
• Oversee feasibility assessments and select trial geographies to ensure strategic fit and operational efficiency
• Drive site/investigator selection, engagement, and relationship management to optimize enrollment and site performance
• Oversee contract research organization (CRO) and vendor management, ensuring compliance, performance, and issue resolution
• Manage clinical program budgets, track spending, and align resources with portfolio priorities
• Oversee and support post-marketing trials and real-world evidence generation initiatives on safety, efficacy, and market value
• Support collection, analysis, and reporting of clinical and post-marketing data to ensure accurate safety monitoring and continuous product profile optimization
• Engage and collaborate with key opinion leaders, healthcare professionals, vendors, and CROs to enhance study execution, scientific validity, and product adoption
• Lead, mentor, and develop high-performing Clinical Science and Clinical Operations teams, fostering a culture of innovation, accountability, and continuous professional growth
• Ensure Clinical Science and Clinical Operations deliverables meet timelines, budget, quality, and compliance standards
• Ensure clinical trials comply with ICH-GCP, global regulatory guidelines, and internal SOPs
• Drive proactive identification and resolution of clinical and operational issues and lead process improvement initiatives
• Represent the Clinical Science and Clinical Operations departments in internal leadership forums, external presentations, and cross-functional governance bodies
• Collaborate on the preparation of regulatory submissions, including post-marketing commitments, safety updates, and payer evidence packages as part of RDLT
• Lead and contribute to process improvement initiatives, development of department SOPs, and clinical development plans

Competencies 

• In-depth knowledge of clinical drug development, trial execution, study management, and monitoring procedures
• Strong understanding of IND enabling activities and studies
• Strong understanding of trial design, clinical methodology, and study protocols across phases and indications
• Expertise in post-marketing studies, real-world evidence generation, and lifecycle management
• Well-versed in GCP, ICH guidelines, and global regulatory requirements (FDA, EMA, etc.)
• Strong analytical skills with the ability to translate complex data into actionable insights
• Strategic mindset with proven ability to balance long-term planning and day-to-day execution
• Financial acumen with ability to assess and manage budget scope changes
• Proven leadership and team-building skills with a focus on results and accountability
• Ability to lead and collaborate across cross-functional teams, including CROs and external vendors
• Ability to motivate teams to meet deadlines and project goals with minimal oversight
• Excellent verbal and written communication skills
• Polished presenter with the ability to engage internal and external stakeholders effectively
• Strong interpersonal skills with a professional, service-oriented mindset
• Highly organized, self-motivated, and capable of independent decision-making
• Strong ability to resolve project issues and prioritize competing demands
• Committed to continuous improvement and process optimization

Experience

• Advanced degree (MD, PhD or PharmD preferred) in medicine, pharmacology, biology, or a related field strongly preferred; Bachelor’s degree in a scientific discipline plus extensive clinical experience will also be considered
• Minimum of 15 years of experience in clinical development, including leadership roles
• Proven track record of success in leading clinical programs through regulatory approval, commercialization, and post-marketing phases
• Experience building and leading cross-functional teams
• Previous experience with pre-clinical and Phase I - IV studies
• Previous experience managing CROs/vendors   

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: $325,000 to $365,000