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Geron Corporation · 1 day ago

Vice President, Clinical Science and Operations

United States

Full-time

Remote

Director/Executive

$325K/yr - $365K/yr

15+ years exp

Geron Corporation is seeking a Vice President of Clinical Science and Operations to lead the strategic direction of clinical development programs. This senior leadership role involves overseeing clinical trials, ensuring alignment with corporate goals, and mentoring teams to optimize clinical operations and data generation.

BiopharmaBiotechnologyHealth DiagnosticsOncologyPharmaceutical

Diversity & Inclusion

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

Qualification

Clinical drug developmentTrial executionRegulatory complianceLeadership skillsPost-marketing studiesBudget managementClinical methodologyCross-functional collaborationAnalytical skillsCommunication skillsInterpersonal skillsOrganizational skillsProblem-solving skills

Required

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

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

Benefits

Medical

Dental

Vision

Life insurance

Flexible spending accounts

Disability insurance

Supplemental health insurance

401(k) retirement savings plan

Employee stock purchase plan

160 hours of vacation during each full year of employment

64 hours of sick leave

9 standard paid holiday days off

Paid leave for certain life events

Company

Geron Corporation

Geron is a biopharmaceutical company that is charting a new course with the goal to deliver innovative treatment options for people living with blood cancer.

Founded in 1990

Foster City, California, USA

201-500 employees