[Remote] Vice President, Clinical Development

Note: The job is a remote job and is open to candidates in USA. Geron Corporation is seeking a Vice President of Clinical Development to provide strategic leadership for the development and commercialization of hematology/oncology programs. This role involves overseeing clinical trial strategies, collaborating with stakeholders, and ensuring compliance with regulatory processes.

Responsibilities

• Provide strategic leadership of the overall development of the imetelstat telomerase inhibitor program
• Work effectively with internal and external stakeholders to ensure efficient execution of clinical trial programs including study design, protocol writing, start up, execution, analysis, and submission to regulatory authorities
• Engage and collaborate with key opinion leaders, healthcare professionals, vendors, and CROs to enhance trial execution, scientific validity, and product adoption
• Lead multi-disciplinary teams such as study working groups and clinical teams
• Prepare and deliver proposals, plans, and updates to the Company’s governance committees at regular intervals and when requested
• Willingness to roll-up sleeves and be hands-on
• Support regulatory submissions and processes as appropriate, including protocol amendments, approval applications, investigator brochure updates, and others
• Oversee medical monitors to ensure clinical trial best practices and evidence-based medical decision making during clinical trial oversight
• Work closely with partners in Medical Affairs, Commercial, and Marketing to ensure medical and clinically appropriate and compliant publications, literature, and resources
• Collaborate with Pharmacovigilance and Drug Safety to ensure appropriate safety monitoring practices on pre and post marketing clinical studies
• Collaborate on the preparation of regulatory submissions, including post-marketing commitments, safety updates, and payer evidence packages as part of RDLT
• Manage vendors and consultants as appropriate
• Develop and manage external relationships with hematology/oncology clinical leaders, including PIs, Steering Committees, Safety Monitoring Committees, and Advisory Boards

Skills

• M.D. or equivalent with Board Certification in hematology/oncology or related discipline
• Minimum of 15 years of experience in drug development Phase I-III, preferably within the pharmaceutical or biotechnology industry
• Proven track record of strong and effective leadership of multi-disciplinary teams within an environment of oncology drug development, particularly Phase I-III
• Thorough understanding of clinical hematology/oncology and the drug development process, including regulatory, drug supply, preclinical development, and commercialization
• Solid understanding of hematology and cancer cell biology and its application to clinical experimentation
• Strong strategic skills and agility
• Ability to work independently within a defined strategic context and take initiative and smart risks
• Ability to articulate effectively with strong verbal presentation skills
• Good business judgement and excellent organizational skills

Benefits

• Medical
• Dental
• Vision
• Life insurance
• Flexible spending accounts
• Disability insurance
• Supplemental health insurance
• A 401(k) retirement savings plan
• An employee stock purchase plan
• 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
• Paid leave for certain life events

Company Overview