Geron Corporation · 5 hours ago
Vice President, Clinical Development
Geron Corporation is seeking a Vice President of Clinical Development who will provide strategic leadership for the development and commercialization of hematology/oncology programs. The role involves overseeing clinical trial strategies, collaborating with stakeholders, and ensuring compliance with regulatory processes.
BiopharmaBiotechnologyHealth DiagnosticsOncologyPharmaceutical
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
Qualification
Required
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
401(k) retirement savings plan
Employee stock purchase plan
Generous time off program
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.
Funding
Current Stage
Public CompanyTotal Funding
$999.54MKey Investors
Pharmakon Advisors
2024-11-07Post Ipo Debt· $250M
2024-03-19Post Ipo Equity· $150M
2023-01-05Post Ipo Equity· $227.84M
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