[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.ResponsibilitiesProvide strategic leadership of the overall development of the imetelstat telomerase inhibitor programWork 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 authoritiesEngage and collaborate with key opinion leaders, healthcare professionals, vendors, and CROs to enhance trial execution, scientific validity, and product adoptionLead multi-disciplinary teams such as study working groups and clinical teamsPrepare and deliver proposals, plans, and updates to the Company’s governance committees at regular intervals and when requestedWillingness to roll-up sleeves and be hands-onSupport regulatory submissions and processes as appropriate, including protocol amendments, approval applications, investigator brochure updates, and othersOversee medical monitors to ensure clinical trial best practices and evidence-based medical decision making during clinical trial oversightWork closely with partners in Medical Affairs, Commercial, and Marketing to ensure medical and clinically appropriate and compliant publications, literature, and resourcesCollaborate with Pharmacovigilance and Drug Safety to ensure appropriate safety monitoring practices on pre and post marketing clinical studiesCollaborate on the preparation of regulatory submissions, including post-marketing commitments, safety updates, and payer evidence packages as part of RDLTManage vendors and consultants as appropriateDevelop and manage external relationships with hematology/oncology clinical leaders, including PIs, Steering Committees, Safety Monitoring Committees, and Advisory BoardsSkillsM.D. or equivalent with Board Certification in hematology/oncology or related disciplineMinimum of 15 years of experience in drug development Phase I-III, preferably within the pharmaceutical or biotechnology industryProven track record of strong and effective leadership of multi-disciplinary teams within an environment of oncology drug development, particularly Phase I-IIIThorough understanding of clinical hematology/oncology and the drug development process, including regulatory, drug supply, preclinical development, and commercializationSolid understanding of hematology and cancer cell biology and its application to clinical experimentationStrong strategic skills and agilityAbility to work independently within a defined strategic context and take initiative and smart risksAbility to articulate effectively with strong verbal presentation skillsGood business judgement and excellent organizational skillsBenefitsMedicalDentalVisionLife insuranceFlexible spending accountsDisability insuranceSupplemental health insuranceA 401(k) retirement savings planAn employee stock purchase planA generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment64 hours of sick leave9 standard paid holiday days offPaid leave for certain life eventsCompany OverviewGeron is a biopharmaceutical company that is charting a new course with the goal to deliver innovative treatment options for people living with blood cancer. It was founded in 1990, and is headquartered in Foster City, California, USA, with a workforce of 201-500 employees. Its website is http://www.geron.com.