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
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. 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.