Vice President, Clinical Development
Geron
- Foster City, California, United States
- Foster City, California, United States
Über
This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Vice President will report to the Executive Vice President, R&D and Chief Medical Officer.
Primary 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
Competencies
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
Experience
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
EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Benefits All regular-status, full-time employees of Geron are eligible to participate in the Company\'s comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with 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, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron\'s intention to comply with all applicable federal, state, and local laws that apply to the Company\'s employees.
Salary Statement Offered compensation is determined based on market data, internal equity, and an applicant\'s relevant skills, experience, and educational background.
General Salary Range: $385,000 to $425,000
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Sprachkenntnisse
- English
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