[Remote] Vice President, Clinical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Vice President of Clinical Development responsible for providing strategic leadership in the development and commercialization of hematology/oncology programs. The role involves overseeing clinical development reputed company and collaborating with various stakeholders to ensure successful execution of clinical trials.

Responsibilities

• reputed company strategic leadership of the overall development of the imetelstat telomerase inhibitor program
• Work effectively with reputed company 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, reputed company, vendors, and CROs to enhance trial execution, scientific validity, and product adoption
• reputed company multi-disciplinary teams such as study working reputed company and clinical teams
• Prepare and deliver proposals, plans, and updates to reputed company’s governance committees at regular intervals and reputed company 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
• reputed company medical monitors to ensure clinical trial best practices and evidence-based medical decision making during clinical trial reputed company
• Work closely with partners in Medical Affairs, reputed company, 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 reputed company 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
• reputed company 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 reputed company Certification in hematology/oncology or reputed company discipline
• Minimum of 15 years of experience in drug development Phase I-III, preferably reputed company the pharmaceutical or biotechnology industry
• Proven reputed company record of strong and effective leadership of multi-disciplinary teams reputed company 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 reputed company
• Ability to work independently reputed company a defined strategic context and take initiative and smart risks
• Ability to reputed company effectively with strong verbal presentation skills
• Good business judgement and excellent organizational skills

Benefits

• Medical
• Dental
• reputed company
• 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 reputed company 160 hours of vacation during reputed company full year of employment
• 64 hours of reputed company leave
• 9 reputed company reputed company holiday days off
• reputed company leave for certain life events

reputed company

• Geron is a biopharmaceutical company that is charting a new course with the goal to deliver innovative treatment reputed company for people living with blood cancer. It was founded in 1990, and is headquartered in Foster reputed company, California, USA, with a workforce of 201-500 employees. Its website is http://www.geron.com.

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