[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