Sr. Director to Vice President, Clinical Development
Remote - United States
Anywhere in the U.S. (Remote Position) - about 10-20% of travel once pandemic restrictions are resolved.
The position will report to the Chief Medical Officer. Seeking a physician to lead a targeted clinical T-cell therapy program. Depending on the candidate's level of experience, the position will include direct reports. Depending on candidate's background, title ranges from Sr. Director to VP of Clinical Development with increasing responsibilities and independence.
- Drive the execution of the clinical program on a tumor agnostic biomarker-driven basket trial in solid tumors.
- Lead engagement of Key Opinion Leaders
- Lead clinical review of data (including adverse events, efficacy, medical and correlative science data), and for data query generation and resolution.
- Responsible for data analysis and interpretation.
- Lead author of clinical content of documents for interactions with regulatory authorities (i.e.: FDA, Health Canada) and relevant sections of IND, Investigator Brochures, Protocols, and periodic safety reports.
- Work closely with all cross-disciplinary functions (including preclinical and clinical teams, manufacture, bio-analytics, correlative science, regulatory, quality and business development) to ensure integration of all disciplinary components for effective decision making.
- Work closely with CROs and key strategic alliance partners.
- Provide therapeutic area medical and scientific expertise to senior management and key stakeholders.
- Lead execution of external and internal stakeholder meetings (i.e.: IM, KOL, patient advocacy groups, etc.)
- Work with cross-functional team members to prepare manuscripts and external presentation.
- Anticipate trends in medicine and industry that may have an impact on the clinical/commercial viability of products and factor into planning.
- Ensure compliance with corporate policies and procedures, and all related healthcare laws and regulations.
- Medical Doctorate degree is required.
- Board-certified or board-eligible in oncology and/or hematology
- Clinical bone marrow transplant experience or strong immunology background preferred.
- Work experience with genetically engineered T-cell therapies, either in academia or industry
- 3+ years of industry experience in drug development in Phase I-III studies.
- Demonstrated skills in scientific analysis and reasoning. Excellent ability to communicate, specifically on clinical and scientific topics. Ability to distill complex issues into actionable solutions.
- Demonstrated ability to build effective working relationships, influence, negotiate, and drive cross-functional alignment and organizational engagement. Ability to be flexible, incorporate insights from multiple stakeholders and adapt quickly to changing needs of the organization.
- Demonstrated ability in leading high-performing teams and delivering results in a matrix and collaborative environment and operating across multiple geographies.
If you meet the above qualifications & interested in learning more, please contact Bria Gaber at email@example.com.