Greater NYC Area
CC- VP Clinical Development Oncology
5 months ago
The Vice President Clinical Development is a new position created in the company with direct impact on the drug development life cycle projects.
The candidate for this role will be responsible to lead the Phase I- Phase III Clinical Development Team for design, IND submission, execution and oversight of first in human clinical trials. Complete understanding of dose selection rationale, biomarker plans, and the relevant compliance framework for clinical development activities are essential.
- Lead clinical science aspects of design, execution, interpretation and reporting of clinical trials
- Collaborate with technical experts and scientists to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy
- Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables
- Collaborate with academic scientists, clinical experts, and study investigators
- Represent and advocate for the project in internal and external venues
- Clinical leadership for business development and partnership activities as needed
- MD or MD-PhD or equivalent medical degree with US board certification
- 10+ years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required
- Demonstrate capacity to think creatively when addressing complex situations
- Demonstrate excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs
- Experience in leading pre-IND and IND meetings with health authorities is highly desirable
- Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
- Able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery
- Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project management including peer to peer interactions with academic scientific experts, KOLs and stake holders
- Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.
- Excellent organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into clinical development strategies.
- Travel requirement up to 15-20 % of the time