The Vice President of Clinical Development will oversee all global Clinical programs at CBT. As the Clinical Development Head, he/she will play a key leadership role as CBT develops promising combination immuno-oncology programs with internal and partnered assets. This role will closely interact with the COO and EVP of Clinical to actively participate in the clinical development – design and execution of the clinical development strategy for all single agent and combination programs and provide clinical science and medical leadership within all cross-functional groups within the company. This is a high impact, highly influential role that reports directly to CBT’s President and CEO.
Specific responsibilities include, but not limited to:
- Develop innovative clinical development plans that drive early decision making based on objective clinical safety and efficacy response measures.
- Work collaboratively to develop expedited Proof of Concept programs that lead to seamless late stage development.
- Provide clinical/medical leadership, advice, and guidance for CBT clinical programs to ensure overall safety of study subjects and scientific integrity of CBT clinical trials.
- Collaborate with internal functional leads and external experts to drive innovation in early and late clinical development plans integrating translational measures/precision medicine.
- Represent CBT with partner program meetings and regulatory interactions.
- Function as the Team Leader for some of the combination programs and work in partnership with other team Leader(s) to ensure delivery of high-quality, cost-effective programs that are delivered on time and within budget, while maintaining the necessary resources needed to deliver the program.
- Work closely with senior management and cross functional team members to advance CBT’s pipeline.
- Ensure highest level of rigor and scientific integrity in clinical programs, including, but limited to Investigator brochures, protocols, and study documents.
- Identify and escalate issues in a timely manner as appropriate.
- Identify issues of highest priority in the clinical programs to discuss and resolve with Senior Management.
- MD or MD/PhD with board certification in medical oncology.
- 8+ years of clinical development experience in the biotech or pharmaceutical industry designing and executing oncology clinical trials from Phase 1 through Phase 3, investigator-initiated studies, with experience in immuno-oncology trials preferred.
- Prior experience in managing clinical trials for biomarker-driven cancer therapies is a plus.
- Experience in leading teams in a fast-paced, cross-functional environment.
- Experience in protocol development and design, including understanding of the strengths and weaknesses of study design, development of case report forms and statistical analysis plans.
- Experience in working with CROs.
- Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.
- Motivated to work in a fast-paced, high accountability, small company environment. A “can do” and collegial professional who leads through influence and interpersonal skills.
- Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
- Demonstrated ability to collaborate successfully with multiple functions in a team environment.
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral form. Must be able to analyze and interpret clinical efficacy and safety data and develop written reports and presentations.
- Ability for strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader.
- Ability and desire to grow with the company, assume greater responsibility and build and lead a team.
CBT Pharmaceuticals offers medical, dental, and vision insurance to keep you and your family healthy. CBT also offers competitive PTO days, so you can take time off when you need to. Plus, CBT offers a 401K plan that includes a company match.
CBT Pharmaceuticals, Inc. is an innovative biopharmaceutical company committed to becoming a global leader in the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to tame cancer. The company’s existing pipeline of five development-stage assets include three novel humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and two targeted therapies against uncontrolled growth signaling pathways.
The company was founded in 2016 with locations in Pleasanton, California and Hangzhou, P.R. China. The company will relocate to Foster City, California by 1Q2019.