Vice President, Clinical Development

Location
Pleasanton, California
Salary
Comensurate of experience and education
Posted
Jun 19, 2018
Hotbed
NextGen Bio
Required Education
Doctorate/PHD/MD
Position Type
Full time

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.

    Qualifications:

  • 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, build and lead a team.

    Benefits:

    CBT Pharmaceuticals offers medical, dental, vision, competitive PTO days, and 401K plan that includes a company match.