Vice President, Clinical Operations
PURPOSE: The Vice President of Clinical Operations is accountable for the overall operational strategic planning, oversight and execution of Silverback’s clinical development programs. The Vice President will also lead key strategic Clinical Operations organizational initiatives.
● Lead overall planning and effective management of clinical development programs, trials, and teams including coordinating development of and contributing to study protocols and other study documentation, study implementation and execution, and data delivery and interpretation
● Direct Principal Investigator/site selection; cultivation of collaborative relationships and prioritization of Silverback studies.
● Guide CRO selection and oversight, including all project-specific clinical, data management, pharmacovigilance, and statistical functions.
● Lead patient recruitment initiatives and ensure coordination across clinical trials and development programs.
● Develop, implement and monitor Clinical Operations processes and infrastructure to support adherence to best clinical practice and regulatory guidance, including departmental SOPs and ICH-GCP requirements.
● Support the development and management of departmental budget and monitor expenditures within budget guidelines
● Recruit, develop and retain high performing clinical talent as and when needed.
● Form a cohesive and collaborative Clinical Operations team that effectively and productively interfaces both internally between departments and externally with collaborators and partners.
BS, MS, PharmD, or equivalent in a scientific discipline is preferred. 15 years of progressively more challenging work experience in clinical and drug development, including 5+ years of Clinical Operations management experience. Strong background in pharmaceutical and biotech clinical research.
● Proven ability to provide scientific and clinical expertise to a clinical development program.
● Familiar with advanced concepts of clinical research (including complex study designs) and able to work effectively in a team/matrix environment
● Excellent management of project timelines and driven to achieve corporate goals.
● Must have the ability to build and maintain positive relationships across a broad range of individuals both internally and externally
● Solutions mindset to overcome problems that jeopardize the schedule or the quality of the work.
● Mission-driven individual with high energy and strong levels of perseverance; works toward both individual and team goals.
● Proven ability to effectively collaborate with internal team and external parties in a rapidly growing environment.
● Constructively-direct. Will foster an environment of transparency and direct dialogue about tough issues.
● Thrive in a fast-paced environment and is comfortable with ambiguity. Flexibility and the ability to operate effectively within a dynamic environment will be key.
Develops strategic plans to ensure successful implementation of action plans and objectives where analysis of situations or data requires an in-depth knowledge of the company, competitive environment, technology and economic or social implications of organization activities. Participates in development of corporate methods, techniques and evaluation criteria for projects, programs, and people. Approves budgets and schedules to meet corporate requirements.