Senior Director Clinical Operations
This position is responsible for translating the company’s clinical strategies into effective clinical operations plans. While this role will be a key member of the Clinical management team responsible for developing capability and maintaining quality standards across the clinical organization it will also be a hands-on role involved in day-to-day activities in addition to strategy.
Provide management and leadership oversight of clinical operations staff responsible for trial management of assigned program(s). Clinical operations will include, but is not limited to, developing project timelines and budget as well as resource planning and allocation. Manage clinical trial study deliverables through clinical study teams and other external resources, such as contract research organizations, laboratories, etc. Achieve clinical study deliverables through effective leadership and management of staff, budget, and timelines.
Perform job duties with minimal guidance; identify program risks; proactively create and implement mitigation strategies. Utilize operational expertise and experience to effectively ensure goals are met:
- Establish objectives;
- Develop and implement strategic and operational plans and timelines;
- Maintain business information and timelines: ensure budgets, schedules, and performance requirements for clinical programs are met;
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Direct the selection and negotiation of contracts with CROs and study sites. Direct the creation and implementation of clinical standard operating procedures (SOPs) that meet ICH and FDA requirements. Provide oversight to ensure SOPs are followed across all programs, including with CROs, outside labs, and other third-party vendors;
- Direct the activities of both internal and external resources. Identify additional resource requirements based on business needs to meet goals and milestones. This position will be the point of escalation for internal and external team members;
- Management responsibility includes staffing, training, and evaluating clinical operations staff. Provide leadership oversight for the establishment and maintenance of clinical trial master files and other clinical documents to ensure inspection readiness at all times;
- Position may travel up to 25%;
- Other duties as assigned.
- A bachelor/master’s degree or equivalent with 10+ years’ progressive leadership and management experience in clinical operations, preferably in pharmaceutical or biotechnology industry.
- At least 2 years’ experience at a Director level.
- Proven track record in successful implementation and completion of clinical trial programs.
- Strong leadership skills, expertise in building positive relationships internally and externally; building high performance teams; able to remove barriers to successfully lead individuals/teams to achieve the common business and/or operational objectives.
- Must have excellent communication skills and be able to interact with all levels of the organization.
- Strong financial acumen with experience in budgeting models and spreadsheets.
- Experience in running clinical trials both within the US and abroad.
- The individual must be self-motivated and strive to make a significant impact.
- Must be creative and flexible when solving problems, and able to encourage and engage input from others.
Dynavax is an Equal Opportunity Employer.