Senior Director, Clinical Operations
The Senior Director of Clinical Operations provides operational and implementation expertise to the product/project teams to enable timely progression of clinical development programs. In conjunction with cross-functional team leaders, the Senior Director is responsible for overseeing the execution of quality global programs, working collaboratively within CDMA (Clinical, Clinical Operations, Clinical Quality and Strategic Operations, Data Management, Biostatistics, and Medical Affairs) with Non-clinical, Manufacturing, and Regulatory to execute clinical development programs.
- Provide strategic leadership in developing operational plans and metrics for clinical development programs.
- Create and implement operational outsourcing strategies.
- Oversee identification, qualification, selection and oversight of CROs and vendors. Provides leadership to the Joint Oversight, Quality and Executive Oversight Committees
- Collaborate with Clinical Quality and Strategic Operations function to develop and maintain sound Quality Systems/Plans and ensure inspection readiness across clinical development programs.
- Create a culture of quality and mentor high-performing teams
- Ensure that goals and objectives for all drug development programs are met by providing strategic and tactical input into development; develops study specific goals, tracks metrics, produces executive summary reports.
- Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines for clinical development programs.
- Lead Clinical Operations to effectively accomplish agreed upon deliverables within the timeline established, including but not limited to, review and assessment of Quality Risk Management and implementation of corrective actions.
- Drive the development of clinical SOPs, guidance and quality management plans consistent with GCPs, clinical operations performance standards, and other applicable government and regulatory agency standards.
- Oversee INDs and IND annual trial updates.
Minimum Basic Qualifications:
- BA/BS in a scientific field of study with 18 years of relevant experience
- 15 or more years R & D Clinical Operations experience in biotech, Pharmaceutical or CRO
- Highly advanced knowledge of drug development with experience in clinical operations/program management
- 5 plus years of managing phase I through phase 4 global programs with multiple complex vendor relationships
- 6 plus years of previous staff/line management with proven leadership skills, demonstrated ability to mentor and develop junior employees and heading large development teams in growth environments
- In-depth understanding of industry standards and applicable guidelines
- GCP and applicable FDA/EMA regulations knowledge
- Experience in developing SOPS and Clinical Operations' metrics
- Ability to prepare and present clinical trial and departmental updates to senior management
Preferred Qualifications and Experience:
- Advanced degree (MS/PhD) with sciences major
- Experience with complex acute care trials
- Highly advanced knowledge of Clinical development process.
- Solid knowledge of EMA regulations
- Familiarity with the requirements for drug manufacturing and drug supply prior to initiating clinical studies
- High visibility and prior business impact in a complex global organization
- Effective in building relationships and networks with others across and beyond Cubist
- Works constructively across organizational boundaries despite differences in interests, perspectives, and needs
- Capable of creating alignment within Cubist, both vertically and horizontally, by making a case for one's approach
- Tailors influence strategy and approach using knowledge of target audiences
- Able to adapt influence to specific audiences, to ensure an integrated approach in pursuit of organizational growth and transformative changes
- Able to generate commitment by helping to develop and articulate Clinical Operations future vision
- Provides ongoing clarity as needs change, keeping stakeholders and contributors aligned with changes both in the external environment and across Cubist
- Able to compile, analyze, and present data in a concise manner, in both written and oral context
- Demonstrates ability to enlist input from stakeholders and constituents to make key decisions (e.g. tactics to accomplish goals), while ensuring final decisions are reached quickly and effectively, including situations with ambiguous data and/or uncertainty
- Responsible for developing mid and long-term capability plans to support evolving clinical trial management and oversight function
- Provides both positive and tough performance feedback to both direct reports and staff who may report to others
- Identifies development opportunities for staff, both within and outside of Clinical Operations
- Comfortable stretching people in order to help them grow
- Incorporates succession planning as part of staff development planning
- Occasional overnight travel
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.