AbbVie Pharmacyclics Senior Director, Operational Excellence Clinical Operations in Sunnyvale, California
Senior Director, Operational Excellence Clinical Operations
Location: Sunnyvale, CA
# of Openings: 1
Leads the Development Operations Operational Excellence group. Provides direct functional and line management of each of between 3-5 staff. The SD/ED is the primary person responsible for developing and implementing continuous process simplification and optimization initiatives across the entire Development Operations department, both in the US as well as OUS. These processes and process initiatives frequently will overlap with other functional groups at PCYC. The ED/SD therefore will be responsible for ensuring consultation from and alignment with each of those groups as they are or are not impacted. The SD/ED is also responsible for developing and/or implementing and managing clear metrics on clinical trial performance and benchmarking those against relevant peer groups in the Industry. Will consistently be exploring way of optimizing and simplifying the way clinical trials are run at PCYC making sure that PCYC becomes a top tier operational organization compared to relevant industry peer groups. This position requires extensive and detailed knowledge and understanding of all operational aspects of clinical trials,- the ability to multitask, and to adapt to rapid change within a complex environment.
Key Accountabilities/Core Job Responsibilities:
Clinical Trial Process:
· Facilitate the development and maintenance of short term and long term strategic process improvement (simplification and optimization) plans for the department.
· Establish a center of operational excellence for Global Development Operations
· Facilitate the development and maintenance of the necessary resource and budget forecasting for the group.
· Oversee the development and maintenance of processes and activities to ensure that the all systems and activities across the clinical trial portfolio are efficient and at the same time GCP compliant and GCP inspection ready at all times.
· Develop and maintain an overall process map for the clinical trial process.
· Develop and track well defined metrics on all aspects of clinical trial performance benchmarking performance against relevant industry peer groups.
Clinical Development Operations:
· Establish key working relationships with other Development Operations senior leaders to develop and maintain as a core strategic imperative for the department a continued focus on process simplification and optimization through operational excellence.
· Collaborate with other Development Operations senior leaders on the development of the annual strategic plans for the department.
· Collaborate with other relevant functional groups to ensure awareness and integration of continued improvement and operational excellence initiatives into the way we work
Strong communication skills (verbal and written); effective in interaction cross-functionally and with senior leadership across the development organization.
Intense drive and organizational expertise are necessary to manage the diverse group of functional activities
Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
Must have significant experience managing and overseeing clinical trials, CRO management, direct management of clinical operations staff and documented work on operational process work.
Must have GCP inspection preparation and support experience, both clinical site and sponsor GCP inspections
Excellent judgment and problem solving skills
Provide direct reports with appropriate coaching, mentoring and development
Hands-on ability to think strategically and tactically
Entrepreneurial spirit with can do attitude, commitment to teamwork, and initiative
Knowledge and experience with managing complex clinical development situations
Proficiency in monitoring budgets and overseeing expenditures
Demonstrated ability to lead teams or task forces in the development of Development Operations processes, plans and tools
Excellent interpersonal skills
Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas
Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
Minimum of 15 years prior relevant experience and a minimum of at least 10 years in the pharmaceutical/biotech industry and/or relevant clinical research organization
Prior management/supervisory experience leading operational groups
Experience building clinical operations groups including clinical quality management function and associated infrastructure
Experience in process optimization and simplification work
clinical operations experience and leadership skills (e.g., managing cross functional study teams, managing outside collaborators)
# 3 or more
# 3 or more
# 1 or more
# 1 or more
Management of Direct Reports and Group Staff:
· Oversees assigned staff member recruitment and on-boarding
· Oversees the work of direct reports to ensure on-time, on-target and within-budget results
· Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources
· Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports
· Provides formal performance reviews and career development planning for all direct reports
· Complies with all company HR policies and procedures, as well as state/federal employment-related laws
Education Requirements (degree, certifications, etc.):
- MS in scientific discipline, MPH, PharmD, PhD or MD
Demonstrate high level, high quality leadership of diverse Development Operations functional groups
Detailed knowledge of Good Clinical Practices and regulatory requirements
Detailed knowledge of the concepts of clinical research and drug development
Detailed knowledge and understanding of the universe of clinical trial processes and process optimization
On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file/fax/or copy documents, and write or use a keyboard to communicate through written means
Walking and lifting up to 20 pounds may be required
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Equal Opportunity Employer Minorities/Women/Veterans/Disabled