Executive Director, Clinical Operations

Location
South San Francisco, CA, United States
Posted
Apr 15, 2021
Ref
5045141002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

This position is a strategic leadership role accountable for leading programs, including all operational activities and cross-functional trial activities, and managing study management staff across the Sana Portfolio. This role is responsible for strategic planning & oversight, delivery of all operational activities in accordance with the Clinical Development Plans (CDPs) and in accordance with GCP guidelines, line management including recruiting, building, and maintaining a best-in-class Study Management organization. This role may take on oversight of Biosample Operations.

DUTIES AND RESPONSIBILITIES
  • Manage all operational and strategic operational aspects of a assigned programs
  • Recruitment and oversight of Study Management staff across Sana Portfolio
  • Give input to Development activities for assigned studies
  • Contribute to resource strategy across studies/programs
  • Collaborate in the development of the target product profiles (TPPs) and CDPs by generating scenario plans, high-level forecasting of timelines, assessing global program-level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies
  • Handle unique challenges and decisions that have an impact on function and disease area.
  • Develops & communicates budget, resource, risks and timelines to review bodies
  • Operate at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise. Long-range planning horizon is typically 2-5 years
  • Accountable for providing program leadership with oversight, guidance, and expertise to all Clinical Operations staff assigned to the clinical program
  • Coaches and mentors Study Team Leaders and Clinical Trial Managers assigned to program on trial leadership activities and appropriately delegates development opportunities
  • May serve as a team lead on non-program/ functional initiative work streams
  • Builds and maintains good relationships with internal and external key stakeholders. Contributes at Core Team level beyond operations and able to give input into Development strategy
  • Member of Development Operations Leadership Team
  • Able to contribute to hiring and sourcing strategy, optimize resources and manage Director level Direct Reports
  • Serves as a primary consultant to senior-level colleagues (eg, Project Team Leaders, Leaders & Medical Directors), functional leadership and cross-functional stakeholders
  • Work is executed independently with oversight from VP Development Ops to ensure strong alignment with broad disease and organizational strategies
  • Leads and develops an environment supportive of innovation and smart risk-taking to drive and implement novel approaches to drug development
  • Leads and supports staff through organizational change and growth and provides input to senior management on potential organizational changes and improvements
  • Champions change with direct reports, dotted line reports and peers to sustain long-term business objectives

QUALIFICATIONS

Basic Qualifications
  • Bachelors (preferably in a Life Science or Business discipline) or equivalent
  • 10 years industry experience
  • Demonstrates excellent communication (written and verbal), presentation and interpersonal skills
  • Displays ability to lead and innovate successfully within a change management culture and fast-paced environment
  • Successfully manages conflict and fosters open communication with others
  • Must be well organized and able to provide senior operational support across multiple ongoing trials or a program
  • Strong knowledge of regulatory requirements relative to GCP's, adverse event reporting, and knowledge of FDA regulations
  • Proven track record showing excellent clinical project management skills including clinical supply logistics and managing to approved budgets
  • Broad understanding of clinical operations in relation to clinical development functions
  • Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
  • Ability to effectively interface with medical personnel at clinical site(s) and also lead multi-disciplinary teams both internally & externally, proven experience in strategic planning
  • Proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs and timelines for programs
  • Strong financial acumen with experience managing clinical program budgets
  • 2+ years of experience in clinical program management or a directly related role
  • Demonstrated exceptional leadership skills (including motivation and delegation), interpersonal skills, influencing, communication and strategic project management skills at all levels of an organization
  • Significant drug development leadership experience, including history of effective management of cross-functional teams thru phase 1-3 drug development and regulatory submissions (NDA/BLA/MAA). Lifecycle experience preferred
  • Proven ability to lead and influence data-driven strategic planning and implementation, including the ability to focus a team to work towards its goals effectively, efficiently and on target
  • Experienced management of drug development budgets and fiscal responsibility
  • Strong skills in: communication, both oral and written; presentation and meeting leadership; coaching and personnel development
  • Ability to effectively manage vendors across a variety of therapeutic areas
  • Ability to help with building infrastructure for the Clin Ops department, including SOPs, processes, inspection readiness
  • Ability to travel as required

Preferred Qualifications
  • Start-up experience
  • Experience managing Direct Reports
  • Experience with Biosample Operations
  • Master's degree

DIRECT REPORTS
  • This position will hire direct reports