Director, Clinical Operations

Location
South San Francisco, CA
Posted
May 11, 2022
Ref
4442687004
Required Education
Bachelors Degree
Position Type
Full time

DIRECTOR, CLINICAL OPERATIONS

Position Summary:

The Director, Clinical Operations is a leadership position within GBT’s Clinical Development team.  The Director is accountable for delivery of a clinical program(s).  In collaboration with the Senior Director, Clinical Operations, the Director will influence and implement the development operations outsourcing strategy and execution for GBT’s clinical development program(s).

Essential Duties and Responsibilities:

  • Collaborate with Legal and Finance to lead the resolution of complex contractual and budgetary issues
  • Negotiate contract terms, scopes of work, pricing and payment schedules. Ensure agreements are commercial advantageous to GBT while minimizing risk through close collaboration with functional partners such as legal, finance, and clinical
  • Assist clinical teams in defining scopes of work (SOW) and preparing Study Specification Worksheets (SSWs) for both original contracts and amendments
  • Assist clinical teams in budget development
  • Lead identification and selection of clinical operations vendors
  • Serve as issue escalation point for vendor, including, clinical CRO, issues
  • Collaborate with Business Operations & Analytics team for continued process improvement and ongoing ICH/GCP maintenance
  • Manage direct reports and recruit future internal FTEs and consultants/contractors
  • Contribute to the planning and implementation of clinical development program including scenario planning, forecasting enrollment and timelines, assessment program level feasibility, estimation of resources and budget, and development of operational strategies
  • Contribute to developing department processes to ensure adherence to GBT’s standards, and all applicable regulations and guidelines
  • Contribute to the development and maintenance of the necessary resource and budget forecasting for Clinical Operations
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs
  • Secure all necessary approvals to ensure compliance to SOX and company procedures
  • Report out on a set cadence tracking metrics and suggested process improvements
  • Manage traffic of contractual documents to ensure timely and compliant execution
  • Ensure Vendors/Partners are delivering in line with expectations and contracts
  • Participate in initiatives to drive clinical development objectives
  • Adhere to GBT's Working Practices, and Standard Operating Procedures (SOPs)
  • Establish and maintain clinical forecasting processes including long-term strategic planning, annual planning, monthly rolling forecasts and in-month monitoring
  • Partner closely with other development functions to develop thoughtful forecasts and gain insights into revenue drivers/shifts
  • Help establish and direct KPIs to measure vendor performance
  • Create monthly business updates for management based on KPIs, providing insight into any trends or shifts in the business
  • Identify and quantify financial/operational risks and opportunities to the business
  • Work to continuously improve, automate and scale forecasting processes and methodologies
  • Drive process improvement projects as necessary
  • Work closely with clinical and finance to develop a monthly accrual process to provide timely and accurate clinical cost accruals

Qualifications:

  • Bachelor’s degree required. Master’s degree or higher in health-related science or equivalent preferred
  • Between 9-14+ years of experience or advanced degree (MS/PhD, PharmD) with at least 7 years of experience
  • Experience leading Phase 1-4 clinical trials, both domestically and internationally
  • Experience managing direct reports
  • Excellent organizational skills and attention to detail
  • Effective communication and interpersonal skills
  • Ability to efficiently perform multiple tasks and manage changing priorities
  • A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
  • Demonstrated track record in conducting global clinical trials in an out-sourced model
  • Strong behavioral bias towards productivity and being proactive
  • Excellent interpersonal, communication (oral and written), analytical and organizational skills.
  • Strong influencing and negotiation skills
  • Demonstrated ability to manage multiple projects and complex timelines in a team environment
  • Established leadership capacity in a cross-functional project environment
  • Strong team management and leadership skills, train and mentor team members

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.