Senior Director / Vice President, Head of Clinical Development Operations

Location
South San Francisco, CA, United States
Posted
Jun 06, 2021
Ref
5253629002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
We Are Genetic Navigators bringing together passionate, creative and dedicated professionals to join a rapidly-growing startup on our mission to translate novel genetic insights into lifesaving medicines. We are integrating human genetics and functional genomics to decode the mysteries of genetic modifiers, leading us to new medicines we'll develop for a range of severe diseases.

We are seeking an experienced Head of Clinical Development Operations who will be responsible for the planning, oversight, and conduct of clinical trials across the Maze pipeline. This individual must have the ability to work in a fast-paced, team-oriented, start-up environment to execute on Maze's clinical development plans and corporate objectives. In a highly collaborative environment, this person will lead clinical development operations for various programs entering the clinic. The position will report to the Chief Medical Officer and will be a key member of the development leadership team.

Your Navigation Tools:
  • Providing strategic and operational leadership of the clinical operations function as well as key input into the planning, design and implementation of clinical trials
  • Building and managing a clinical operations team who ensure clinical trials are conducted in accordance with study protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements
  • Developing efficient clinical trial resourcing plans, timelines and budgets
  • Interacting with patient advocacy groups to support program awareness and patient engagement
  • Identification, selection and oversight of contract research organizations (CROs) and other trial vendors and partners
  • Creating and implementing strategies for effective site selection, efficient site activation processes, and rapid patient recruitment
  • Developing fit-for-purpose SOPs, work instructions, and other clinical trial related study processes and ensuring appropriate training and adherence within the team
  • Proactively identifying risks to study execution and data quality and developing risk mitigation plans
  • Collaborating closely with key cross-functional colleagues (e.g., regulatory, clinical development, biometrics, pharmacovigilance and quality) to ensure protocols are conducted with the rigor and documentation required to support global regulatory inspections and marketing approvals
  • Collaborating closely with finance colleagues to support financial reporting and forecasting
  • Hiring, mentoring, and retaining talent to support multiple programs at various stages of development
  • Contributing to the development and maintenance of a positive team-focused company culture

Your role in Navigating The Maze:
  • BS/BA degree and at least 15 years of related experience in biotech/biopharma clinical operations or related functions
  • Demonstrated thorough understanding of GCP and ICH Guidelines governing the conduct of clinical trials, good working knowledge of FDA and EMA regulations and expertise in the execution of clinical trials, particularly those relating to rare disease settings
  • Experience in metabolic, cardio-renal, and/or neurologic disease areas is preferred
  • Experience in the oversight of early and late-stage registration-enabling clinical global clinical development programs including CRO, site, and vendor selection and relationship building with in investigators/site study staff, advocacy groups, and other third-parties
  • Experience in developing and reporting key study metrics around start-up activities, enrollment, data collection, monitoring, query resolution, and all other activities leading to timely database lock
  • Experience in writing/reviewing clinical trial documents including protocols, monitoring plans, investigational brochures, SOPs and ensuring appropriate approval and finalization
  • Experience in leveraging creative and compliant strategies for enhancing enrollment in competitive settings
  • Experience with submission of INDs, NDAs, BLAs, and/or MAAs and supporting pre-approval site and sponsor regulatory inspections
  • Technical expertise with process and tools for budget development and tracking
  • Management experience, particularly in areas team building, professional development, and mentorship of more junior staff
  • Strong leadership and communication skills to translate corporate objectives into action plans that effectively and consistently deliver high quality data on time and on budget
  • Ability to adapt quickly to changing environments and priorities
  • Positive and upbeat disposition and high personal and ethical standards in achieving corporate goals
  • Ability to travel domestically and internationally, as required, for industry conferences, meet with site personnel and collaborators