Associate Director, Clinical Operations

Location
San Francisco, CA
Posted
Nov 29, 2018
Required Education
Bachelors Degree
Position Type
Full time

Summary

The Associate Director, Clinical Operations will manage clinical trials as part of the clinical operations team. S/He will be involved in the daily operations of Spruce Biosciences’ clinical programs through vendors and through Spruce’s own activities. This person may drive a program, study or lead a team of clinical operations professionals and will be expected to provide vision, leadership, and mentoring to their assigned team.

The Associate Director, Clinical Operations will manage clinical trials in coordination with other functions. S/He will be involved in the daily operations of Spruce Biosciences’ clinical programs through vendors. There is potential that this person in time will lead a team of clinical operations professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. S/he must have an expert and comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards.  Under the direction of the VP, Development Operations, s/he is responsible for clinical trial management through CROs, oversight and successful execution of Spruce Biosciences’ clinical trials according to regulatory guidelines.  S/he must facilitate effective internal and external relationships.  S/he is responsible for achievement of project goals and objectives on time and on budget.

Specific Responsibilities

  • Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a flexible clinical operations team.
  • Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials
  • Provide direction and leadership in CRO and vendor selection and management.
  • Knowledge of regulatory start up process and planning in support of study start up
  • Building, managing, and maintaining high performing clinical teams
  • Contribute to strategic planning to ensure optimized clinical development plans for assigned projects.
  • Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
  • Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
  • Be responsible for and manage clinical research activity of Clinical Trial Managers, Clinical Trial Specialists and contract CRAs.
  • Prepare clinical research budgets and timelines
  • Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs

Qualifications

  • Bachelor’s degree required with 5 years + of experience
  • Proven experience in the pharmaceutical or biotechnology industry

Preferred Experience, Special Skills, Knowledge:

  • Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
  • Rare Disease experience
  • Recruitment methodologies and innovation
  • Demonstrate experience of study start up and vendor oversight
  • Demonstrated experience managing and mentoring clinical team members.
  • Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
  • Must have extensive experience managing CROs, central laboratories, and other clinical study vendors.
  • Must have a working knowledge of data management, data review and analysis, and drug safety and Pharmacovigilance.
  • Ability to work on and solve complex problems.
  • Ability to prioritize and handle multiple tasks simultaneously.
  • Effective leadership skills and proven ability to foster team productivity and cohesiveness.
  • Excellent communication/interaction skills and experience in a dynamic and growing organization.
  • Travel Required
  • Bullet points of additional skills and characteristics required for this position

About Spruce Biosciences

Spruce is driven by a mission to develop meaningful therapies for patients with rare diseases. Our growing team brings a diverse history of drug development experience, scientific and medical expertise, effective company leadership, and spirited collaboration.

As we expand, we continue to welcome passionate and talented individuals who share our desire to create new possibilities in medicine.

Spruce offers a competitive compensation package and a rewarding work environment. Join an up-and-coming biotech company in San Francisco fostering innovation, collaboration, and ultimately a streamlined approach to drug development.

If you think Spruce may be the right place for you, please submit your resume/CV.

Spruce Biosciences is an Equal Opportunity Employer.

Principals only; no recruiters please.