Director of Clinical Assays

Director of Clinical Assays
Redwood City, CA
We are seeking a full-time Director of Clinical Assays to perform a range of technical, operational, and project management activities in support of assays for ongoing and upcoming sponsored clinical studies. Reporting to the CSO, this individual will direct both internal and external clinical assay development, performance, and deliverables. The Director will take responsibility for managing the interdepartmental collaboration between R&D, clinical development, clinical operations, and business operations to ensure these activities are performed appropriately and on time. The ideal candidate should have a strong interest in learning about our pipeline programs and be a team player that shares the founders' passion in bringing these vaccines to patients. Preference will be given to candidates with previous experience in the below core responsibilities and functions.

The applicant should be responsible, self-motivated, possess a high level of integrity, resourceful, and driven to maintain high quality deliverables. The successful candidate will be flexible and able to work in a fast-paced start-up environment. They should be capable of multi-tasking, independently managing responsibilities, and prioritizing action items based on company goals. The candidate should be eager to learn new topics and processes. Strong written and oral communication skills, and the ability to effectively organize work are required.

Key responsibilities
  • Directing all aspects of our clinical assays and ensuring their success while meeting clinical timelines.
  • Supervising internal and external teams responsible for development and performance of clinical assays.
  • Manage proper transfer of clinical assay data from performing laboratories to Biometrics.
  • Oversee assay qualification and validation of in-house and externally performed clinical assays.
  • Assist the R&D team with selection of new clinical assays and vendors, including diligence on quality and compliance. Drive budget and contract negotiations to execution in collaboration with management.
  • Track and evaluate timelines for clinical assay development and identify risks that require timeline adjustment or other interventions or escalations.
  • Direct the tech transfer of clinical assays from one performance site to another.
  • Contribute to selection of clinical assays and corresponding specimen types during trial design.
  • Author and QC the clinical assay sections of investigator brochures, clinical study protocols, clinical study reports, regulatory submissions, and other key clinical/regulatory documents, with collaboration from R&D, Clinical Development, Clinical Operations, and Regulatory Affairs teams.
  • Work closely with Director of Clinical Operations and VP of Operations to ensure proper inventorying and processing of clinical trial samples.
  • Provide archival support to ensure proper storage and retrieval of clinical test results, memos, and other clinical trial records regarding the assays.
  • Provide regular updates to management team, vendors, and contract staff on the status and progress of performance and analysis of clinical assays
  • Monitor trial progress and performance with a focus on clinical assay timelines.
  • Evaluate central laboratory scopes of work and budget proposals and associated financial metrics.
  • Support the team's forecasting of clinical assay-related impacts to overall company budget.
  • Work with QA and Clinical Operations on inspection and audit readiness pertaining to clinical assays.
Qualifications, Experience, and Skills
  • PhD degree in virology, immunology, microbiology, molecular biology
  • Industry experience (minimum 8-10 years)
  • Prior experience managing teams, including managing scientists, vendors, and CROs.
  • Familiarity with assays utilized on sponsored clinical trials (e.g., microneutralization assays, plaque assays, RT-PCR, sequencing).
  • Prior laboratory experience and familiarity with fundamentals of clinical assay requirements such as acceptance criteria, specificity, sensitivity, critical reagents, and reference standards.
  • Familiarity with specifications and requirements of human sample collection such as nasal swabs, PBMCs, and sera.
  • Prior experience with cross-functional collaboration, for instance with clinical operations and other functions, on teams conducting clinical trials.
  • Self-starter that is good at identifying and addressing process gaps. Build new processes as needed by authoring appropriate SOPs.
  • Proficiency in using project management tools to organize programs and activities across functions.
  • Has a proactive approach to risk mitigation and problem-solving mentality.
  • Enjoys dynamic, rapidly changing work environments.
  • Clear and persuasive written and oral communication skills.
  • Ability to prioritize and drive team decisions.
  • Commitment to being on-site at our headquarters.

Job Details

Job Type: Direct Placement
Location: Redwood City, CA
Job ID: 20-08329
Date Updated: November 24, 2020