170 Harbor Way, 3rd Floor
South San Francisco, CA 94080
(650) 770-0077

Open Positions

Associate Director, Clinical Data Management
Learn More

Associate Director, Clinical Data Management

Location: South San Francisco, CA

Position Summary

Vera Therapeutics, Inc. is a clinical-stage biotechnology company developing innovative biologic therapeutics with transformative clinical potential. We seek a highly skilled and motivated Associate Director (AD), Clinical Data Management to join a fast-paced and collaborative team. The AD is responsible to create the infrastructure of the clinical data management (CDM) function within Vera. Additionally, the role is responsible for the planning and oversight of CDM activities, and vendor management from start-up through database lock and clinical study report within timelines, budget and with the highest quality.

Primary Responsibilities

  • Lead and manage all CDM aspects of program/study implementation from start-up through database lock and clinical study report in alignment with the clinical development program.
  • Lead, manage and oversee CDM vendor service activities in a fully outsourced model.
  • Accountable for ensuring complete, accurate, high quality clinical data for outsourced trials.
  • Lead CRF design, guidelines and standards and provide oversight and expertise into database development.
  • Development of timelines data cleaning process that maintains data integrity.
  • Manage clinical data quality plans and data transfers specifications.
  • Contribute to sponsor quality/risk management, oversight and monitoring of clinical development programs.
  • Manage and provide oversight clinical data flow with ancillary vendors including IXRS, eCOA, central lab, imaging, and other systems and services, as needed.
  • Manage and provide oversight of the CDM section of Trial Master File
  • Develop company SOP, work instructions and training for clinical data management staff. Ensure adherence with SOP, applicable regulations, GCP, and ICH guidelines.
  • May travel up to 10%, as needed, to support clinical development programs.

Qualifications

  • BS or higher in life sciences or health-related field.
  • 8+ years progressive clinical data management experience within the pharmaceutical or biotechnology industry.
  • 4+ years experience in managing, mentoring and developing junior staff.
  • Flexible self-starter to operate in a fast-pace start-up environment. Ability to develop out of the box solutions with limited infrastructure.
  • Experience is all aspects of clinical data management.
  • Working knowledge of GCP, ICH guidelines and FDA regulations.
  • Ability to work independently as well as collaboratively in cross-functional team environment.
  • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, Project).
  • Strong interpersonal skills with excellent oral and written communication.
  • Innovative, analytical and extremely organized to drive projects to completion.

Vera Therapeutics, Inc. is an equal opportunity employer.

Apply
Director/Associate Director, Clinical Operations
Learn More

Director/Associate Director, Clinical Operations

Location: South San Francisco, CA

Position Summary

Vera Therapeutics, Inc. is a clinical-stage biotechnology company developing innovative biologic therapeutics with transformative clinical potential. We seek a highly skilled Director/Associate Director (D/AD) of Clinical Operations to join a fast-paced and collaborative team. The D/AD will be responsible for directing the planning, execution and oversight of the company’s assets in all phases of clinical development programs. The D/AD provides leadership and oversight of clinical operations staff and clinical trial vendors to deliver clinical development programs within timelines, budget, and with the highest quality.

Primary Responsibilities

  • Defines the clinical operational strategy of development programs and directs the planning and execution of clinical trials from early development to market filings.
  • Accountable for clinical program/study timelines, budgets and manage actual spends to approved budget.
  • Develops clinical protocols and contributes to the writing and/or updates to the investigator brochure.
  • Contributes to the strategy and development of documents for interactions with regulatory authorities.
  • Oversees quality/risk management of clinical development programs.
  • Oversees full service CRO and vendor management activities including request for proposal, vendor selection, development of scope of work, performance management and vendor governance.
  • Oversees the development of clinical trial systems and workflows (e.g., design, specifications/requirements, UAT) including IRT/IXRS, central lab, eCOA, etc.
  • Oversees clinical supply forecasting requirements for clinical trials and collaborates in labeling/packaging, distribution and chain of custody of clinical supplies.
  • Contribute to the development, review and finalization of clinical study reports.
  • Develops company SOP, work instructions and training for clinical operation activities.
  • Ensures clinical programs are implemented in adherence to SOP, GCP, ICH guidelines and FDA regulations.
  • Generates program reports and presents clinical program strategy and status to senior management.
  • May travel up to 30%, as needed, to support clinical development programs.

Qualifications

  • BS or higher in life sciences or health-related field.
  • 10+ years progressive clinical operations experience within pharmaceutical or biotechnology industry.
  • 5+ years of people management and leadership experience.
  • Flexible self-starter to operate in a fast-pace start-up environment. Ability to develop out of the box solutions with limited infrastructure.
  • Experience is all aspects of clinical operations.
  • Working proficiency with GCP, ICH guidelines and FDA regulations.
  • Ability to work independently as well as collaboratively in cross-functional team environment.
  • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, Project).
  • Strong interpersonal skills with excellent oral and written communication.
  • Innovative, analytical and extremely organized to drive projects to completion.

Vera Therapeutics, Inc. is an equal opportunity employer.

Apply
Scientist I/II
Learn More

Scientist I/II

Location: South San Francisco, CA

Position Summary

Vera Therapeutics, Inc. is a clinical-stage biotechnology company developing innovative biologic therapeutics with transformative clinical potential. We seek a highly skilled and motivated Scientist to join a fast-paced and collaborative team. The Scientist will support the expression and purification of antibodies for early biophysical characterization, in vitro and in vivo studies. In addition, the candidate will work closely with individuals in both biology and protein chemistry groups to innovate and build the next generation of protein therapeutics.

Primary Responsibilities

  • Design and carry out protein purification to support hit to lead studies
  • Hands-on working with and developing protein purification techniques such as chromatography and tangential flow filtration.
  • Performing protein purification using affinity, ion exchange, and hydrophobic interaction chromatography using FPLC systems
  • Running and operating analytical techniques, such as chromatography, SDS-PAGE, ELISA, IEF and flow cytometry is preferred
  • Independently investigating complex analytical results and provide robust solutions
  • Prioritizing responsibilities, multi-task, and remaining flexible with changing needs
  • Analyze, interpret, and present in result summaries
  • Document results in lab notebooks and creating batch records

Qualifications

  • Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, or a closely related discipline
  • Advanced degree is preferred
  • Minimum years of relevant industry experience: Six (6) with Bachelor’s degree, four (4) with Master’s degree and two (2) with PhD
  • Experience with antibody expression and purification is a must
  • In depth knowledge of protein chemistry
  • Excellent communication (oral and written) and interpersonal skills
  • Good documentation and organization are required
  • Working knowledge of AKTA systems and Unicorn programming
  • Good statistical analysis skills
  • Must be motivated and able to work under tight deadlines

Vera Therapeutics, Inc. is an equal opportunity employer.

Apply
Full Website Coming Soon.
Top