Clinical Program Manager

2 weeks ago

Brisbane, United States Vera Therapeutics Full time
Job DescriptionJob Description

Title: Clinical Program Manager

Location: Remote

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.


Position Summary:

The Clinical Program Manager (CPM) will report to the Senior Director of Clinical Development and will be responsible for oversight and execution of up to three clinical studies in various stages of development. Working with a cross functional team and key personnel including Biostatistics, Regulatory, Clinical Supply Management, Finance, Clinical Research and others, will ensure the study(ies) are brought in on time and on budget while communicating effectively status, risks, and updates to the teams.

Responsibilities:

  • Manages and has oversight of an entire clinical trial(s) to ensure corporate goals are met.
  • Leads cross-functional teams internally and externally.
  • Incorporates study logistics, processes and planning to accomplish study objectives.
  • Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
  • Must be able to understand, interpret and explain protocol requirements to others.
  • Maintains study timelines.
  • Assists in determining the activities to support a project’s priorities within functional area.
  • Contributes to development of RFPs and participates in selection of CROs/vendors.
  • May be asked to train CROs, vendors, investigators and study coordinators on study requirements.
  • Contributes to development of study budget.
  • May serve as a resource for others within the company for clinical trials management expertise.
  • Provides input into the management of the Clinical Operations department.
  • Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
  • Excellent interpersonal skills, ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required.
  • Recruits, hires, mentors and may manage direct reports and supports their professional development.

Qualifications:

  • BS, BA, RN or advanced degree in a relevant scientific discipline.
  • 8+ years of clinical operations experience.
  • Excellent communication skills, both spoken and written.
  • Experienced in managing, mentoring and developing junior staff.
  • Flexible self-starter to operate in a fast-paced start-up environment.
  • 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 a cross-functional team environment.
  • Innovative, analytical and extremely organized to drive projects to completion.
  • Working knowledge of MS Suite.


Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is starting at $155,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.


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