Vice President, Clinical Operations

Title: Vice President, Clinical Operations

Location: Brisbane, CA

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 Vice President, Clinical Operations is responsible for clinical operations and other functional groups (as needed), and their deliverables to Vera’s clinical development programs. They will be a member of product governance teams, providing strategic and operational leadership for the development of the company’s assets within budget, timelines, regulatory adherence and quality standards.

Responsibilities:

• Responsible for the clinical operational strategy, plans and implementation of clinical development programs.
• Oversee and manage the staff of clinical operations and other functional groups (as needed) in the management of clinical trials in adherence to national and international regulations (e.g., ICH GCP, FDA CFR).
• Provide functional expertise and strategy to product governance teams and contribute to clinical and regulatory documents (e.g., IND, protocols, IB, regulatory interactions, BLA, CSR, publications, etc.).
• Evaluate hypotheses, objectives, study design, operational feasibility, regulatory requirements, for the clinical studies and oversee protocol development and execution.
• Develop clinical timelines, budget forecasts, and ensure accountability for tracking of deliverables.
• Oversee the evaluation, selection, scope of work and performance of CROs and ancillary clinical vendors.
• Lead resource management, support talent acquisition and onboarding, and develop functional staff including performance reviews, coaching and succession planning.
• Develop strong relationships with key opinion leaders and clinical investigators.
• Lead the development of clinical operations and applicable functional SOPs, work instructions and departmental initiatives.
• Evaluate and oversee the development of clinical systems (e.g., CTMS, eTMF, IRT) including specifications, functionality, documentation and implementation.
• Oversee clinical trial material forecast and needs for clinical trials.

Qualifications:

• BS, BN, RN, or advanced degree in a relevant scientific discipline.
• 15+ years of experience in clinical operations and clinical trials management.
• 12+ years of people management and leadership experience preferred.
• Exceptional communication skills, both spoken and written.
• Flexible self-starter to operate in a fast-paced start-up environment.
• Ability to develop out of the box solutions with limited infrastructure.
• Experience is all aspects of clinical development and clinical trials management.
• Proficiency with GCP, ICH guidelines and FDA regulations.
• Ability to work independently as well as collaboratively in cross-functional team environment.

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 $315,000 - $363,000. 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.

Fraud Alert

To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.

Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.

Last updated on Oct 15, 2024