Director, Bioanalytical Sciences

Title: Director Bioanalytical Sciences

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 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 auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN). In addition 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:

We are seeking a Director Bioanalytical Sciences to join an experienced fast-paced and collaborative team at Vera Therapeutics. The position will report to the Executive Director Bioanalytical Sciences and will be part of the PK immunogenicity and biomarker assay development and validation function at Vera Therapeutics. The individual will be a key contributor to all aspects of bioanalytical assays for our antibody and fusion protein products. Working with key stakeholders in the Clinical Pharmacology and Analytical Sciences teams and key personnel from functions including Clinical Research Clinical Operations Biostatistics Quality Assurance Regulatory and Project Management and with CROs this individual will establish robust bioanalytical methods to support clinical studies and enable global regulatory approvals of our products.

Responsibilities:

• Work with the clinical research team to design and execute bioanalytical aspects (e.g. PK ADA and biomarkers) of clinical studies.

• Work with CROs to develop validate and maintain bioanalytical methods supporting Vera’s clinical studies.

• Review validation protocols test procedures raw data and technical reports to ensure scientific integrity and compliance with regulatory requirements.

• Collaborate with Clinical Operations Clinical Data management and Biostatistics functions to ensure timely collection of high-quality data to support clinical studies.

• Represent the bioanalytical function to various cross-functional groups

• Author memos protocols reports and analytical sections for regulatory filings.

• Participate in selection or CROs and provide input on timelines budget shipments and inventory managements.

• Support Quality audits deviations and troubleshooting activities.

• Engage in complex and large-scale deliverables and initiatives to consistently successful and timely execution.

• Deliver more than is expected by driving a culture of innovation novel thinking and continuous improvement across own area that serves as a model for other areas across own function to follow.

Qualifications:

• PhD in Chemistry Biochemistry or related discipline with 4+ years of experience in pharma/biotech with strong scientific acumen and experience in the field of bioanalysis and biomarkers.

• Demonstrated expertise in PK assay development validation by hybrid LBA-LC-MS/MS methods AND substantial experience in ADA assay development and validation.

• Experience in bioanalytical interpretation of immunogenicity results.

• Expertise in development and validation ligand binding and cell-based neutralizing assays.

• Ability to troubleshoot complex assays in real time.

• Experience authoring and reviewing methods validation protocols and reports and regulatory filings in particular authoring relevant sections of BLA.

• Solid expertise in the interpretation and application of international regulatory guidelines for bioanalytical methods.

• Wide-ranging experience managing global CROs including in China.

• Expertise with biomarker discovery for kidney/autoimmune disease is strongly desired.

• Proven track record of achieving complex strategic goals and objectives despite highly challenging circumstances.

• Helps shape and positively influence our culture.

• Excellent interpersonal skills and demonstrated ability to work well in a team-oriented 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 $194000 - $224000. 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.

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