Executive Director - Bioanalytical Sciences

Title: Executive 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 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:

We are seeking an Executive Director Bioanalytical Sciences to join an experienced fast-paced and collaborative team at Vera Therapeutics. The Executive Director (ED) Bioanalytical Sciences will report to the VP of Clinical Pharmacology and Translational Medicine and will lead the PK immunogenicity and biomarker assay development and validation function at Vera Therapeutics. The ED will lead all aspects of our bioanalytical assay establishment 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.

• Lead selection or CROs and provide oversight over timelines budget shipments and inventory management.

• Support Quality audits deviations and troubleshooting activities.

• Able to steer highly complex and large-scale deliverables and initiatives to consistently successful and timely execution.

• Able to 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.

• Owns the short- and long-term strategy roadmap and resource plans for bioanalytical.

• Plays a leadership role in contributing to the definition of multi-disciplinary strategies for Vera’s key projects.

Qualifications:

• PhD in Chemistry Biochemistry or related discipline with a minimum of 14 years of experience in biopharma with an exceptional scientific acumen and proven track record of leadership in the field of bioanalysis and biomarkers.

• Extensive experience in the design and management of bioanalytical studies for protein therapeutics.

• Excellent expertise in developing validating troubleshooting and maintaining bioanalytical methods for recombinant protein therapeutics.

• Proven experience establishing regulated assays for PK ADA Nab and biomarkers.

• Proven effectiveness in leading teams developing new and novel bioanalytical strategies and capabilities.

• Able to anticipate and influence the future of bioanalytical filed and advance the function's longer-range strategies and capabilities.

• Acts as a 'trusted advisor' across Vera and recognized as an expert in the bioanalytical field.

• World-class technical background in ligand-binding assays LC-MS and other bioanalytical techniques.

• 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.

• Experience with recombinant protein analytical characterization is highly desirable.

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

• Uses significantly advanced EQ to effectively lead complex strategies and teams through periods of large scale change or considerable ambiguity.

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

• Creates an inspiring environment in which team members feel motivated consistently leading others in a manner that enhances team morale and collaboration.

• Helps shape and positively influence our culture.

• Develops future leaders within his/her reporting structure as well as in a matrixed environment.

• 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 $220000 - $266000. 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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