Executive Director, Translational Medicine

Title: Executive Director, Translational Medicine

Location: Brisbane, CA

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and 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, Translational Medicine, to join an experienced, fast-paced and collaborative team at Vera Therapeutics. The position will report to the Vice President, Clinical Pharmacology and Translational Medicine and will be part of the clinical pharmacology, bioanalysis and translational medicine function at Vera Therapeutics. The individual will work with key stakeholders within the function and cross-functionally with Clinical Development, Clinical Operations, Biometrics, Quality Assurance, Regulatory, and Project Management, and with CROs, to drive Translational Medicine strategy and implementation to support clinical studies and enable global regulatory approvals of our products. Key deliverables will include generating hypotheses to identify target-engagement, pharmacodynamic and predictive biomarkers to characterize the mechanisms of action of Vera’s drugs. Additionally, the Executive Director, Translational Medicine will conduct data analysis to integrate translational and pharmacologic findings with an understanding of disease biology to inform optimal treatments for patients including identification of potential future therapeutic combinations and additional disease indications. Finally, the individual will drive efforts to back-translate from clinical and biomarker findings to inform the design of new/second generation drugs.

Responsibilities:

• Work with the clinical research team to design and execute translational medicine strategies for clinical studies.
• Collaborate with Clinical Operations, Clinical Data management, and Biometrics functions to ensure timely collection of high-quality data to support clinical studies.
• Lead biomarker data analysis efforts in conjunction with Clinical Pharmacology, Biostatistics, and Clinical Development functions.
• Participate in selection of testing vendors and provide input on timelines, budget, etc.
• Work with CROs to supervise development, validation, and maintenance of biomarker methods supporting Vera’s clinical studies.
• Review protocols, test procedures, raw data, and technical reports to ensure scientific validity and compliance with current regulatory requirements.
• Establish and maintain strong external partnerships with key opinion leaders, academic institutions and other external partners.
• Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.
• Support business development and licensing evaluations.
• Support Quality audits 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 Immunology with 12+ years of experience in pharma/biotech with strong scientific acumen and experience in the field of biomarkers/translational medicine.
• Industry experience is required. B-cell expertise is a plus.
• Regulatory submission experience is required, particularly past experiences in reviewing methods and validation protocols and authoring reports and relevant sections of BLA.
• Demonstrated experience in developing and implementing biomarker strategies to inform drug development (e.g. support dosage recommendations, verify MOA, identify predictive or prognostic effects).
• Demonstrated expertise in clinical application of various immune monitoring assay modalities including platforms for cytokine quantification (e.g. O-Link or MSD), gene expression (e.g. Nanostring) and multi-parametric flow cytometry (Full Spectrum &/or CyTOF).
• Strong expertise in leading the development, validation and implementation of assays using modalities above.
• Record of high-quality publications and/or public presentations focused on immunology, autoimmune disorders or kidney disease.
• Ability to troubleshoot complex assays in real time.
• Wide-ranging experience managing global CROs.
• Expertise with biomarker discovery for autoimmune &/or kidney disease is strongly desired.
• Proven track record of achieving complex strategic goals and objectives despite highly challenging circumstances.
• Strong interpersonal skills to establish and maintain positive relationships with internal teams, external vendors and key opinion leaders, promoting collaboration and partnership.
• 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 $250,000 - $270,000. 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.

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

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