Executive Director, Translational Research Biology

Title: Executive Director, Translational Research Biology

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 Research, to join an experienced, fast-paced and collaborative team at Vera Therapeutics to lead non-clinical translational research activities. The position will report to the Senior 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, including Research, Translational Medicine, Clinical Pharmacology, Bioanalysis, Chemistry Manufacturing and Controls (CMC), Quality Assurance, Regulatory, and Project Management, and with CROs, to conceive therapeutically relevant hypotheses, and drive IND-enabling studies that inform indication and patient selection strategies to support subsequent clinical development. Key deliverables will include authoring relevant sections of the IND package describing mechanistic activities, and leading analyses of nonclinical datasets to inform identification of target diseases, dose, combinations, and predictive biomarkers to accelerate and optimize the development of Vera’s drugs. The individual will collaborate closely with Translational Medicine to back-translate findings from the clinic into nonclinical studies to inform new development opportunities.

Responsibilities:

• Generate testable hypotheses that are aligned with business needs and add value to drug-development programs.
• Work with CROs to supervise in vitro and in vivo pharmacology studies supporting Vera’s INDs.
• Lead pharmacology and toxicology analyses for IND enabling studies.
• Collaborate with Research, Toxicology, CMC, Clinical Pharmacology, Bioanalysis, Project Management, CMC, and Regulatory to deliver IND packages.
• Collaborate with Translational Medicine to generate testable hypotheses and open research questions and implement studies to inform these questions.
• Participate in selection of testing vendors and provide input on timelines, budget, etc.
• 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.
• Engage in complex and large-scale deliverables and initiatives to ensure consistently successful and timely execution.
• Deliver more than 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.
• Help shape the organization and positively influence our culture.

Qualifications:

• PhD in biology, pharmacology, or immunology with 12+ years of experience in pharma/biotech with strong scientific acumen and experience in biologics development.
• Experience in chronic diseases, especially autoimmune or inflammatory diseases, is desired.
• Experience in regulatory activities is required, including authoring reports and relevant sections of regulatory documents, and engagement with regulatory agencies.
• Experience in bringing programs to the clinic, including supporting IND applications.
• Demonstrated experience in developing and implementing nonclinical studies to inform drug development, biomarker discovery, and strategies to inform drug development.
• Intellectual agility, strong planning skills, scientific leadership, and ability to drive projects forward is required.
• Experience in collaborating with cross-functional teams, global CROs, academics and partner companies.
• Experience in translational research and developing biomarker identification strategies is strongly desired.
• Record of high-quality publications and/or public presentations.
• Proven track record of achieving complex strategic goals and objectives despite highly challenging circumstances.
• Commitment, drive, and ownership mindset.
• Strong interpersonal skills to establish and maintain positive relationships with internal teams, external vendors and key opinion leaders, promoting collaboration and partnership.

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 begins at $250,000. 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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