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Vice President, Clinical Pharmacology
3 months ago
Title: Vice President, Clinical Pharmacology
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:
The Vice President, Clinical Pharmacology will report to the Chief Medical Officer and will be responsible for leading and managing the clinical pharmacology strategy, providing direction and oversight for the development and implementation of clinical pharmacology plans for our biotechnology and pharmaceutical products. Working with the Clinical Research, Medical Affairs, and PV teams, this position will work closely with regulatory agencies to ensure that our products meet all regulatory requirements and will be responsible for driving the successful development and approval of new products.
Responsibilities:
- Lead and manage the clinical pharmacology strategy, providing direction and oversight for the development and implementation of clinical pharmacology plans.
- Develop and maintain relationships with key stakeholders, including regulatory agencies, academic researchers, and key opinion leaders.
- Provide expert guidance on clinical pharmacology issues to cross-functional teams, including clinical development, regulatory affairs, and commercial teams.
- Ensure that all clinical pharmacology studies are conducted in compliance with applicable regulations and guidelines.
- Directs the activities of clinical pharmacology for clinical studies including clinical pharmacology studies.
- Collaborates with the development team on design, implementation and oversight of the conduct of clinical studies.
- Provide strategic DMPK/clinical pharmacology support and guidance to project teams.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic and pharmacodynamic data.
- Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
- May support nonclinical DMPK and PK/PD study or task.
- Keep abreast of innovative DMPK/clinical pharmacology technologies, novel pharmacokinetic and pharmacodynamic modeling approaches and regulatory guidelines with the aim of bringing therapies to patients faster or more efficiently.
Qualifications:
- PhD or MD in Clinical Pharmacology or related field.
- 10+ years of experience in clinical pharmacology and drug development.
- Prior experience in a leadership role is ideal.
- Strong understanding of regulatory requirements for drug development, including IND and NDA submissions.
- Experience with drug approvals and post-marketing surveillance.
- Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams.
- Strong analytical and problem-solving skills.
- Experience with MBDD (Model-based drug development) is a plus.
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 $ - $. 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.
this is a remote position
