Senior Director, Clinical Research
Clinical | Remote | Full Time
Title: Senior Director, Clinical Research
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 Senior Director, Clinical Research will report to the Vice President of Clinical Research and will be responsible for leading the development of clinical research programs in nephrology, rheumatology, and infectious diseases. Working with the Clinical Research team, this highly skilled and team-oriented Medical Director will be a physician and will either have subspecialty training or prior drug development experience in Nephrology or Infectious Disease or Rheumatology and have at least 2 years of clinical research and development experience. We seek a high-integrity colleague who is values-driven and seeks to improve medical care through innovative drug development.
Responsibilities:
- Serves as an independent Medical Monitor for clinical trials from Phase 1 through Phase 3 by articulating clinical development strategy.
- Analyzing, interpreting, and acting on clinical trial data to support development.
- Serving as principal functional author for Regulatory submission, study reports, and publications.
- Provides oversight and medical accountability for multiple trials across early development clinical lifecycle.
- Manages site interactions in partnership with the Clinical Scientist for medical questions and education.
- Assesses key safety-related serious adverse events in partnership with Global Safety and oversees contributions to safety narratives.
- Strong presentation skills for internal and external (Investigator meetings, DMCs, Steering Committee) communications.
- Accountable as a key medical and scientific leader.
- Represent the medical and scientific integrity of the company, leading science-driven product development and informing clinically related corporate decisions.
- Lead our clinical program in a multinational, randomized controlled Phase 2b or Phase 3 trial.
- Ensure clinical programs meet required quality and safety standards.
- Medical review of clinical documents submitted to regulatory agencies.
- Participate in meetings with regulatory agencies as medical program leader.
- Lead publication strategy in close collaboration with relevant internal functions.
- Lead interactions and build trustful relationships with medical and scientific advisors, building. and maintaining relationships consistent with development and commercial objectives.
- Keep track of and share the impact of trends in related areas of medicine and science.
- Represent Vera’s clinical program to the medical community, Advisory Boards.
Qualifications:
- M.D. with relevant medical experience in Nephrology or Infectious Disease or Rheumatology.
- 5+ years of experience in pharma/biotech industry.
- Proficient in efficient design, conduct, interpretation, and presentation of late-stage trials.
- Excellent written and verbal communication.
- Experience with pediatric programs a plus.
- Experience with transplant programs a plus.
- Experience with filing an NDA and BLA a plus.
- Team player and team leader, anticipates the needs of colleagues.
- High level of maturity, and ability to exercise good judgement, discretion, and confidentiality.
- High motivation to make a difference.
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 $307,000. 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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