Job Description Title: Associate Director, Clinical Operations Location: RemoteAbout 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 Associate Director, Clinical Operations will report to the Senior Director, Clinical Operations and will be responsible for all aspects of clinical trials management including leadership and oversight of clinical operations staff and clinical trial vendors to deliver clinical development programs within timelines, budget, and with the highest quality. Responsibilities:
- Manages multiple studies of large scope and high complexity.
- Provides leadership and therapeutic expertise for the successful management of international clinical trials.
- Mentors and trains CPM, SCTM and CTM.
- Provides leadership and therapeutic expertise for the successful management of international clinical trials.
- Contributes to the study design and strategic implementation of a clinical development program(s).
- Will be managing international clinical trials within designated program budgets and timelines is required.
- Will be engaging cross-functional groups within the company to address clinical trial issues and risks based on a detailed understanding of the issue.
- Will need to effectively communicate scientific, medical, and organizational concepts to internal and external customers and possess demonstrated knowledge of how clinical trial operations impact the broader strategic goals of the Company.
- May participate in abstract presentations, oral presentations and manuscript development.
- Developing RFPs, selection of CROs/vendors and management of external resources as required.
- Initiating and participating in and/or leading departmental or interdepartmental strategic initiatives.
- Participates in development of SOPs, Clinical Study Reports, INDs, NDAs and other clinical, regulatory and safety documents.
- Provides input into the management of the Clinical Operations department.
- Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
- Recruits, hires, mentors and manages CTM/CPM direct reports and supports their professional development.
- 10% domestic and international travel.
Qualifications:
- 8+ years of experience in clinical trials management.
- 5+ years of people management and leadership experience preferred.
- BS, BN, RN, or advanced degree in a relevant scientific discipline.
- Exceptional communication skills, both spoken and written.
- Flexible self-starter to operate in a fast-pace start-up environment. Ability to develop out of the box solutions with limited infrastructure.
- Experience is all aspects of clinical operations.
- Working proficiency with GCP, ICH guidelines and FDA regulations.
- Ability to work independently as well as collaboratively in cross-functional team 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 $165,000 - $195,000. 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. 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. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.