Senior Clinical Trial Manager

The company the company is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company the company’ flagship commercial product is TRUTAKNA TM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand  ( APRIL) inhibitor. The company the company is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. The company the company was founded in 2016 and is based in Brisbane, California. To learn more, visit  [link for members] .

At the company, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.

Position Summary

We are seeking a highly skilled and motivated Senior Clinical Trial Manager to join a fast-paced and collaborative team.  The Senior Clinical Trial Manager will be responsible for the day-to-day operational oversight of assigned trial(s) in accordance with the protocol, standard operating procedures (SOPs) and GCP/ICH guidelines to support successful execution of the trial within timelines, budget and with the highest quality.

Responsibilities

• Manage all clinical operational aspects of a global clinical trial including start-up, conduct and close out activities.

• Monitor assigned trial for adherence to the GCP, protocol, SOPs and other key performance indicators (e.g., review of monitoring reports, study tracking tools, etc.) to ensure proper oversight of the CRO and sites.

• Proactively identifies potential study issues/risks and recommends/implements solutions.

• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serves as the primary CRO/vendor contact.

• Supports the CRO to ensure quality and accurate data is generated and assists in resolving any issues (e.g., subject eligibility, deviations, etc.) .

• Manages study timelines to align with corporate and cross-functional goals.

• Contribute to the writing, review and finalization of protocols or components of clinical study reports.

• Prepares metrics and updates for the company management.

• Organizes and leads clinical operational meetings.

• Organizes and leads study team meetings.

• Develop and maintain strong working relationships with principal investigators, key clinical opinion leaders and sites.

• May contribute to development of RFPs and participates in selection of CROs/vendors as well as review of any CRO budgets and /or change orders.

• Develop strong cross-functional relationships and exhibits leadership skills with counterparts to ensure efficient execution of clinical trial.

• Ensure site and CRO adherence with SOP, applicable regulations, GCP, and ICH guidelines.

• Contributes to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, system specifications, etc.

• Attend and/or present at Investigator Meetings as needed.

• May travel up to 30%, as needed, to support clinical development programs.

Qualifications

• BS or higher in life sciences or health-related field.

• 5+ years clinical development experience and progressive experience in clinical research within the pharmaceutical or biotechnology industry.

• Rare disease and inflammatory diseases and/or difficult enrolling study experience preferred.

• Regulatory filing and experience with inspection readiness preferred.

• Experienced in managing, mentoring, and developing junior staff.

• Flexible self-starter to operate in a fast-paced start-up environment.  Ability to develop out of the box solutions with limited infrastructure.

• Experience is all aspects of clinical operations.

• Working proficiency of GCP, ICH guidelines and FDA regulations.

• Ability to work independently as well as collaboratively in cross-functional team environment.

• Proficiency with MS Office (e.g., Word, Excel, PowerPoint, Outlook, Project).

• Strong interpersonal skills with excellent oral and written communications.

• Innovative, analytical, and extremely organized to drive projects to completion.

The company the company Inc. is an equal-opportunity employer.

The company the company is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. 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.

For this role, the anticipated base pay range is

$150,000 — $180,000 USD

At the company, 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. The company the company 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 the company the company 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.

The company the company’ 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 the company the company and such organization and will be considered unsolicited and the company the company 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 the company the company, recruiters only direct candidates to apply through our official career page at  [link for members] .

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 the company the company, please email human resources.

CA Privacy Notice

Applicants residing in California should review our California Privacy Notice for Employees, Job Applicants, and Contractors, which describes the categories of personal information we collect, how we use it, and your privacy rights under the California Consumer Privacy Act, as amended by the California Privacy Rights Act:  [link for members] .