BioSample Manager (m/f/d)

  • Pieris Pharmaceuticals, Inc.
  • Work experience
  • Published: 2021-04-19
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Pieris Pharmaceuticals (Nasdaq: PIRS) is a clinical-stage biotechnology company with operations in Germany and the United States. Pieris discovers and develops Anticalin┬« protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. It is our mission to develop life-changing therapeutic proteins for patients suffering from cancer and respiratory  diseases through the innovative application of novel science and cutting-edge technologies.

The BioSample Manager (BSM) will be the point of contact and functional lead for all operational activities relating to vendor and sample management to deliver quality samples used in evaluating the drug efficacy and pharmacokinetics. This role is an integral part of the study team during study startup, live phase, and closeout and contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.  

 

Your Tasks

  • Ensures standardization and harmonization of BioSample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation, maximizing BioSample sample accrual and quality.
  • Coordinates with internal team (clinical operations and translational/biomarkers) in determining sample flow.
  • May support clinical, preclinical and discovery samples.
  • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors.
  • Works with Procurement to execute lab contracts.
  • Reviews and finalizes the lab SOW and ensures all stakeholders are involved for the review.
  • Identifies stakeholders for questions impacting analysis and custody of samples and escalates issues to internal and external parties to ensure a timely resolution.
  • Addresses questions from the CRO, repository or clinical site on sample collections.
  • May participate in vendor negotiations, product and software evaluations, implementations, and management.
  • Develops procedures and plans.
  • Mentors junior team members.
  • Within Clinical Operations ensures completion and accuracy of the Clinical Sample Management Plan.
  • Creates/utilizes tracking systems to report progress, address issues and resolutions.
  • Oversees studies of moderate to high complexity.
  • Leads meetings which ensures needs of the samples are correct.
  • Possesses solid understanding of clinical trial lifecycle and be able to update team members of sample process, collection, analysis, and results in team meetings.
  • Identifies, escalates, and resolves complex issues.

Our Requirements

  • Bachelor's or equivalent experience; an advanced degree a plus.
  • 4+ years of experience with at least 2 years managing CROs.
  • Hands-on experience managing multiple laboratory vendors, including central, analysis and repository laboratories.
  • Previous clinical BioSample management experience is required, preferably in oncology.
  • Experience and understanding of ICH and GXP is required.
  • Familiar with processes and restrictions of vendors.
  • Ensures compliance with regulatory agency documentation and reporting requirements.
  • Demonstrated ability to solve problems.
  • Strong written and verbal communication skills.
  • Experience working within a highly matrix environment while managing stakeholder expectations and requirements.
  • Must be a self-starter and team player with strong interpersonal skills.
  • Must possess effective project management skills.

Pieris is a fast-growing biotechnology company with approximately 130 employees across our sites in Munich, Germany and Boston, United States. We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of our company goals. In addition, we offer each employee the opportunity to participate in a stock purchase plan as well as a stock option program that allows Pieris employees to benefit directly from the our success.
 
Numerous social benefits such as an additional employer-financed company health insurance, free drinks etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in both of our locations round off our overall package. Creative employee events take place several times a year, as we believe that a healthy spirit of collaboration is key to our success.

Pieris Pharmaceuticals, is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
 

How to reach us

Pieris Pharmaceuticals, Inc.
255 State Street, 9th floor
Boston, MA 02109
USA
+1 (857) 246-8998