Clinical Project Manager (m/f/d)

  • Pieris Pharmaceuticals, Inc.
  • Work experience
  • Fulltime
  • Published: 2021-02-11
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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.

If you are driven by learning and collaboration, embrace the thrill of success within a dynamic environment, and inspired by the opportunity to impact lives in a meaningful way, please consider joining our team!   

The Clinical Project Manager will lead, manage and be accountable for multidisciplinary clinical trial team(s) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices. This can be a REMOTE role and we will consider candidates from other states, preferably from the Northeast or Southeast part of the United States.

 

Your Tasks

  • Manage all aspects of clinical trial(s) including the selection of study vendors, oversee investigation sites, assure adherence to regulations, monitor and audit reports, and communicate with investigators and clinical project team(s).
  • Demonstrate therapeutic knowledge acting as SME assure application of best practices and following clinical protocol requirements.
  • Identify, select and manage investigation sites and study vendors.
  • Review and refine clinical operation plans including monitoring project plans.
  • Establish and manage budget, and timeliness for assigned studies.
  • Plans and conducts investigator meetings, training sessions and KOL meetings as applicable.     
  • Review clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels.
  • Works with project team as appropriate to develop the Clinical Study Report.   
  • Identifies and mitigates trial issues and/or risks.
  • Provide input together with the Clinical Project Team on responses to Health Authority questions and/or Ethics Committee/IRB.     
  • Provides or facilitates training to clinical study teams on protocol specific topics.
  • Participates in internal and external audits. 
  • Manages communication of study status and guidance to internal stakeholders. Develop Clinical Study Report, collaborate insight, knowledge and responses to various inquiries including Health Authority, Ethics Committee/IRB.

Our Requirements

  • University degree, preferable in a biologic/scientific discipline.
  • Minimum of 3-5 years R&D experience in biotech, Pharmaceutical or relevant clinical CRO experience, including 2-3 years in clinical trial management.
  • Must have knowledge of FDA regulatory requirements.
  • Experience in executing multiple phase (I-III) global clinical trials (oncology preferred).
  • Must exhibit ability to solve problems and work independently as well as work well in team
  • Strong interpersonal skills reflecting confidence, responsiveness, flexibility, and diplomacy.
  • Strong communication/presentation skills.
  • Ability to travel up to 30%.
 
 

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