Project Leader (m/f/d), Clinical Development

  • Boston
  • Hallbergmoos
  • Fulltime
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Pieris Pharmaceuticals (Nasdaq: PIRS) is a publicly-traded, clinical-stage biotechnology company with operations in Germany and the United States. Pieris specializes in the discovery and development of 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, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.

Your Tasks

  • Lead one or more cross-functional project teams in a matrix environment. 
  • Develop the project strategy, set up an integrated cross-functional development plan (including CMC, regulator and preclinical activities as well as clinical protocol design; including budget and FTE needs), coordinate all IND-enabling activities to achieve IND submission and lead the team to initiate and conduct clinical studies. 
  • Monitor project progress, timelines, budget, resource allocation and risks. Develop mitigation plans and corrective actions should deviations occur. 
  • Collaborate effectively with CMOs, CROs, regulatory agencies, key opinion leaders, clinicians and external partners. 
  • Within our matrix environment, closely interact with functional area heads, group leaders and lead scientists from the different R&D departments.
  • Act as central point of communication for your project(s).  
  • Report project progress to Pieris’ Senior Management and lead projects through Pieris’ governance committees and review processes.  

Our Requirements

  • PhD degree or equivalent in life sciences. 
  • Six or more years of industry experience in the life sciences industry (biotechnology or pharmaceutical company experience preferred).  
  • Four or more years of experience in leading cross-functional project teams in a matrix. 
  • Advanced project management skills. 
  • High degree of interpersonal skills with an ability to work effectively with multiple stakeholders.
  • Thorough understanding of all aspects of drug development, including CMC, regulatory affairs, quality assurance and clinical studies.  
  • Ability to strategize, prioritize, and manage projects to ensure quality, timely, on-target and within budget accomplishment of tasks as well as planning for resource needs.  
  • Team player with excellent communication skills in English (oral and written). 
  • Proven ability in leading IND enabling and clinical projects and working with external partners.
  • Experience in the discovery and manufacturing of therapeutic proteins (i.e. antibodies and / or scaffold proteins), in health authority interactions, in regulatory submissions, in preclinical or clinical operations and in respiratory disease and immuno-oncology is a plus.

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.
 

We look forward to receiving your application via
Mr. Graham Johnson (Coulter:Partners); E-Mail: pieris@coulterpartners.com