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.

To strengthen our team in Hallbergmoos or Boston, we are looking for an experienced:

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

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, regulatory 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 including developing 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
  • This position will report to the Head of Project Leadership

Our Requirements

  • PhD degree or equivalent in Life Sciences
  • 6+ of industry experience in Biotech or Pharma
  • 4+ 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, i.e. Discovery, CMC, Regulatory Affairs, Quality, Preclinical and Clinical Development
  • 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
 
We are a fast-growing biotechnology company with approximately 130 employees at our sites in Freising (Greater Munich Area) and Boston (USA). 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 individual and company-wide goals. In addition, we offer each employee the opportunity to participate in a stock savings plan and a stock option program that allows employees to benefit directly from the company's success.
 
Numerous social benefits such as additional employer-financed company health insurance, free drinks, fruit baskets etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in our new company building in Hallbergmoos (from February 2020) round off our overall package. Creative employee events take place several times a year, as team spirit is essential for us. The joint creation of an innovative and participative corporate culture is an important concern for us.

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