Project Leader, Preclinical & Clinical Development

Project Leader, Preclinical & Clinical Development

Pieris Pharmaceuticals

Munich, Germany

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.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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