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Biologist - Clinical Project Management, Biotechnology (m/f/d) job in Hallbergmoos bei Pieris Pharmaceuticals GmbH

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Biologist - Clinical Project Management, Biotechnology (m/f/d) bei Pieris Pharmaceuticals GmbH

Biologist - Clinical Project Management, Biotechnology (m/f/d)

Pieris Pharmaceuticals GmbH Hallbergmoos, Bayern Vollzeit
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Senior Clinical Project Manager (m/f/d)

Permanent employee, Full-time • Hallbergmoos

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.
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.

Your Tasks

The Senior Clinical Project Manager will be a key member of the Pieris Clinical Operations team, responsible for leading clinical trial implementation teams and having oversight of assigned Contract Research Organizations (CROs), laboratory vendors and assigned clinical trial service providers. The Senior Clinical Project Manager plans and manages overall clinical operations for assigned clinical trials / programs including timelines, budgets, resources, investigational sites, vendors and key project deliverables.

  • Leading and managing multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
  • Oversees the preparation and management of clinical trial site budgets; establishes project milestones, budgets and timelines for the study conduct together with the study team and establishes a detailed project plan
  • Follow-up and monitor the recruitment rate of the study and take appropriate and timely corrective actions, as needed
  • Maintain therapeutic knowledge and a high level of professional expertise through familiarity with clinical protocols and projects as appropriate
  • Responsible for managing and selecting study vendors and investigation sites for assigned studies
  • Reviews and refines clinical operation plans including monitoring project plans
  • 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
  • Provide input together with the Clinical Project Team on responses to Health Authority questions and/or Ethics Committee / IRB
  • Manages the development of in-house operations SOPs, guidelines and systems to ensure compliance and alignment of all processes and procedures
Our Requirements
  • University degree, preferable in a biologic / scientific discipline
  • Ideally a minimum of seven to ten years R&D experience in biotech, Pharmaceutical or relevant clinical CRO experience, including more than five years in clinical trial management
  • Experience in executing multiple phase (I–III) global clinical trials in Oncology
  • Secondary experience in respiratory a plus
  • Knowledge of FDA regulatory requirements
  • Ability to solve problems and work independently as well as work well in team environment
  • Demonstrated multi-tasking ability, managing multiple, conflicting priorities effectively
  • Strong interpersonal skills reflecting confidence, responsiveness, flexibility and diplomacy
  • Exceptional leadership skills including ability to lead, manage conflict, manage change, influence and manage teams
  • Strong communication / presentation skills
  • Excellent written and oral communication skills, strong computer skills, (Excel, Word, PowerPoint, MS Project) and solid presentation skills are essential
  • Ability to travel global and domestically up to 30 %
Why us?

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.

 
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Job ID: 163426