Medical Director (m/f/d), Clinical Development

  • Pieris Pharmaceuticals GmbH
  • Hallbergmoos
  • Manager First Level
  • Research, development, teaching
  • Fulltime
  • Published: 26.08.2020

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

  • Leading and coordinating study activities in the assigned program/indication in collaboration with the Clinical Project Managers (CPM)
  • Contribution to the development of the Clinical Strategy/Clinical Development Plan in collaboration with Senior/Executive Medical director and Head of Clinical development and provide medical oversight into protocol development, study conduct and data generation, as well as reporting for the assigned program.
  • Oversee assigned program as medical monitor to ensure that regulatory requirements and quality standards are met. Strive to maintain or exceed compliance obligations for Good Clinical Practices guidelines and standard company operating procedures.
  • Support Senior/Executive Medical director and Head of Clinical Development as a company representative interacting with external scientific leaders and regulatory authorities for assigned program(s).
  • Reviewing and writing  abstracts or manuscripts for publications and presentation 
  • Co-leading investigator meetings and advisory committee meetings 
  • Lead strategic reviews and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with clinical development program. 
  • Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol.
  • Co-lead product safety review committees as appropriate.
  • Provide consultation on medical subjects to investigators and other company personnel, and apply medical knowledge to guide the safe, ethical, and efficient conduct of trials.
  • Participate in due diligence efforts for clinical partnerships and in-licensing opportunities
  • Work with specific clinical and research partners to facilitate seamless execution of collaborative efforts.

Our Requirements

  • Degree as Doctor of Medicine or equivalent
  • Board-certification (or local equivalent) in oncology/hematology. Demonstrated potential or ability to design, initiate, and conduct clinical studies.
  • Proven experience as medical monitor in academia, industry or CRO, experience in either early stage or late stage oncology clinical trials or required
  • Proven ability to analyze and interpret efficacy and safety data relating to oncology.
  • Able to work across many interfaces (clinical/clinical operations, clinical/project management, clinical/regulatory, clinical/commercial, etc.).
  • Demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global team environment.
  • Strong and effective communication skills (written and verbal), with excellent medical/scientific writing skills.
  • Excellent personal ethical integrity and a commitment to improving the outcomes for patients.

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.
 

How to reach us

Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
  • HR Project Manager
  • Frau Cathrin Grolig