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, we are looking for an experienced:
 

Sen. Director Clinical Development

Your Tasks

  • Provide leadership and coordination with key research functions to one or more drug development programs.
  • Lead development of the Clinical Strategy/Clinical Development Plan and provide medical oversight into protocol development, study conduct and data generation, as well as reporting.
  • Lead and coordinate study activities in the program.
  • Oversee Phase I-III clinical development programs 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.
  • Be a company representative interacting with external scientific leaders and regulatory authorities for assigned program(s).
  • Search and analyze medical literature to write and review abstracts, manuscripts for publications or presentation internally and externally
  • Lead/participate in strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with clinical development program.
  • Participate in investigator meetings and advisory committee meetings .
  • 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/or in-licensing opportunities
  • Work with specific clinical and research partners to facilitate seamless execution of collaborative efforts.

Our Requirements

  • MD-PhD and strong basic/translational science acumen in a relevant field and demonstrated by the respective publication record.
  • US Board certification in medical oncology/hematology or European equivalent.
  • Subspecialty training in a discipline relevant for oncology/hematology therapeutic area. Demonstrated potential or ability to design, initiate, and conduct clinical studies.
  • Proven experience as a study director in academia or industry, experience in phase I/II oncology clinical trials required, phase III experience preferred
  • Experience and solid understanding of drug developing strategy and process.
  • Experience with FDA IND submissions and/or European and/or equivalent
  • Proven ability to analyze and interpret efficacy and safety data relating to oncology.
  • Able to work across different 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.
  • Nice-to-have: Experience in with BLA/NDA filings
 
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. 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.