careers

Pharvaris, a public and clinical stage company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, has an opportunity for a highly motivated (Associate) Director ADME to join and help drive nonclinical discovery and development efforts.

Location

This role is based in Europe, preferably Leiden, NL.  Pharvaris supports its staff to be home based and work virtually.

Role

Pharvaris is seeking a motivated and energetic individual with a relevant scientific background to be part of the nonclinical team.  The ideal candidate will support the ADME profiling of drug candidates from the candidate selection stage, through preclinical development and clinical development, up to final submission.

 

Role and Responsibilities

• Provide scientific and technical expertise to drive the investigation of the ADME profile of drug candidates during selection and development phase
• Act as primary contact/study monitor with CRO’s selected for preclinical in vivo and in vitro ADME studies (to discuss budgets, timelines, study plans, results and reports)
• Contribute to the selection of best drug candidates to take forward into development
• Contribute to the preparation of scientific and technical dossiers for regulatory purposes
• Realize compliance according to GLP requirements when required
• Report to project teams and senior management

Profile

• Master or PhD in (Medical) Biology, Pharmacy or Biopharmaceutical Sciences
• At least 5 years’ experience in running/monitoring several types of ADME studies with small molecules at either a relevant CRO or in the pharmaceutical industry
• Candidates with extensive experience in Metabolism, Drug-Drug Interactions and/or Modeling & Simulation will be preferred
• Experience with working in cross-functional teams within a matrix organization
• Experience with writing regulatory documents such as IBs, INDs, NDAs, MAAs
• Experience in establishing and managing effective relationships with CRO and other external partners.
• Excellent verbal and written communication and presentation skills (English).
• Demonstrated record of team skills: comfortable in an interdisciplinary and international environment and able to communicate effectively and to collaborate in a team.
• Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results.
• Rigorous, quantitative, and outstanding attention to detail.
• Ability to multi-task and manage workload independently.
• Excited and driven by science and the vision to improve disease management and patient care.

 

 

How to apply

This research position is within a highly collaborative and dynamic department that strives to achieve high quality and in-depth research. This role is based in Europe, preferably Leiden, NL, and reports to the Senior Director Translational Science & ADME. We offer talented scientists a great working environment, dedicated and driven co-workers, short lines of communications and an attractive compensation package.

Interested?

If you are interested to be part of a great and dedicated team at Pharvaris, please send your full (scientific) resume and application letter to our HR department, .

Pharvaris, a public and clinical stage company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, has an opportunity for a highly motivated GMP Lead/QP to join its team and help drive bringing alternative solutions to patients

Location

This role is based in Europe and can be located in either Leiden, NL or Zug, CH.  Pharvaris supports a work-from-home environment.

Role

Pharvaris is seeking a motivated and energetic individual with a relevant scientific background to be part of the Quality team.  The ideal candidate will have solid experience with GMP in small innovative pharma or biotech and has hands-on experience and aptitude in GMP auditing.

Key Characteristics of the job (Objectives and Responsibilities)

• Maintenance and continuous improvement of an adequate Pharmaceutical Quality Management System as described in ICH Guideline Q10, in particular, generation and updating of a Quality Manual, Quality Policies and Quality-related SOPs
• Performing self-inspections and support of regulatory inspections at Pharvaris
• Review and approval (sign off on behalf of Pharvaris) of all outsourced procedures related to production, Quality Control (QC) and Batch Certification of investigational Medicinal Products (IMPs)
• Review and, if applicable, approval (sign off on behalf of Pharvaris) of (draft) protocols, instructions, specifications, and records, in particular (Master) Batch Records and validation protocols and reports
• Qualification of suppliers and service providers
• Organisation of Audits /Auditing of Contract Manufacturers (CMOs, API manufacturers) Audits can be conducted remotely or face to face (F2F); F2F can be subcontracted if needed
• Involvement in Quality Risk Management (QRM)
• Review of CMO’s Qualification and Validation activities
• Review of proposed changes (Change Control) and their approval prior to implementation considering regulatory notification and approval, where required; Initiation of Changes requested by Pharvaris
• Handling of Non-conformity issues (deviations, OOS, complaints) and corrective and preventive actions (CAPA). 

Job Holder Requirements/Key competencies:

• Education: Pharmacist or Chemist or equivalent
• Minimal work experience: at least 10 years in pharmaceutical industry; at least 3 years in Quality Assurance; trained GMP lead auditor
• Language fluency (or knowledge of): English (fluent)
• Personal skills and other competencies, as needed: goal-oriented, completer/finisher, recognition of inter-cultural differences
• Demonstrated record of team skills: comfortable in an interdisciplinary and international environment and able to communicate effectively and to collaborate in a team
• Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results
• Ability to multi-task and manage workload independently

How to apply

This position is within a highly collaborative and dynamic department that strives to achieve lean processes and added value to the business. This role is based in Europe, and reports to our Head of Regulatory Affairs and Quality, based in the Boston area, US. We offer talented staff a great working environment, dedicated and driven co-workers, short lines of communications and an attractive compensation package.

Interested?

If you are interested to be part of a great and dedicated team at Pharvaris, please send your full (scientific) resume and application letter to our HR department, .