Careers

Driven by our values, Pharvarians are committed to improving the treatment of HAE.

At Pharvaris, we believe that every employee contributes directly to our growth and success in bringing choice to people living with hereditary angioedema (HAE). If you are an experienced and self-driven professional – passionate about driving value for patients and excited about bringing innovation to people in need of therapeutic advancement – this could be the place for you.

We offer talented professionals a flexible (hybrid) working environment – where you choose from where and – to some extent – when you work. You will be part of a team of dedicated and caring co-workers, have the opportunity to contribute freely and will experience short & informal lines of communications.

If you are interested in any of the below positions and/or want to confirm your interest in being part of our journey, please reach out to us and send your LinkedIn profile or resume at careers@pharvaris.com.

Legacy and Values

Pharvaris to provide novel oral alternatives that improve the standard of care for people living with HAE. Pharvaris is a leader in bradykinin-mediated diseases and our team has a rich history in the rare disease space. Pharvarians are driven by our values:

considering others care-fully

Consider all those impacted by our Mission and what we do

Consider all those impacted by our Mission and what we do


Lead with empathy and consider implications of our actions on others


It’s always "We" not "I"


Create the company around the right people

leading with trust

Trust and respect expertise, experience and decisions made

Trust and respect expertise, experience and decisions made


Be comfortable with vulnerability and committed to being real, authentic and transparent


Know it’s ok to take appropriate risks and sometimes fail, and when necessary to ask for help


Take ownership, responsibility and always take the initiative

ensuring rigor & diversity of thought

Prioritize rigorous, well-informed decision making based on robust critical thinking, pragmatism and productive challenge

Prioritize rigorous, well-informed decision making based on robust critical thinking, pragmatism and productive challenge


Act with professionalism and bring depth of experience and knowledge


Be open-minded and non-judgmental, encouraging and considering diverse perspectives, opinions and ideas

contributing freely

Have the freedom to contribute, knowing we will be listened to, and recognize everyone has a responsibility to speak up contributing

Have the freedom to contribute, knowing we will be listened to, and recognize everyone has a responsibility to speak up


Be free and expected to think differently and creatively


Have the freedom to work in a way which enables us to be our best

Our legacy in the HAE space, our core scientific expertise, and our values drive our passion to provide patients with choice.

How to apply

If you are interested to be part of a dedicated, global team at Pharvaris, please send your LinkedIn profile or resume to our HR department, careers@pharvaris.com

Open Positions

Pharvaris is a late stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area).To support our lead programs aimed at bringing new, oral options to patients living with hereditary angioedema (HAE), we offer an opportunity for a highly motivated  Manager Regulatory Affairs to join and help drive our late-stage development products in the rare disease space.

If you are a detail oriented professional with a service minded attitude – passionate about driving value for Pharvaris staff working on our HAE programs and  able to create harmony across functions to achieve this common goal, this role could be the perfect fit for you!

 

Location

We prefer this role to be based in the United States, preferably greater Boston area. At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

 

How we see the role

As Manager, Regulatory Affairs, you will contribute to global regulatory affairs projects for two late-stage development products in the rare disease space and with the opportunity to also collaborate on some early-stage development programs. You will help plan and prepare complex regulatory submission documents, primarily for US regulatory filings. You will support management in implementing departmental strategies and policies.

 

Main focus areas

  • Track and coordinate Regulatory activities
  • Assist in the development, execution and maintenance of submission content plans, and provide status updates to designated stakeholders as requested
  • Support maintenance and organization of regulatory documentation, regulatory filings, and communications archiving
  • Assist in Regulatory-specific cross-functional program/study team projects to support clinical trials and registration activities as needed
  • Maintain awareness of evolving Regulatory requirements, trends, and developments including regulatory competitive intelligence

 

How your profile could look like

  • Bachelor’s degree, preferably in a scientific field
  • 5+ years’ experience in drug development, 2+ in Regulatory Affairs
  • Knowledge of regulatory drug development
  • Excellent verbal and written communication and presentation skills (English)
  • Strong team player and ability to work across functions (matrix regulatory team)
  • Comfortable in a small company environment that is fast paced, challenging and where all employees must take on a hands-on approach to get results
  • Ability to multi-task and manage workload independently with excellent attention to detail
  • Strong Microsoft Office skills
  • Excited and driven by science and the vision to improve disease management and patient care

 

If you are interested to be part of a great and highly engaged team at Pharvaris, please reach out and send your full resume and application letter to our HR department, careers@pharvaris.com.

 

We are looking forward to meeting you soon!

Pharvaris is a late stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area).To support our lead programs aimed at bringing new, oral options to patients living with hereditary angioedema (HAE), we offer an opportunity for a highly motivated  Manager, Operations (Technical Operations Group) to join and help drive our ERP and Project Management systems.

If you are a detail oriented professional with a service minded attitude – passionate about driving value for Pharvaris staff working on our HAE programs and able to create harmony across functions to achieve this common goal, this role could be the perfect fit for you!

 

Location

Given the interactions of this role, we prefer this position to be based in the Netherlands or in Switzerland, preferably on regular commuting distance of our offices in Leiden (NL) or Zug (CH). At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

 

General description

The Manager Operations is responsible for the global execution of operational activities supporting Technical Operations Group and other functions. The position reports to the Head of Project Management, VP.

 

Main focus areas

  • Drive the procurement process in cooperation with the Subject Matter Experts (SMEs), legal and finance for Drug Substance and Drug Products; Requests for Proposals (RfP), vendor selection process, contracting and PO generation, monitoring, scope change management, in the relevant ERP and contract systems.
  • Build and nurture strong vendor relationships
  • Support management of timely delivery and receipt of goods and services
  • Maintain tracking sheet of global supplier portfolio including oversight and support for contracts like Confidentiality Agreements, Master Service Agreements, Consultancy Agreements, or Commercial Supply Agreements
  • Manage and maintain batch oversight in terms of value, amount and location
  • Manage periodical batch reconciliation
  • Set up insurance policies for technical operations
  • Act as contact (or support) for warehouses, insurance brokers etc,
  • Support the budgeting process
  • Enhance organization value and efficiency of CDMOs eg by setting up Key Performance Indicators (KPIs)
  • Manage shipment requests and associated processes and documentation, in liaison with relevant parties like SMEs, Project Managers, shipment vendors, finance and accounting.
  • Support audits (financial, QA, regulatory)
  • Assist Technical Operations Group in drafting Standard Operation Procedures (SOP)
  • Assist Technical Operations Group in transactions within quality documentation systems

 

How your profile could look like:

  • Bachelor in supply chain management, logistics or related discipline, alternatively, candidates with a bachelor in chemistry, other life science or comparable qualification, and previous operational exposure to supply chain and/or procurement tasks.
  • 5+ years of experience in the pharmaceutical industry either in R&D, manufacturing, supply chain environment, or direct procurement.
  • Knowledge of the overall pharmaceutical development process over the products life-cycle, from phase 1 to launch and beyond, is an advantage.
  • Excellent communication skills to excel in cross-functional teams
  • Excellent organizational skills, process oriented and attention to detail
  • Autonomous, service oriented and a pro-active, problem-solving (hands-on) attitude
  • Able to work in a fast paced and dynamic environment while effectively managing multiple tasks
  • Excellent English required (oral and written)
  • Professional usage of software tools like e.g. MS office specifically excel, and ERP systems
  • Willingness to learn new tools and procedures
  • Know-how of the global custom manufacturing market for Active Pharmaceutical Ingredients (API) and/or Drug Products is a plus.

If you are interested to be part of a great and highly engaged team at Pharvaris, please reach out and send your full resume and application letter to our HR department, careers@pharvaris.com.

We are looking forward to meeting you soon!

Pharvaris is a public and clinical stage company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases. To support our program aimed at bringing new, oral options to patients suffering from hereditary angioedema (HAE), we offer an opportunity for a highly motivated Head Global Supply Chain to join and help building a global supply chain to bring more choice to people living with HAE and bradykinin mediated diseases.

 

Location

This role is based in Europe, this may be the Netherlands or Switzerland. At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

 

How we see the role and its impact

The Head Global Supply Chain will have accountability for designing, building, implementing, and leading a sustainable global supply chain organization adapted to the needs of Pharvaris. The immediate goal will be to support the launch of lead products currently in late clinical stages in key global markets with a primary emphasis on the US. The Head Global Supply Chain reports to the Chief Technical Operations Officer of Pharvaris.

 

Main activities

  • Design and lead the build-out of the global supply chain operations to support late-stage development and our first commercial launches, considering demand and supply planning, procurement, logistics and distribution, and master data management
  • Develop and implement the supply strategy for key global markets aligned with the go-to-market strategy by the Community Engagement & Commercial team
  • Support the country specific set-up of the supply chain in close collaboration with commercial, legal, and finance, line with the valid regulatory milestones determining launch timing
  • Facilitates Global Supply Chain in the Sales & Operations Planning with the Community Engagement & Commercial and Finance team
  • Implement an efficient and validated IT/ERP system for forecasting, analysis, planning, inventory/batch tracking, in close collaboration with internal partners (IT, finance, QA)
  • Set up an efficient local and international logistics support for drug substance, samples, drug product, and finished product in development, and assist in tailoring an insurance solution for transportation, logistics, warehousing, and distribution.
  • Own and manage supply chain master data and implement a master data management in close collaboration with internal partners
  • Define and manage region/country specific commercial distribution channels along the entire commercial supply chain and identify and select third parties for the efficient warehousing and distribution, with a focus on the US, including trade compliance, transport validation, and serialization
  • Support the selection of the appropriate commercial business model (tolling vs contract manufacturing) in close collaboration with internal stakeholders
  • Negotiate commercial supply agreements and organize Business Review Meetings with commercial suppliers in close collaboration with CMC
  • Manage the future commercial direct procurement and batch oversight
  • Assist in design and management of packaging, labelling for commercial products, and in complying with global serialization requirements for commercial products
  • Hire, train and develop team members balancing internal and external expertise
  • Ensure compliance of global supply chain with regulatory, fiscal, legal, trade, and safety requirements
  • Ensure Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in all steps in handling, storage, and distribution of materials incoming and outgoing
  • Ensure commercial supplies are On-Time-In-Full (OTIF) and perform regular supply risk assessment using state-of-the-art methods and tools
  • Responsible for budget management and meeting overall cost savings and performance targets

 

Your profile

  • Master’s degree in supply chain, engineering, business administration, or comparable education
  • 15+ years of experience in the global end-to-end supply chain in pharmaceutical industry, encompassing global Sales & Operations Planning (S&OP), demand and supply planning, procurement, logistics and distribution, trade compliance, transport validation, and serialization, and master data management
  • Deep understanding of global supply chain models from a design as well as an operating perspective including alternative supply chain models, relationships with potential partners, with a critical requirement for US experience
  • Has previously demonstrated the ability to develop strategies and build from scratch and implement high quality supply chain processes and teams, ideally in smaller organizations
  • Strong experience in managing external partners, Contract Manufacturing Organizations (CMOs)
  • Experience in packaging, artwork, labelling and serialization including state-of-the-art software is preferred
  • Demonstrated experience in setting up ERP for procurement, batch tracking/inventory management
  • Strong understanding of GMP and GDP
  • Experienced in the regulatory framework pertinent to product launches and tech transfers
  • Profound skills Cost-of-Goods optimization, project and budget management, and full understanding of financial analysis.
  • Pragmatic, excellent organizational skills, attentive to details, and process and solution oriented
  • Proven leadership skills and self-propelling but connected
  • Ability to work collaboratively with high transparency, trust, and respect
  • Excellent negotiation and influencing skills
  • Agile in switching from strategy via tactics to operations and back and ability and willingness to operate based on limited information, uncertainty and high level assumptions hence must have ability to think in scenarios and options
  • Comfortable and excelling in a small company environment that is fast-paced, challenging, and where all leaders take on a hands-on approach to get results

Pharvaris is a late stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area).

To support our lead programs aimed at bringing new, oral options to people living with hereditary angioedema (HAE), we have an opportunity for a highly driven HR & Culture Lead to join and help operationalize our HR strategy and priorities.

If you are an innovative & critical thinking HR professional – inspired by building people centric solutions and passionate about balancing pragmatism with high quality, this could be the role for you!

At Pharvaris, our vision for the HR function is to be the trusted partner for leaders and employees looking to build an exceptional workplace. Our HR strategy and priorities revolve around 4 pillars:

  1. Solidifying talent attraction & retention
  2. Improving the people (employee) experience
  3. Shaping the Pharvaris culture, and
  4. Continuing our journey to achieve best in class HR operations & compliance

We understand that our Company thrives when our employees thrive, and it begins with hiring the right HR & Culture Lead to come and join our team.

As a HR & Culture Lead, you will get involved in all aspects of the employee life cycle – from sourcing potential talents to managing their growth journey in the organization. Your main objective will be to contribute to creating and implementing people solutions that help Pharvaris meet its ambitions and goals.

You will have both strategic and hands-on responsibilities and will support across the team and the organization with important functions such as staffing, learning & development, and compensation & benefits.

Location

This role is preferably based in Europe, this may be Switzerland or the Netherlands. At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

Responsibilities

  • In alignment and collaboration with the VP Talent & HR Ops,
    • contribute to developing and executing on effective recruitment strategies to ensure timely and qualitative hiring of Pharvaris talents.
    • organize and coordinate recruiting processes (create job descriptions, manage on-line postings, schedule interviews, screen talents, extend offers, prepare new hire paperwork)
    • organize and implement the onboarding & orientation process for new hires (conduct onboarding/orientation sessions, present and explain benefit offerings, and provide employees with a welcoming and inclusive experience
  • Propose, develop and implement initiatives to improve HR (process & program) transparency for all leaders, managers and employees – e.g. guidance on HR programs or processes, development of employee guidelines, …
  • Provide employee relations support for employees and managers, including making recommendations on resolving issues
  • Provide guidance, tools and training for managers and employees on select HR programs and processes (e.g. Year End Compensation review, Performance Management, …)
  • Partner with select business leaders and provide sound and pragmatic advice on
    • organizational structures/design,
    • identification of key talents, identification (budgeted) hiring needs,
    • people practices, etc.
  • Monitor employee morale and company culture, and support the creation of employee engagement initiatives
  • Drive and execute on diverse HR projects and initiatives, as e.g. Engagement surveys, Learning platforms, Workshops, …

 

Skills & Qualifications

  • At least 5 years’ experience in a HR position required, experience in a biotech or pharma environment a plus
  • Advanced knowledge of HRIS and ability to learn new technical systems, when necessary
  • Deep knowledge of and experience with MS Office tools, including advanced excel and PowerPoint skills
  • Thorough knowledge of HR procedures and policies, basic understanding of payroll, social security and benefits situation in the geographies Pharvaris operates in can be a plus
  • Excellent listening, verbal, and written communication skills with employees and all levels of management
  • Able to create a working environment of open communication and trust, and high level of empathy
  • Strong ethics and cultural awareness
  • Highly detail-oriented with excellent organizational skills and multi-tasking abilities, sound dose of resilience
  • Aptitude for problem-solving & resourceful thinking, ‘can do’-mentality.
  • Ability to confidentially manage HR related information and demonstrate ethical and professional conduct at all times
  • Logical and analytical skills

 

If the above captured your interest, and you would want to learn more about this opportunity, please do not hesitate to reach out. Looking forward to meeting (and working with) you soon.

Pharvaris, a clinical stage, public company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, is seeking a highly motivated and experienced Global Program Leader to join and help drive our development efforts.

Location

This role is based in Europe (either in Zug, Switzerland or Leiden, the Netherlands). Pharvaris supports its staff to be home based and work virtually. The Global Program Management reports to Chief Technology Operations Officer of Pharvaris.

General description

The Global Program Leader leads the cross-functional Global Program Team and applies in-depth knowledge and experience in pharmaceutical development and commercialization, coupled with expertise in program cross-functional integration, to ensure execution of strategic objectives of Pharvaris.  The immediate goal will be to guide the lead product from its late clinical stages to approval in key global markets.

 

Responsibilities

  • Lead cross-functional Global Program Team to shape product strategy and integrated development plans, including all aspects of program planning and execution such as timeline and milestones tracking, decision making support, budget oversight, portfolio management activities and internal reporting.
  • Set program goals aligned with executive management and drive cross-functional strategic alignment.
  • Efficiently and collaboratively drive and track execution of program strategy against plan with rigour and reach decision making.
  • Ensure that project deliverables are clearly defined and aligned across the organization, and maintain budget and timeline accountability.
  • Facilitate open communication by building working relationships across the organization and fostering an atmosphere of respect and trust to make sure all issues and questions are being addressed and all speak out openly.
  • Stimulate creative and productive decision making, motivate, determine accountability and urgency, identify opportunities, challenges and resource bottlenecks, and drive robust and informed discussions on risk identification and mitigation or contingency plans.
  • Actively supports business case and scenario development.
  • Update the target product profile (TPP) in collaboration with commercial, market access, clinical, and regulatory affairs.
  • Communicate program strategy, risks and issues to senior management.
  • Represent Global Program Management internally and externally.

 

Qualifications

  • Master’s degree in life sciences with experience in the drug development process required, advanced degree and/or certification in Project Management preferred.
  • Demonstrated track record of success in industry with 10+ years of overall industry experience with increasingly complex pharmaceutical projects in a multi-disciplinary, global environment including strategy development and execution required, experience in smaller pharma companies preferred.
  • Experience in all phases of clinical drug development required, with pertinent experience in late stage, launch and commercialization.
  • Proven track record of matrix team leadership in a global environment.
  • Demonstrated development spirit and experience in rare diseases, preferably in bradykinin 2 mediated conditions and HAE, with demonstrated understanding of the role of basic biology and early development, clinical pharmacology.
  • Strong understanding of commercial inputs, CMC, and regulatory filing with health authorities.
  • Excellent verbal and written communication and highly evolved influence, negotiation, and conflict resolution skills, including the ability to influence without clear reporting authority. Ability to identify and manage stakeholders, including at the most senior levels in the organization.
  • Strategic thinking and business acumen with the ability to make recommendations to effectively resolve problems or issues, by using sound judgment that is consistent with business standards, practices, policies, procedures, and regulations.
  • Knowledgeable in budget and finance processes appropriate to the pharmaceutical industry.
  • Demonstrated ability to present complex programs to senior leaders and influence decision making.
  • Prior success with managing cross-functional development teams in a hands-on, highly collaborative, fast paced growth environment.
  • Demonstrated ability to objectively assess sparse data sets, make informed decisions and take action in the face of uncertainty.
  • Personal credibility, outstanding leadership skills, applying highest ethical standards and nurturing an atmosphere of trust and respect.

Pharvaris, a clinical stage, public company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, is seeking a highly motivated and experienced Head of CMC to join and help drive our development efforts.

Location

This role is based in in Europe (either in Zug, Switzerland or Leiden, the Netherlands). Pharvaris supports its staff to be home based and work virtually. The Head of CMC reports to the Chief Technology Operations Officer of Pharvaris.

General description

The Head of CMC leads the cross-functional CMC team and applies in-depth knowledge and experience in end-to-end pharmaceutical development and manufacturing to streamline and strengthen CMC with an immediate goal to guide the lead product from its late clinical stages to approval in key global markets. The responsibilities cover strategic, organizational, scientific, technical, budgetary, and contractual (legal) aspects of CMC ranging from preclinical development to the manufacturing of drug substance and drug product for clinical and future global commercial supplies.

 

Job Description

  • Establish and lead all technical development and commercial manufacturing activities by developing and executing the overall CMC strategy considering all cross functional aspects to meet corporate goals.
  • Lead, develop and coach a team of CMC experts comprising all relevant CMC functions.
  • Ensure On-Time-In-Full (OTIF) supplies for clinical stages, launch and commercial re-supply, based on input from Global Program Management and Global Supply Chain, managing a global network of Contract Development and Manufacturing Organizations (CDMO).
  • Accountable for the end-to-end planning (Drug Substance to IMP or Finished Product) for both development and commercial supply, and constructively challenge other CMC functions, aligned with Global Program plan.
  • Take a flexible hands-on approach in supporting CMC functions if required.
  • Ensure Drug Substance and Drug Product development be state-of-the-art, stage-adapted, securing data-based definition and update of the QTPP.
  • Lead cross-functional team to select appropriate QbD strategies, process parameter risk assessments, application of prior knowledge, and justifying process parameter ranges to maximize operational flexibility during commercial manufacturing. Lead the QRM process in close collaboration with QA.
  • Ensure regulatory packages support and provide technical support during PAI related to relevant dossier sections.
  • Oversee supplier relationship management with team. From identification of outsourcing partner to selecting the CDMO, with an emphasis on negotiation of Master Service Agreements, supplier relationship management, performance monitoring against pre-defined Key Performance Indicators, and performing on-site technical audits.
  • Supply risk management for all CMC development and commercial activities: assess and mitigate supply risks with the functional experts within the CMC team and Global Supply Chain for commercial projects.
  • Negotiate commercial supply agreements supported by internal partners and manage all technical aspects of commercial projects, lead the collaboration with Global Supply Chain.
  • Monitor cost and resource needs and negotiate budget with management.
  • Proactive communication and reporting of issues, status and planning of CMC activities in cross functional Global Program Team as well as to the appropriate management level.

 

Key requirements and qualifications

  • Chemist, Chemical Engineer, or Pharmacist with PhD and minimum of 15 years of relevant experience in the pharmaceutical or chemical industry including R&D, manufacturing, technical project and supplier management in a GMP regulated environment.
  • Minimum of 7 years of hands-on experience in process development, scale-up and tech transfer in pharmaceutical industry.
  • Senior level CMC-project management experience leading interdisciplinary teams on complex projects for at least 5 years.
  • Expert knowledge and scientific expertise in all phases of the global technical development of an innovative new drug substance and/or drug product, ranging from early clinical studies until launch, commercialization, and technical life cycle activities. Experience in both drug substance and drug product development is preferred.
  • Thorough understanding of Quality Risk Management, project risk management and Quality by Design.
  • Strong knowledge in regulatory requirements and strategies for drug development in EU, US, APAC with focus on EMA and FDA.
  • Experience with patent applications and IP strategies to secure freedom to operate.
  • Experience in establishing and managing effective relationships with CDMOs and other external partners, deep understanding of the global CDMO market.
  • Experience in contract law and understanding of core business functions like finance and accounting.
  • Proactive with regards to timelines and quality, rigor in delivering On-Time-In-Full.
  • Sound understanding of business and commercial requirements with special emphasis on supply chain security.
  • Highly evolved communication, negotiation, and organization skills.
  • Proven track record in leading scientific experts and managing, developing, and coaching team members from diverse technical and educational backgrounds.
  • Grounded and stable personality with an open and positive demeanor.
  • Fluent in English.
  • Excited and driven by science and the vision to improve disease management and patient care.
  • Comfortable and excelling in a small company environment that is fast paced, challenging and where all leaders take on a hands-on approach to get results.

Pharvaris is a public and clinical stage company developing bradykinin B2 receptor antagonists for the treatment of bradykinin-mediated diseases. To support our programs aimed at bringing new, oral options to patients suffering from hereditary angioedema (HAE), we offer an opportunity for a highly motivated QA GMP Lead to join and help drive our programs to bring more choice to people living with HAE and bradykinin mediated diseases.

If you are an innovative & critical thinking professional – passionate about driving value for patients and able to create harmony across functions to achieve a common goal, this could be the role for you!

 

Location

This role is based in Europe, this may be the Netherlands or Switzerland. At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

 

How we see the role and its impact

The QA GMP Lead will join the Pharvaris QA group and will be part of the team to support and guide our CMC team in all quality-related topics regarding drug substance, drug product and packaging activities.  This role will oversee and manage documentation and procedures related to production, quality control and batch certification of investigational medicinal products. The function will work closely with and report to the Director GMP.

 

Main Activities

  • Responsible for QA oversight of Pharvaris’ CMC supplier network.
  • Negotiate and manage quality technical agreements for cGMP manufacturing projects.
  • Review and approval of protocols, instructions, specifications, and records, in particular batch records, stability and validation protocols and reports.
  • Lead and oversight of suppliers’ qualification and validation activities.
  • Review, approval and tracking of change control activities considering regulatory notification and approval, when required (internal and external).
  • Drive the internal system for quality records regarding non-conformity issues (e.g., deviations, OOS, complaints) and corrective and preventive actions. Review and approval of such records from external partners.
  • Support maintenance and continuous improvement of Pharvaris Pharmaceutical Quality Management System, including Quality Risk Management.
  • Perform self-inspections and support of regulatory and pre-commercial (readiness) inspections.
  • Lead and/or support qualification of suppliers and service providers as part of Pharvaris vendor/supplier qualification program.

 

What your profile could look like…:

  • Pharmacist, chemist or equivalent.
  • 10+ years in pharmaceutical industry; thereof at least 3 years in quality assurance in similar roles.
  • Broad experience in QA-aspects of drug substance (small molecule) and/or drug product (solid dosage forms) development activities. Good understanding of the overall pharmaceutical development process over the entire product life cycle.
  • In-depth understanding of quality systems, cGMP, regulations, and guidelines relating to CMC.
  • Experience in investigational medicinal product packaging and release activities (batch/sponsor release).
  • Trained GMP (lead) auditor, Qualified Person (QP)/Responsible Person (RP in CH) qualification, FDA expertise and sterile dosage form experience are considered a plus.
  • Excellent verbal and written communication and presentation skills (English).
  • Good team skills: comfortable in an interdisciplinary and international environment; able to communicate and to collaborate effectively in a team.
  • Comfortable in a small company environment that is fast paced, challenging and where all senior staff must take on a hands-on approach to get results, ready to drive decision making within area of expertise.
  • Ability to multi-task and manage workload independently.
  • Willingness to promote a quality mindset actively and persistently within the company by openly communicating and acting as a leading example.

 

Interested?

This position is within the highly collaborative and dynamic QA department that strives to achieve compliance through support and guidance. This role is based in Europe and reports to the Director GMP.

If you are interested to be part of a great and highly engaged team at Pharvaris, please reach out and send your full resume and application letter to our HR department, careers@pharvaris.com.

We are looking forward to meeting you soon!

Pharvaris is a public and clinical stage company developing bradykinin B2 receptor antagonists for the treatment of bradykinin-mediated diseases. To support our platform of novel, potent and selective B2-receptor antagonist small molecules, we offer an opportunity for a highly motivated Senior ADME professional to join and help drive our research to help people living with bradykinin-mediated diseases.

If you are an innovative & critical thinking professional – passionate about driving value for patients and able to create harmony across functions to achieve a common goal, this could be the role for you!

 

Location

This role is based in Europe, this may be the Netherlands or Switzerland. At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

 

How we see the role and its impact

The Senior Lead ADME will join the Pharvaris Early Development group and will be part of the ADME team to support drug development.  This function will be responsible for driving outsourced nonclinical ADME studies at the stages of lead optimization up to clinical development.  The individual will apply their deep knowledge and expertise in absorption, distribution, metabolism, and excretion studies to the development of Pharvaris’ small molecules.  This role will design, oversee, manage, and interpret nonclinical in vitro and in vivo ADME studies; communicate the outcomes, manage timelines and ensure proper reporting.  The function will work closely with and report to the Head of ADME.

 

Main Activities

  • Contribute to the progress of preclinical lead candidates, and the characterization of clinical stage compounds through appropriate nonclinical ADME/PK studies in compliance with industry regulations and standards.
  • Support the strategy and outsourcing of ADME/PK studies to external vendors/CROs.
  • Establish, coordinate, optimize and review study plans in accordance with the ADME strategy.
  • Produce high-quality analysis, interpretation and integration of nonclinical ADME/PK data generated with external vendors/CROs; present these to the team in a clear and transparent fashion, including a way forward.
  • Take responsibility for review and finalization of study reports together with the CROs, team and direct management.
  • Contribute to ADME/PK sections in key preclinical and regulatory documents including investigator brochures, IND/IMPDs, CTAs and NDAs within agreed timelines.
  • Proactively interact and communicate with key stakeholders: medicinal chemistry/CMC, pharmacology, toxicology, clinical pharmacology, clinical team, and regulatory affairs.
  • Take ownership of study plans, data analysis, interpretation, communication, and data reports produced within the ADME team.
  • Effectively communicate updates and progress to management.

 

What your profile could look like…:

  • PhD degree and postdoctoral training in life sciences.
  • Typically, at least 7 years of industry experience in the science and state-of-the-art studies for evaluation of absorption, distribution, metabolism, and excretion.
  • Small molecule drug development experience. In-depth knowledge in bioanalysis is a plus.
  • Contributed to successful transitions of drug candidates into clinical development.
  • Understanding of regulatory requirements in drug development.
  • Experience in selecting, establishing, and managing effective relationships with CRO and other external partners.
  • Proactive with regards to timelines: insight and understanding of studies to be performed, and reports to be finalized.
  • High standard of integrity, ability to think strategically.
  • Excellent verbal and written communication and presentation skills (English).
  • Good team skills: comfortable in an interdisciplinary and international environment; able to communicate and to collaborate effectively in a team.
  • Comfortable in a small company environment that is fast paced, challenging and where all senior staff must take on a hands-on approach to get results.
  • Excited and driven by science and the vision to improve disease management and patient care.
  • Ability to multi-task and manage workload independently.
  • Ability to follow a highly professional and in-depth scientific approach.
  • Sense for detail and accuracy.

 

Interested?

This research position is within the highly collaborative and dynamic Early Development department that strives to achieve high quality data through rigorous research. This role is based in Europe and reports to the head of ADME.

If you are interested to be part of a great and highly engaged team at Pharvaris, please reach out and send your full (scientific) resume and application letter to our HR department, careers@pharvaris.com.

 

We are looking forward to meeting you soon!