Pharvaris Careers

Pharvaris is a Nasdaq listed 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). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely. Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning and you can make a difference – Pharvaris is the place for you!

We are now looking to add capabilities to our regulatory team, considering ongoing and upcoming filings in Europe and the United States, and seeking to therefore hire a Regulatory Affairs CMC writer, to join our Regulatory Affairs team and report to our Senior Director, Regulatory Affairs CMC.

This role will work collaboratively with the Regulatory, R&D and Technical Operations teams on writing projects for early and late-stage development programs. The selected candidate will be tasked with drafting, reviewing and finalizing CMC content and modules for INDs and CTAs, and later, should our clinical trials be successful will also help prepare NDA and MAA related content for the FDA, EMA and other regulatory bodies as needed.

Location

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

Responsibilities

• Author CMC sections for filing and maintenance of INDs, CTAs, IMPDs, NDAs and MAA submissions as well as CMC source documentation for our clinical programs
• Collaborate with Regulatory colleagues to execute CMC submissions and authoring strategy for assigned projects
• Proactively plan and manage writing activities across assigned projects as needed, ensuring adherence to the technical writing strategy and alignment with regulatory & health authorities’ requirements
• Ensure consistency across all communications including all technical documents
• Act as the technical writing expert for CMC regulatory submission documents in cross-functional project teams
• Adhere to generally accepted writing standards to support CMC documentation
• Create and maintain core documentation dossiers utilizing internal templates and tools
• Participate in cross-functional team projects as needed
• Proactively identify process improvement opportunities which align with business needs, and propose and deploy solutions as needed

Requirements

• Bachelor’s degree in Life Sciences required; advanced degree such as MSc, PharmD or PhD is a plus.
• 5+ years of experience in Regulatory CMC in a pharmaceutical or biotechnology setting
• Possess a strong understanding of quality and technical requirements for the preparation of source documents and regulatory dossier content, with the ability to critically assess such documentation, identify gaps or inconsistencies, and work proactively with technical and quality teams to ensure completeness and regulatory readiness.
• Prior experience with FDA related submissions is required, prior experience with EMA, Japan and China submissions is a plus
• Regulatory CMC writing experience for small molecules and/or rare diseases is a plus
• Demonstrated expertise in developing CMC content in briefing documents, quality amendments, module 2 and 3 updates as well as CMC source documents in support of US and global regulatory submissions
• Excellent IT skills including MS Excel, as well as authoring technologies and document management systems
• Experience with eCTD is a plus, understanding of general electronic submissions guidelines is a must
• Experience with StartingPoint templates is a plus
• Highly effective communication and collaboration skills (verbal and written in English), excellent analytical skills and attention to detail
• Ability to manage several priorities & work independently while optimally delivering results
• 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

Pharvaris, a public and clinical stage company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, has an opportunity for a highly motivated Clinical Development Lead, to join and help drive clinical development and compliance efforts.

The Clinical Development Lead will provide medical input to clinical development and Global Program Teams (GPTs), serve as medical expert for the study teams and medical monitor for phase 1-3 clinical trials. This position offers substantial opportunities for scientific interactions and career advancement in the fast-moving area of rare diseases. Reports to Head of Clinical Development, who is based in the United States (East Coast)

Location

This role is preferably based in the Unites States (MA). Pharvaris supports its staff to be home based and work virtually.

Main Activities

• Developing and setting long and short-term objectives according to defined global clinical strategies and discussing them with clinical staff.
• Strategic guidance to phase 1-3 development programs and oversight of global clinical trials/trial teams on assigned programs.
• Capable to lead study protocol development, oversee study execution and final study report development
• Capable to address safety issues reported in responsible program and development mitigation plan
• Participation in Clinical Team and Operations meetings, explaining and discussing the necessary program expenses and budgets. Medical Expert for clinical study teams.
• Assessing new medical information and data on therapeutic areas and designing related clinical strategies to steer the development of products.
• Presentation at academic congresses, investigator meetings and advisory meetings.
• In preparation for submission, scientifically writing and reviewing clinical parts of submission dossiers from a medical perspective to ensure agreement with global strategies.
• Due diligence: assessing and evaluating clinical strategies and/ or policies of external parties.
• Participating in external professional bodies to identify potential spokesperson and create key opinion leaders for the relatively unknown areas of assigned therapeutic areas.
• Keeping up to date with scientific development within the therapeutic areas and providing appropriate training to staff.

Essential Requirements, Experience and Competencies

• MD, preferably with a relevant specialization (eg:,immunology, gastroenterology, hematology nephrology).
• 5+ years of industry experience of clinical development, especially in rare diseases.
• Regulatory experience, especially with successful IND, NDA submission experience preferred.
• Excellent written / oral communication skills. English is company language.
• Attention to detail and ability to think strategically.
• Willingness to take on new responsibilities.
• Interest and ability to learn about new therapeutic areas.
• Able to manage multiple projects and collaborate across various functional groups.
• Ability to thrive in a dynamic environment with high level of agility; a wide degree of creativity and strategic thinking is expected.
• 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.
• Willingness to travel to conferences, scientific advisory meetings, trial sites, investigator meetings: approximately 25%.

Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. By targeting this clinically proven therapeutic target with novel, oral small molecules, the Pharvaris team is advancing new alternatives to injected therapies for the prevention and treatment of hereditary angioedema (HAE) attacks, and other bradykinin B2-receptor-mediated indications. HAE is a rare and potentially life-threatening genetic disease and people living with HAE can suffer sudden and prolonged attacks of swelling in multiple areas of the body, including the airway, which can be life-threatening.

We are expanding our U.S. Medical Affairs team and are looking for two Medical Science Liaisons (MSLs), to join our team and report to our Head of North America Medical Affairs.

We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely.

Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning, and you can make a difference – Pharvaris is the place for you!

Location

These roles are based in the United States:

• one MSL to cover West Coast – AZ, CA, CO, NV, UT, WA and
• one MSL to cover the Northeast – CT, MA, MD, NJ, NY, OH, PA and neighboring states

Candidates are ideally based near a hub which allows for frequent and easy travel.

The selected candidate will be expected to cover approximately 1/3 of the continental United States and focus on engaging with key opinion leaders (KOLs)/ healthcare professionals (HCPs) at major hospitals and rare disease centers.

We have offices in Switzerland (Zug), the Netherlands (Leiden) and the U.S. (greater Boston area) and, at Pharvaris, we promote and enable a flexible hybrid work-environment and support our talent to be home based and work virtually. Whilst this is a remote role, you must be located in the U.S.

Responsibilities for these roles include:

• Serve as the field-based voice of the Pharvaris Medical Affairs Team and play a pivotal role in building and strengthening our MSL and field presence.
• Systemically and proactively identify the scientific exchange needs of KOLs, investigators and other stakeholders in patient care, as well as thought leaders in academia, regional payers and relevant government organizations per strategic territory plans including management of strategic scientific partnerships.
• Ensure compliant communication and education of Pharvaris’ product portfolio to meet the educational and professional needs of Pharvaris’ key external stakeholders, including the creation and deployment of standard responses in close collaboration with Medical Communications and Publications.
• Partner closely with colleagues in Medical, Clinical Development and Clinical Operations, to design and deploy scientific programs, medical advisory boards and other programs and events as needed.
• Partner closely with colleagues in Commercial to provide scientific exchange and appropriate support to payer organizations.
• Provide support to Investigators currently involved in Pharvaris’ international and observational studies as well as investigator sponsored research.
• Proactively obtain and maintain expertise in relevant disease areas and indications, as well as MSL best practices.
• Build and maintain HCP/KOL plans and ensure customer relationship management system (Veeva) is kept up to date with all relevant feedback provided, in a timely, accurate and compliant manner. This includes, but is not limited to, key medical insights received that should also be proactively communicated to relevant colleagues across the business.
• Participate in cross-functional team projects as needed, such as creating and implementation of standard operating procedures.
• Proactively identify process improvement opportunities which align with business needs, and propose and implement solutions as needed.

Requirements/Key Attributes:

• Advanced scientific degree preferably; M.D., PharmD or Ph.D.
• Master’s degree in life sciences required, or MPH in combination with strong and relevant work experience.
• 5+ years of MSL experience with primary emphasis on rare diseases and field-based scientific exchange.
• Preference for candidates who have worked for emerging biopharmaceutical companies in the past, with evolving operating procedures and employee remits.
• Solid understanding of clinical research.
• Preference for candidates who have developed expertise in rare disease or at least allergy/immunology in an academic or professional setting.
• Demonstrated ability to establish trusted relationships and partnerships through scientific engagement.
• Track record of creating and deploying scientific presentations to individual HCPs and groups of internal and external stakeholders in virtual and in-person settings.
• Readiness to travel to the degree appropriate to support the business, primarily within the assigned territory. Maximum travel time estimated up to 80% on a monthly basis at the time of specific events.

We are looking for someone that embodies:

• Ability to work independently in a field-based setting, including demonstrating ownership and accountability in driving scientific engagement and delivering on the company’s ambition.
• Excellent communication and presentation skills, and ability to exchange scientific ideas and information openly and effectively with KOLs and colleagues.
• Proven ability to build trust based relationships with healthcare providers and external experts.
• Ability to motivate, influence, negotiate, and collaborate with internal and external stakeholders through efficient management of relationships within a cross-functional matrix.
• Strong planning and project management skills, ability to cope under pressure with conflicting priorities, handling ambiguity and changes in a rapidly evolving environment while maintaining an action- and result-oriented “can do” approach.
• High level of integrity and adherence to best practices, guidelines, and policies as applicable to Medical Affairs and to cross-functional teams.

Interested?

• Please send your resume to careers@pharvaris.com. We look forward to speaking to you.

Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. By targeting this clinically proven therapeutic target with novel, oral small molecules, the Pharvaris team is advancing new alternatives to injected therapies for the prevention and treatment of hereditary angioedema (HAE) attacks, and other bradykinin B2-receptor-mediated indications. HAE is a rare and potentially life-threatening genetic disease and people living with HAE can suffer sudden and prolonged attacks of swelling in multiple areas of the body, including the airway, which can be life-threatening.

We are expanding our Technical Operations, Global Supply Chain team and are looking for a Director, U.S. Supply Chain to join our team and report to the Head of Global Supply Chain.

We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely.

Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning, and you can make a difference – Pharvaris is the place for you.

Location

We have offices in Switzerland (Zug), the Netherlands (Leiden) and the U.S. (greater Boston area) and, at Pharvaris, we promote and enable a flexible hybrid work-environment and support our talent to be home based and work virtually. Whilst this is a remote/hybrid role, you must be located in the U.S. (Greater Boston area strongly preferred).

Responsibilities for this role include:

Core responsibilities

• Set up and lead the U.S. Supply Chain operations, including purchasing and logistics in agreement with the Global Supply Chain Head and the other Pharvaris functions. Focus on efficiency, costs optimization and strategic partnership
• Support the selection of the Third Party Logistic (3PL) provider in U.S., lead the negotiation and its implementation. Manage the selected 3PL and coordinate the related warehouse operations along with all related product movements (receipts, stocktaking, waste, shipments, sampling, etc). Lead Quarterly Business review Meetings with the 3PL
• Coordinate the implementation of the Order to Cash process with the 3PL in collaboration with Finance and Market Access
• Ensure GMP, Customs and Trade compliance in the U.S. Supply Chain operations are compliant with relevant regulations and industry standards
• Monitor U.S. Inventories. Participate into the Global S&OP process. Align with Commercial on Sales Forecast and Supply Plan to meet demand. Coordinate handling of Sales Forecast in the ERP system
• Monitor Forecast Accuracy and propose improvements. Provide regular reporting to senior leadership on key performance indicators (KPIs) such as forecast accuracy, supply performance, and inventory turnover
• Design and implement supply chain processes to enable U.S. product launch and ensure seamless post launch Supply Chain operations
• Take responsibility for supply risk management for the U.S. territory (stock levels of finished product, storage locations, disruptions, etc)
• Support implementation of the ERP system for the U.S. supply chain operations: definition of business processes (import, logistics, repackaging, inventory management, order to cash), testing, training. Manage the U.S. supply chain operations in the ERP system

Other responsibilities include:

• Coordinate implementation of the Serialization system for U.S. operations. Develop processes to maintain compliance, communicate and manage exceptions with external stakeholders
• Coordinate repackaging operations with external Packaging CMO in U.S.
• Coordinate development of U.S. packaging labelling artwork in collaboration with Regulatory Affairs, Commercial, external agencies and Packaging CMOs
• Support Early Access Program in U.S. as required
• Provide ad hoc support for other Supply Chain initiatives (i.e. packaging tech transfer, logistics, distribution, validation, launch excellence, GxP compliance, etc)
• Identify areas for improvement within the supply chain, implementing best practices, and driving continuous optimization efforts

Requirements/Key Attributes:

• Bachelor’s degree in business, Supply Chain, Operations or related field; advanced degree preferred
• At least 7+ years of experience in Supply Chain or related roles within the pharmaceutical or medical devices in U.S.
• Proven track record in leading logistics and planning processes in a complex, regulated environment; strong understanding of pharmaceutical supply chains, including manufacturing, distribution, and regulatory consideration; experience in launching new products in several geographies
• High proficiency in English, written and spoken. Additional European languages are a plus

We are looking for someone with:

• Strong leadership and experience in leading cross-functional teams in a matrix environment
• Excellent communication skills in a multi-cultural environment in an international company, both written and verbal, with the ability to engage and influence senior stakeholders and external Service Providers
• Advanced analytical skills, including proficiency in supply plans, inventory optimization and financial analysis
• Ability to navigate ambiguity in a fast-growing company and drive consensus across diverse teams
• 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
• Deep understanding of ERP systems (e.g. Microsoft Dynamics, SAP, Oracle) and their application in a global context. Daily use of analytical IT tools
• Strong project management skills, with the ability to handle multiple priorities and lead complex initiatives
• Knowledge of global pharmaceutical regulations (e.g. GxP, CSV) and market access dynamics is a significant advantage
• Strategic thinker with a strong focus on execution
• Results-driven and customer-focused, with the ability to balance short-term and long-term objectives. Proven ability to drive continuous improvement and achieve results

Interested?

Please send your resume to careers@pharvaris.com. We look forward to speaking to you.