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 Global Supply Chain team, overseeing the end-to-end process for the Sales and Operations Planning (S&OP) for Pharvaris, reporting to the Head Global Supply Chain, who is based in Switzerland.

This senior role (we target Senior Director-level) will work collaboratively with the Commercial and Technical Operations teams to drive the alignment between commercial demand and supply operations. The selected candidate will be tasked with Demand Forecasting & Planning, Supply Network and Capacity Planning and Procurement with External Manufacturing CMOs.

Location

This role is preferably based in 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

• Global S&OP Lead. You will be responsible for overseeing the end-to-end process for the Sales and Operations Planning (S&OP) for Pharvaris, reporting to the Head Global Supply Chain.
• Drive the alignment between commercial demand and supply operations, ensuring that the organization meets customer needs while optimizing Working Capital , production and distribution capabilities. Close collaboration with cross-functional teams, including Commercial, CMC, Finance, to deliver accurate forecasts, effective inventory management, and consistent operational execution. Review CAPEX and OPEX impact for different projects based on sales forecast and supply planning scenarios.  Coordinate inventory target settings with Commercial and Finance.
• Demand Forecasting & Planning: Support the creation and continuous refinement of demand forecasts by working closely with sales, marketing, and market access teams. Monitor forecast accuracy. Handling of demand forecast in the supply planning systems.
• Supply Network and Capacity Planning: Collaborate with CMC and supply chain team to align production capacity, resources, and inventory with demand forecasts. Identify potential bottlenecks or risks and proactively implement corrective actions. Highlight risks and opportunities through Scenario Planning.
• Procurement with External Manufacturing CMOs: manage the whole procurement process with the external CMOs including the operational handling in the ERP system
• Labelling Artwork management: Define SKUs with Commercial and Regulatory Affairs, coordinate artwork design with external artwork studios, coordinate internal approval and change control with Regulatory Affairs/QA, manage version control with the packaging CMOs.
• Demand and Supply Planning Engine: Develop, maintain and act as point of contact with the external IT solution provider, manage Master Data, coordinate regular data synchronization with CMOs, 3PL and Commercial.
• Coordinate evaluation of Vendor Business Performance in collaboration with CMC, Quality and Finance. Manage Business Review Meetings with Vendors and CMOs. Define KPIs and highlight risks in Vendors/Supply and initiate risk mitigation activities.
• Data Analysis & Reporting: Utilize advanced analytics to track S&OP performance metrics, identify trends, and provide regular reporting to senior leadership on key performance indicators (KPIs) such as forecast accuracy, supply performance, batch tracking and inventory turnover.
• Serialization: Supervise product packaging serialization with packaging CMOs, establish internal business processes to manage and share information with external partners and Health Authorities.
• Provide ad hoc support in establishing the commercial ERP system for Supply Chain operations.
• Provide ad hoc support for other Supply Chain initiatives (i.e. packaging tech transfer, logistics, distribution, validation, launch excellence, GxP compliance, ….)

Key requirements and qualifications

• Education: Minimum Bachelor’s degree in Business, Supply Chain, Operations, Engineering or related field; Master’s degree preferred.
• Required work experience: At least 10 years of experience in Sales & Operations Planning (S&OP) or related roles within the pharmaceutical or medical devices industry; proven track record in leading global S&OP processes in a complex, regulated environment; strong understanding of pharmaceutical supply chains, including external manufacturing with CDMOs / CMOs, distribution, and regulatory compliance; experience in launching new products in US and other geographies, ideally in a smaller organization with instrumental hands-on experience.
• Language fluency: High proficiency in English, written and spoken. Additional European languages are a plus.

Personal skills and other competencies

• Strong leadership and experience in leading cross-functional teams in a matrix environment.
• Excellent communication skills, both written and verbal, with the ability to engage and influence senior stakeholders.
• Advanced analytical skills, including proficiency in demand forecasting, inventory optimization, and financial analysis.
• Deep understanding of advanced supply planning systems and their application in a global context. Knowledge of the ERP Microsoft Dynamics 365 is a plus
• Strong project management skills, with the ability to handle multiple priorities and lead complex initiatives in a highly dynamic environment.
• Ability to navigate ambiguity and drive consensus across diverse teams.
• Knowledge of global pharmaceutical regulations and market access dynamics is a significant advantage.
• Strategic thinker with a strong focus on execution. 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.
• Results-driven, hands-on, and customer-focused, with the ability to balance short-term and long-term objectives.

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 looking to grow our regulatory team, considering ongoing and upcoming filings in Europe and the rest of the world, and are seeking a Director, Regulatory Affairs EU/International, to join our Regulatory Affairs Team, reporting to our Senior RA Lead EU & UK, Senior Director.

This role will work collaboratively with the Regulatory and R&D teams on projects for late-stage development programs. The selected candidate will be tasked with drafting, reviewing and finalizing content and modules for INDs and IMPDs, prepare NDA and MAA related content for EMA and other international regulatory bodies as needed.

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

At Pharvaris we promote and enable a flexible hybrid work environment, where our employees choose from where (and to some extent when) they prefer to work. Whilst this is a remote/hybrid role, you will preferably be based in Switzerland.

Responsibilities

• Develop the EU and international regulatory strategy for assigned projects aligned with the global regulatory strategy
• Implement the EU and international regulatory strategy through effective project and time management with the aim of delivering rapid approvals with optimal labelling identified by the business, markets, and patients
• Lead cross functional teams and the preparation for EU and international health authority interactions (such as briefing books for scientific advice and/or health authority meetings) and actively participate in health authority meetings
• Support the planning and preparation of the EU and international regulatory dossiers, according to the company’s submission plans
• Lead the preparation of regulatory submissions in accordance with local guidelines, manages the timely finalization of these submissions
• Contribute to response preparation to EU and international health authority questions including label negotiations, ensures complete and consistent response packages in line with the global development strategy to secure approvals
• Serve as primary point of contact for assigned health authorities
• Ensure effective teamwork across Regulatory Affairs and functional areas, enabling rapid and effective submissions, approvals, and product maintenance activities
• Provide regulatory support for clinical trial applications and overall development program

Requirements

• MSc- degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
• 10+ years’ experience in drug development, 8+ years in regulatory
• Experience as direct contact person with major health authorities, e.g. European Medicines Agency
• Experience in developing materials, attending, and supporting team preparation for major health authority interactions
• Detailed knowledge of regulatory drug development including product approval/launch
• Ability to think strategically and critically evaluate risks to regulatory activities in a business-critical and high-profile development program
• A proven track record in leading submissions, interactions with regulatory authorities, approvals and complex programs across the responsibilities of the specific role
• Experience in therapies for rare diseases and small molecules
• Critical thinking on current regulatory science questions and a good understanding of the corresponding scientific and clinical components
• Excellent verbal and written communication and presentation skills (English). Fluency in writing regulatory documents such as IMPDs, INDs, NDAs, MAAs.
• 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 leaders must take a hands-on approach to get results
• Ability to multi-task and manage workload independently
• Excited and driven by science and the vision to improve disease management and patient care

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%.