Careers

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). 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 caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have 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.

To support our primary programs aimed at bringing new, oral options to people living with hereditary angioedema (HAE), we have an opportunity for a highly driven Global Head of Quality to join and take strategic direction of our Quality department as the organization evolves. This newly created position will ensure that we continue to follow FDA and international regulatory requirements for our Small Molecule Drug Substance (DS) and Drug Product (DP) as we continue down clinical pathways towards a potential commercial future.

The Global Head of Quality will be based on the East Coast of the United States (Hybrid/Remote) and will be attached to our operations in the Boston, MA area. They will report to the VP, Regulatory Affairs & Quality. They will work closely with our existing Quality and Technical Operations teams to ensure that Quality is at the heart of everything we do.

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. Given the nature of this role, we would like this position to be based in the US, preferably on the East Coast.

Key Responsibilities: 

• Lead, manage and develop the Quality Assurance team at Pharvaris, including securing professional development of the Quality Assurance group
• Steer the selection and negotiation of agreements with Quality Assurance suppliers and service providers in accordance with Pharvaris QA budget
• Be accountable for preparation and conduct of all inspections by any regulatory authority
• Establish priorities, define Quality Management goals, and ensure alignment with other relevant business goals
• Oversee deployment & operational excellence of an electronic Quality Management System (QMS) to ensure drug development activities are in compliance with international regulatory requirements and to track quality KPIs
• Act as a Deputy and “right hand person” to the VP, Regulatory Affairs & Quality
• Partner with cross-functional teams to ensure quality considerations are integrated into all stages of the product lifecycle from development through to commercialization
• Assure the Quality team is ready to support growth of the business, with a pipeline of needed skillsets and potential successors for managerial and leadership positions for growing late-stage activities including validations, commercial supply set-up, launch readiness, and set-up of the global distribution and logistics
• Oversee all projects and support the team in case of resource constraints, escalation to management, or conflicts.
• Ensure responsiveness to internal and external customer inquiries and requests
• Provide oversight and support, as required, during the review of Quality agreements and other related documents
• Manage Quality Department budget and resources to address strategic needs including hiring decisions, talent management, and mentoring development
• Support the evolution and auditing of phase-appropriate Standard Operating Procedures (SOPs) to ensure they are in accordance with GxP guidelines
• Monitor industry trends and emerging quality issues to proactively identify risks and opportunities for improvement

Requirements:

• Minimum: Bachelor’s in Life Science, Manufacturing or another related field
• Additional education in Business is a plus (ie.: MBA or similar)
• 12+ years of progressive experience in Quality Assurance with a majority of that time in clinical development stage companies
• Demonstrable experience in preparing for, hosting and responding to regulatory inspections (FDA, EMA, PMDA, MHRA, etc.) from the Sponsor side
• Leadership experience: Minimum 8 years of experience running and growing Quality teams, ideally with direct reports based in different locations
• Experience negotiating contracts with CMOs and other external vendors is an advantage
• Strong interpersonal skills – including the ability to present high level strategic content to C-level executives
• Fluent in English
• Ability to travel at least 20% on an annual basis

Personal skills:

• High ethical standards and integrity and courage to speak up and voice dissent or concern.
• Perspective and judgment to assess what is really important and prioritize in a fast-paced environment.
• Composure and credibility when addressing challenge and conflict.
• Emotional intelligence, flexibility and solution orientation.
• Aptitude for problem-solving & resourceful thinking, ‘can do’-mentality.
• 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.
• Strong understanding of the functional operations within commercial, research and development, finance, quality and human resources in the life sciences space.
• Ability to communicate complex concepts in ways that are understood by cross-functional teams.
• Ability to cultivate strong stakeholder relationships and successfully influence senior leadership and peers.

What we offer:

• Competitive Total Rewards including a 401(k) plan with employer contribution, generous paid time off, an annual bonus and an Equity package (Long Term Incentives)
• A fully hybrid/remote work environment
• A small, growing startup environment which offers every employee significant range of responsibility and the ability to contribute to the company’s strategic objectives

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). 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 caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have 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 now offer an opportunity for a highly motivated GCP Oversight and Compliance Lead to join and help drive development and compliance efforts.

The GCP Oversight and Compliance Lead (OCL) will work both independently and collaboratively to continue and foster a culture of Transparency, Accountability and Quality in Pharvaris clinical development programs from Phase 1 to Phase 3 and beyond.

By employing their significant experience in clinical operations, this role will work cross-functionally to assure robust quality oversight of clinical programs and to ensure regulatory compliance. The candidate should have the ability to actively leverage intelligence gleaned from cross-functional interactions and trends to inform improvements in conducting clinical trials while championing the highest standards of compliance.

This position will support the Global Clinical Quality function and represent the company as a key clinical quality liaison with investigative sites, CROs and other clinical vendors. The OCL will support the continuous improvement of Pharvaris clinical quality systems and compliance strategies involving clinical trials and global marketing preparations. The OCL will be expected to routinely interact with internal and external stakeholders to promote collaboration and ensure all systems, processes, and their outcomes are compliant with applicable international standards, regulations and guidelines.

Location

This role is preferably based in the United States (East Coast). At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

Responsibilities

• Work with cross-functional teams to provide day-to-day GCP oversight and guidance
• Implement inspection preparation framework in order to work towards a state of inspection readiness
• Function as the primary GCP contact for at least one (1) Phase III clinical program and provide backup coverage for colleagues who oversee other studies.
  • Provide clinical quality oversight to the Phase I team
• Identify and communicate GCP quality and compliance risks and implement appropriate plans for resolving issues and mitigating risks
  • Bring a global perspective to these activities to address regional idiosyncrasies including in ex-FDA and ex-EMA regions
• Work with the Clinical Operations team to develop and maintain quality oversight of clinical investigative sites
• Engage with clinical investigative sites in a collaborative manner to ensure compliance and inspection readiness
• Provide input on controlled document development by cross-functional partners.
• Represent GCP QA on project teams to facilitate regulatory compliance both internally and externally
• Review clinical study documents and check for consistency and appropriate standards and practices
• Support inspection readiness activities with cross-functional partners to ensure successful inspection outcomes
• Fosters a team culture of engagement, accountability, collaboration, innovation, sense of urgency to serve patient needs and achieving Pharvaris corporate vision.
• Performs other tasks and assignments as needed and specified by corporate and functional management.

Requirements

• Bachelor’s degree or an equivalent level of training and experience
• Minimum 10 years with progressive experience in clinical operations and/or clinical quality assurance
  • Proven experience with clinical development stage companies
  • Proven experience in rare disease indications
• Demonstrable experience with FDA, EMA, MHRA and/or PMDA inspections from the Sponsor side
• Flexible and adaptable thinking, problem solving and communication skills
• Open personality with proven team spirit and excellent time management, communication and collaboration skills in a cross-functional, international environment
• Excellent interpersonal skills with the ability to adapt effectively in a small company environment that is fast paced, challenging and required a hands-on approach
• Demonstrating proactive planning and management skills and solution-oriented approach; quick learner and able to prioritize effectively showing strong negotiation and influencing skills
• Skilled in establishing and managing effective oversight of CRO and other external partners.
• Excellent verbal and written, communication and presentation skills (English).
• Ability to travel to investigative sites and company meetings as needed. Up to 40%
• 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 staff must 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). 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 caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have 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 now offer an opportunity for a highly motivated Head of Access, Trade and Patient Support, North America to join and help prepare for the commercialization of our late-stage development products in the rare disease space.

The successful candidate will join our North American Leadership Team to lead the North America Market Access & Reimbursement, Specialty Trade & Distribution, and Patient Services teams. This individual will design, build, and lead the US and Canada Market Access, Patient Services and Distribution teams that directly support the commercial success of the company. The responsibilities include building the functional capabilities and strategic leadership to ensure broad access for our product portfolio across all channels; effectively manage value, contracts, and pricing; strategic planning & management of product distribution & channel strategy; reimbursement and payer access; our patient services model & function; developing a world class program for (HAE) rare disease; delivering strategic insights for launch planning. This position reports to the GM, Head of Commercial, North America and has a dotted line to our Head of Global Patient Access and Policy.

This position requires an individual with strong strategic capabilities, as well as the desire to operationally implement strategy in a collaborative partnership with internal & external stakeholders. The selected individual must have proven experience & success in leading an effective North American Access team, as well as in prior experience in collaborating with a global Commercial team.

Location

This role is preferably based in The United States (East Coast). At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

Responsibilities

• Leads the Market Access & Reimbursement, Trade/Distribution Patient Support Services functions in the North America commercial organization, with responsibility for co-creation and execution of strategies that facilitate effective market access for the entire product portfolio.
• Assesses needs and formulates a road map for this newly established function including structure, sub-functions, capabilities, and hiring plan.
• In partnership with Global Patient Access, manages market pricing strategies consistent with customer and market indications and the overall portfolio targeting long-term commercial success.
• Manages relationships with national and regional payers, insurance/managed care organizations, specialty pharmacies and integrated delivery networks, to collaborate and ensure access to care.
• Collaborates with internal and external stakeholders to optimize and implement reimbursement, managed care, payer and healthcare policies that ensure attainment of managed markets business objectives.
• Designs and implements a compliant strategy for best-in-class Patient Support Services, Trade/Distribution and Field Access & Reimbursement model to support HAE patients.
• Partners with North America Medical Affairs, Global Patient Access team and Global Evidence Generation members to ensure the creation of a clinical value dossier for incorporating differentiating and compelling product data.
• Partners and contributes to Global Patient Access projects/initiatives as appropriate.
• Leads the strategic and tactical development of US and Canada distribution for the product(s), as well as contracting, implementation, and operational management of Specialty Pharmacies, 3^rd Party Logistics Providers, Pharmacy Benefit Managers and Specialty Distributors. This includes ensuring a high level of collaboration and integration with the Brand Teams, Finance, and Technical Operations teams.
• Collaboration across North America Trade and Distribution and Head of Global Supply Chain & Manufacturing to manage transportation, logistics and regulatory activities for domestic and international movements, drug product and finished goods to ensure alignment on and optimal, compliant execution of channel model and patient experience.
• Develops and manages departmental budgets that effectively achieve desired goals that are balanced with the financial objectives of the broader commercial organization.
• Ensures compliance with corporate policies and procedures, and laws and regulations applicable to geographic region.
• Designs and builds a team of high performing individuals and is responsible for developing talent, mentoring, and coaching people.
• Fosters a team culture of engagement, accountability, collaboration, innovation, sense of urgency to serve patient needs and achieving Pharvaris corporate vision.
• Performs other tasks and assignments as needed and specified by corporate and functional management.

Requirements

• Minimum bachelor’s degree. MBA, PharmD or advanced degree preferred.

• 15+ years of progressive experience within sales, marketing, or managed markets roles in account management, formulary access, reimbursement, trade & distribution, program development, contract negotiations and policy development.
• 10+ years Access & Reimbursement and patient services experience with responsibility across multiple payer type; rare disease experience preferred.
• Proven long-term relationships with 3rd party payers (commercial / government payers), distribution and trade (specialty distributors, and specialty pharmacy), physician networks, and healthcare systems.
• Ability to positively position a new company in the Managed Care sector to achieve top rare disease company image and benefits.
• Ability to present, interact and influence through strategic recommendations
• Previous experience of successfully developing and leading managed care/payer/access/reimbursement initiatives that supported product launches.
• Previous experience with designing and implementing US/North America distribution strategies and Patient Support Services
• Well versed in biotech/payer strategies, engagement, contracting terms across various segments; including commercial, and government payers; experience with rare disease, gene therapy or injectable biologics.
• Proven blend of strategic and operational experience with the ability to see the big picture while having attention to detail.
• History of successful cross-functional collaboration with Medical, Patient Advocacy, Finance, Legal & Commercial to develop and support an evidence-based and stakeholder-relevant value proposition ensuring access to treatment by people who need it.
• Demonstrated successful experience in a fast-paced entrepreneurial environment.
• Track record of successful launch planning as well as preparation and execution of access and reimbursement and cross-functional pre- and peri-launch projects in US/North America.
• Willingness and ability to travel up to 40%
• Fluency in English is a must
• Highly effective communication and collaboration skills (verbal and written), 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 staff must take on a hands-on approach to get result

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in the U.S. (greater Boston are), the Netherlands (Leiden), and Switzerland (Zug). We have a culture built on core values of caring, trust, diversity and freedom and are driven by individuals committed to developing breakthrough therapies that have real impact on people’s lives. Pharvaris’ mission is to pioneer science for patient choice. 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 currently seeking a highly motivated Communications Specialist in developing a wide range of written, verbal, and digital communications assets to support the mission of Pharvaris. Reporting to the Head of External and Internal Communications, this person will support all areas of communications, with an emphasis on steering internal communications, and will have high cross-functional engagement, such as with the human resources, investor relations, commercial, medical, financial, legal/compliance, clinical, and operations departments.

Location

This role is preferably based in the U.S. (East Coast time zone). At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

Responsibilities

• Drive internal communications strategy and promote company values through execution of existing initiatives and identification, development, and implementation of novel programs and projects
• Manage Pharvaris intranet through collaboration with cross-functional counterparts to communicate company-dependent departmental priorities
• Execute digital communication strategy across multiple social platforms
• Leverage analytical tools to provide innovative recommendations for enhancement of systems and processes
• Support production of executive committee and/or board reports identifying key insights and recommend actions
• Develop and maintain relationships with key stakeholders to understand and incorporate perspectives into corporate messaging

Qualifications

• Bachelor’s degree with 3-5 years relevant work experience (writing test may be required)
• Excellent communication, presentation, problem-solving, and interpersonal skills
• Passion for and proficiency with communication tools, content management systems, and social media platforms
• Strong work ethic, positive attitude, leadership, and teamwork abilities
• Fluent in English
• Ability to travel for team meetings in the Greater Boston area (if not locally based) and potentially to international meetings on occasion

Pharvaris is a late-stage, public 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 caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have 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 currently seeking a highly motivated Global Medical Affairs Lead – HAE to join our team and help our Head of Medical Affairs develop and execute our Medical Affairs strategy. This role will have both strategic and hands-on responsibilities, with significant international travel to engage with key opinion leaders around the world.

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

• Develop & execute Medical Affairs strategy in partnership with Head of M.A.
• Establish and maintain trusted partnerships with international, regional and local Key Medical Experts KMEs, Healthcare Providers (HCPs), Investigators, Scientists and collaborate with them, as appropriate, in the implementation of medical projects for external and internal audiences – these activities will require frequent travelling.
• Represent the Medical Affairs Team in cross-functional decision-making forums – including at Executive Committee level – and actively provide Medical Affairs’ perspective, to identify opportunities and risks while ultimately working towards advancing care and management of people with HAE and bradykinin-mediated conditions.
• Actively contribute to collect and assess medical insights on unmet needs in clinical practice through scientific exchanges with international, regional, and local Key Medical Experts (KMEs) and healthcare providers, patient advocacy organizations, and consulting forums (e.g., advisory boards), and translate them into actionable Medical plans as well as share and leverage them within the broader organization to inform cross-functional decision-making and planning.
• Support design and implementation of evidence-generation and medical education projects.
• Drive strategy and plans for medical and scientific activities at international. regional, and local scientific conferences with particular focus on presentation of scientific data from Pharvaris-sponsored studies and implementation of medical education programs. Attend international, regional, and local scientific conferences as required.
• Build and lead a Medical Information system to endure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards.
• Lead medical reviews of grant and sponsorship requests.
• Implement and operationalize Patients’ Access Programs, as appropriate.
• Act as key medical subject expert for the cross-functional organization and actively ensure continuous and up-to-date education, training and advice on data and evidence related to HAE and other bradykinin-mediated conditions in clinical practice.
• Support implementation of Pharvaris-sponsored clinical trials and studies by supporting medical education and scientific exchanges with clinical Investigators and Investigative Site Staff.
• In collaboration with the Head of Medical Affairs, contribute to build and further develop the Medical Affairs Function at global, regional and local level and establish the operating model.
• Ensure alignment of Medical activities with Industry and Pharvaris Compliance and Regulatory standards, policies, and regulations.

Requirements

• M.D. and/or Ph.D.
• 7+ years of experience in Medical Affairs, ideally within rare disease.
• Previous experience at country affiliate AND global / regional level.
• Previous experience with HAE is a significant advantage.
• Track record of successful launch planning in an international setting.
• History of successful collaboration with Patient Advocacy, Commercial, and Market Access Functions to develop and support an evidence-based and stakeholder-relevant value proposition ensuring access to treatment by people who need it.
• Direct management of multimillion functional budget with diligent financial accuracy.
• Knowledge of and strict adherence to applicable Healthcare Compliance and Regulatory standards, guidelines, and policies as applicable to Medical Affairs and to cross-functional teams.
• Fluency in English is a must, other languages are a plus.
• Must be willing to travel internationally at least 30% on a regular basis, with spikes up to 50% during busy periods. Possibility of consistent 50% travel depending on business needs.

Pharvaris is dedicated to pioneering science for patient choice, specifically bradykinin B2 receptor antagonists for hereditary angioedema (HAE) and other bradykinin-mediated diseases. It is a late-stage biotech company with a portfolio of pre-commercial assets aimed 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.

Headquartered in Zug, Switzerland, with hubs in the Greater Boston and Amsterdam areas, we have a culture built on the core values of caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have 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 currently seeking a highly motivated Associate General Counsel, Corporate, to join our growing global Legal and Compliance (LECO) Team.

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. Given the nature of this role, we would like this position to be based in the US, preferably on the East Coast.

Role 

In this newly created role, you will have the opportunity to help build the global LECO Team as Pharvaris scales the organization for Phase 3 development and ultimately commercialization.

Reporting directly to the Chief Legal Officer (CLO), you will lead the corporate legal activities with a primary focus on securities, corporate governance, M&A and equity issues. In addition, in partnership with the CLO, you will support the Board of Directors and Committees, including preparation for and follow-up from Board and Committee meetings; providing counsel on corporate governance matters; and implementing and managing corporate policies.

You will partner closely with our CEO and our teams in Finance, Corporate Development, Investor Relations, Equity Administration and Communications, among others. You will work cross-functionally and internationally with operating units throughout our organization to provide legal support for business initiatives.

Key characteristics of the role (objectives and responsibilities)

• Lead all corporate legal activities, including corporate governance, SEC compliance, capital markets, corporate transactions and commercial contracts.
• Support the Board of Directors and Committees, including preparation for and follow-up from Board and Committee meetings.
• Drive compliance with applicable reporting requirements of the U.S. Securities and Exchange Commission and Nasdaq, including Regulation FD and periodic filings, and keep stakeholders advised on external governance trends, SEC and NASDAQ issues and best practices.
• Manage the company’s insider trading policy, preclearance procedures and other equity-related matters, including 10b5-1 plans.
• Support the Equity Administration function on equity matters and employee education.
• Provide legal oversight for all external communications in collaboration with Investor Relations/Communications.
• Provide legal support for transactions, including working with Corporate Development on deal structure, planning and assisting in due diligence and actively managing deal process and execution.
• Provide legal advice and counsel to broader organization, including drafting and negotiating various agreements typical for life sciences companies.
• Work closely with and manage external corporate counsel.

Job holder requirements/key competencies:

• Law degree from an ABA-accredited law school or equivalent degree earned in a non-US country.
• Licensed to practice law in one or more of the fifty (50) states within the US.
• Expertise relating to the laws, regulations, and standards relevant to public companies.
• At least five (5) years’ experience with a life sciences company and/or with a law firm counseling life science company clients.
• Prior in-house experience preferred.
• Fluency in English (working language).

Personal skills:

• Perspective and judgment to assess what is really important and prioritize in a fast-paced environment.
• Ability to communicate complex concepts in ways that are understood by cross-functional teams.
• Ability to cultivate strong stakeholder relationships and successfully influence senior leadership and peers.
• Aptitude for problem-solving & resourceful thinking, ‘can do’-mentality.
• 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.
• High ethical standards and integrity and courage to speak up and voice dissent or concern.
• Composure and credibility when addressing challenge and conflict.
• Emotional intelligence, flexibility and solution orientation.

Pharvaris is dedicated to pioneering science for patient choice, specifically bradykinin B2 receptor antagonists for hereditary angioedema (HAE) and other bradykinin-mediated diseases. It is a late-stage biotech company with a portfolio of pre-commercial assets aimed 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.

Headquartered in Zug, Switzerland, with hubs in the Greater Boston and Amsterdam areas, we have a culture built on the core values of caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have 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 currently seeking a highly motivated Deputy General Counsel & Chief Compliance Officer to join our growing global Legal and Compliance (LECO) Team.

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. Given the nature of this role, we would like this position to be based in the US, preferably on the East Coast.

Role 

In this newly created role, you will have the opportunity to help build the global LECO Team as Pharvaris scales the organization for Phase 3 development and ultimately commercialization. Reporting directly to the Chief Legal Officer (CLO), you will lead the implementation of a business-enabling compliance program aligned with our core values and you will partner with the CLO to navigate the full-range of legal matters affecting the company including corporate and commercial transactions, litigation, regulatory, employment, among other areas.

You will partner closely with our teams in commercial, medical affairs, regulatory, quality, patient advocacy, human resources and finance, among others. You will work cross-functionally and internationally with operating units throughout our organization to lead and support legal and compliance initiatives, and to raise the level of awareness of compliance and legal risk management within our organization.

Key Characteristics of the Role

• Closely partner with the CLO to drive the LECO strategy and build and scale a “fit for purpose” function as the Pharvaris organization grows and the company advances the development of its pipeline.
• Provide broad-based legal advice and support to the business in corporate and commercial transactions, litigation, regulatory, employment, among other areas.
• Build out Pharvaris’ compliance program in accordance with developing industry guidance and trends and ensure the compliance program is effectively integrated into the culture and business operations.
• Continue to reinforce a culture of integrity and raise awareness of compliance as a collective responsibility of all company personnel through effective engagement, training, auditing, and monitoring.
• Provide strategic advice to the business to ensure compliance with applicable U.S. laws and company policies, including federal and state antikickback and false claims laws, the federal Food Drug and Cosmetic Act (FDCA) laws, the PhRMA Code, state laws, federal and state transparency laws.
• Manage budgets and external counsel activities.

Job Holder Requirements/Key competencies:

• Law degree from an ABA-accredited law school or equivalent degree earned in a non-US country.
• Licensed to practice law in one or more of the fifty (50) states within the US.
• At least ten (10) years’ experience in senior leadership roles within legal and compliance in life sciences.
• Prior in-house experience preferred.

• Fluency in English (working language)

Personal skills:

• High ethical standards and integrity and courage to speak up and voice dissent or concern.
• Perspective and judgment to assess what is really important and prioritize in a fast-paced environment.
• Composure and credibility when addressing challenge and conflict.
• Emotional intelligence, flexibility and solution orientation.
• Aptitude for problem-solving & resourceful thinking, ‘can do’-mentality.
• 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.
• Strong understanding of the functional operations within commercial, research and development, finance, quality and human resources in the life sciences space.
• Ability to communicate complex concepts in ways that are understood by cross-functional teams.
• Ability to cultivate strong stakeholder relationships and successfully influence senior leadership and peers.

Pharvaris is a late-stage, public 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

Pharvaris is a late-stage, public 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, Procurement & Logistics 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!

We are currently seeking a Manager, Procurement and Logistics Operations to join our team and take responsibility for the global execution of operational activities supporting Technical Operations Group and other functions. This position reports to the VP, Head of Project Management.

Location

Given the interactions of this role, we prefer this position to be based in the Netherlands or in Switzerland, preferably within 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.

Responsibilities

• 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

Requirements

• Bachelor’s degree in supply chain management, logistics OR in life sciences i.e.: chemistry, biology or similar
• 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).
• Advanced knowledge of MS Excel and prior exposure to ERP systems
• Knowledge of the global custom manufacturing market for Active Pharmaceutical Ingredients (API) and/or Drug Products is a plus

Pharvaris is a late-stage, public 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.

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 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.