Pharvaris Careers

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 excited to be expanding our U.S. Commercial team and are looking for a National Account Director (Lead), to join our team and report to our Vice President, Head of Access, Trade & Patient Services.

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 need to be in the U.S. and preferably the Northeast Area.

The role

The National Account Director Lead (NAD) will be primarily responsible for managing business transactions and/or relationships with multiple types of payer accounts across geographies and will report to the Vice President, Head of Access, Trade & Patient Services. They will work as a player/coach while building a payer account team from scratch and being responsible for managing all segments of the market access business within their assigned geographic area while supporting and coaching their team. This person will work collaboratively across multiple functions including Sales, Patient Access, Gov’t Affairs, Trade, Advocacy, Market Access, and Medical.

The individual will provide updates, direction, and input to the Pharvaris leadership team and assist in the development of the overall market access strategic plan. The goal of the position is to minimize Pharvaris product access barriers and promote/implement various programs and services to supplement the field sales force and management efforts in maintaining patient access.

Responsibilities

• The NAD will be responsible for all segments of the market access business within their accounts including Commercial Payers, Medicaid, National MCO’s, Reimbursement Services and Programs, Federal Marketplace (VA/DOD), and Payer Specialty Pharmacies
• Lead, mentor, and develop a high-performing team of market access professionals to deliver on corporate objectives within the Market Access team while maintaining their own responsibilities for payer coverage
• Spend time in the field with national account team to support individual development, help with issue resolution as well as provide coaching, direction and feedback
• Responsible for key PBM/GPOs, State Medicaid programs, national and regional managed care organizations, Medicare, key Managed Medicaid Firms, and payer specialty pharmacies in their respective geographies
• Ensure rapid and optimal access for all products. Including creating and maintaining a Strategic Payer Account Plan and building strong relationships with senior managed care and pharmacy decision makers
• Gain vertical and horizontal access to various stakeholders within each account to manage; coverage policies, prior authorization/reauthorization processes, SoC provider relations initiatives and pharmacy department administration of medical & pharmacy benefit drugs utilization interventions
• Monitor and analyze national and regional healthcare policy trends, reimbursement changes, and payer decision-making processes (Commercial, Medicare, Medicaid)
• Develop an extensive understanding of the customers’ organizational goals in order to assess their needs and develop plans/programs to meet both the needs of the customer and those of Pharvaris
• Supports and implements strategy to meet or exceed goals of Pharvaris products for targeted accounts with a heavy focus on brand alignment, finance, and collaborating with key stakeholders
• Serving as the subject matter experts to communicate the value of the Pharvaris portfolio with payers and other organizations evaluating our portfolio for coverage or formulary inclusion

Requirements

• Bachelor’s Degree or equivalent, required
• 12+ years of pharmaceutical experience with broad experience across the commercial business with a focus in managed markets
• 10+ years of successful payer account management experience with strong payer relationships and rare disease launch experience preferred
• 5+ years of significant leadership and people management experience
• Strong understanding of reimbursement and control mechanisms by payer/PBMs
• Medicare Part D and Medicaid experience is a plus
• Excellent negotiation and/or major account selling skills
• Excellent communication (written & verbal), interpersonal influencing skills and prioritization skills
• Demonstrated ability to establish and maintain relationships with key customers and internal stakeholders
• Proven ability to stay up to date with the managed care industry and healthcare trends, including in-depth knowledge of the HAE market landscape
• Payer contracting and management experience

We are looking for someone that is/has

• Patient-first mindset with a sense of urgency to deliver results
• Self-starter and self-sufficient – able to develop account plans, hit deadlines and achieve clearly defined launch goals
• Work cross functionally with internal partners to achieve corporate goals
• Strong leadership experience with ability to build, coach, develop and mentor team members
• Creative, strategic thinker and problem solver – able to identify, develop, and execute sound account strategies
• Negotiating equitable contracts with key payer accounts, including PBMs and GPOs
• Understanding of payer decision-making processes
• Specialty pharmacy and reimbursement experience
• Knowledge of managed care operations

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. Commercial team and are looking for a Head of Patient Services, to join our team and report to the Vice President, Market Access, Trade, & Patient Services.

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 need to be in the US, preferably on the East Coast and/or greater Boston area.

The role

The Head of Patient Services will lead, build, and oversee the development, implementation, and management of a comprehensive patient support program to ensure patients have access to therapies and receive the assistance needed throughout their treatment journey. This role will collaborate closely with cross-functional teams including sales, marketing, market access, medical, legal, advocacy, and other Pharvaris leadership to establish and maintain effective and differentiating patient support strategies and resources.

Responsibilities

• Design, develop, and implement a patient support program CRM and HUB that facilitates seamless patient access and adherence to therapies
• Select and secure contracts with selected patient service build and support vendors (CRM, copay, telephony, translation, etc.)
• Lead innovation and drive program enhancements to optimize customer service and patient access to therapies by identifying emerging opportunities for a best-in-class program
• Ensure HUB performance is communicated to key stakeholders by developing and implementing performance dashboards and improvement plans as needed
• Collaborate with Commercial Operations to identify analytics to measure programs and assist the commercial business in driving data-driven decisions
• Monitor the effectiveness and overall performance of patient support programs and develop processes to increase the effectiveness and efficiency of the program services
• Ensure best-in-class systems and communication platforms for HCPs and patients
• Build and maintain program SOPs, business rules, workflows, call guides, training, and reports while ensuring operational compliance with industry regulations, company policies, and legal requirements related to patient support activities
• Collaborate with payer and field reimbursement teams to align patient services with market access and reimbursement strategies
• Lead the development of patient education materials, financial support, adherence programs, and other support tools in alignment with regulatory and compliance standards
• Initiate and manage partnerships with external vendors and service providers involved in patient support programs (i.e. CRM and copay vendor, etc.)
• Responsible for the operational oversight and day-to-day management of the Patient Services team, including development and ongoing management of goals and objectives setting for each employee, and performance coaching
• Developing, implementing, and leading training for all onboarding and ongoing training needs for the patient services team, including product knowledge, access and reimbursement

Requirements

• Bachelor’s degree in healthcare administration, business, or a related field; advanced degree preferred
• 12+ years of experience in rare disease patient support services or related roles within the biotech/pharmaceutical industry
• Demonstrated ability to build, implement, and lead a rare disease patient services team with strong patient focus
• Demonstrated leadership experience with a proven ability to build and lead a patient services team
• Strong strategic vision and a track record of developing and implementing patient-centric programs in rare disease
• In-depth knowledge of rare disease patient access services, compliance requirements, and market dynamics, including reimbursement and patient assistance programs
• A strong commitment to patient well-being and improving treatment journeys through innovative support services
• Proven ability to work effectively in a fast-paced, dynamic environment and drive results
• Solid understanding of the US healthcare system, patient assistance programs, and relevant regulations associated with patient privacy
• Excellent communication and relationship management skills
• Ability to manage budgets and optimize financial resources to ensure program sustainability and performance
• Up to 30% travel as necessary with Field Sales, Marketing, and Market Access to visit accounts and make presentations about the company’s reimbursement strategy and services; attend commercial and other relevant business-related meetings

We are looking for someone that is/has

• Strong patient focus and understanding of the patient journey
• Self-starter and self-sufficient – able to develop account plans, hit deadlines and achieve clearly defined launch goals
• Collaborate with internal team members (Marketing, Sales, Advocacy, Market Access, Medical, Compliance, Legal and Finance, etc.) to ensure intentional cross-functional planning and execution
• Strong leadership experience with ability to build, coach, develop and mentor team members
• A strategic, solution-oriented thinker with strong analytical skills and a patient-first mindset
• Understanding of payer decision-making processes
• Specialty pharmacy and strong reimbursement experience

Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2-receptor antagonists to potentially address all types of bradykinin-mediated angioedema. 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 diseases. 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. Commercial team and are looking for a Trade & Distribution Lead, to join our team.

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!

The role

The Trade & Distribution Lead will lead the development, implementation, and management of a comprehensive distribution model across the product portfolio to ensure patients have access to therapies and receive their treatment throughout their journey. This role will collaborate closely with cross-functional teams including sales, marketing, market access, patient support services, medical, legal, advocacy, and other stakeholders to establish and maintain, effective and differentiating product distribution, directly to patients.

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 role, you must be located in the U.S. with a preference for the East Coast.

Responsibilities

• Lead and oversee planning, program design development, vendor selection, contracting, and implementation of Distribution and Specialty Pharmacy programs to ensure patient access to Pharvaris products
• Collaborate and develop strong working relationships with Pharvaris cross-functional and commercial team members, including but not limited to: Marketing, Medical Affairs, Regulatory Affairs, Patient Advocacy, Patient Services, Supply Chain, Legal and Field Sales to ensure broad access to Pharvaris product(s); including external service providers to support broad patient access on a case-by-case basis
• Partner with the patient services team to ensure quality, efficiency and performance in delivering operational excellence and meeting Pharvaris standards to ensure patient initiation and support of ongoing treatment
• Serve as the internal expert and primary point of contact on all distribution and trade related issues; ensures relevant and timely access to Pharvaris products; provides input and feedback regarding contracting strategies and ensures that all contracting governance requirements are met
• Built a strong relationship with external partner(s) and managed performance against contractual arrangements (including KPIs) and budget, including coordination of Quarterly Business Reviews (QBRs)
• Strong collaboration with supply chain with shared responsibility of the 3PL to ensure supply requirements are met and Specialty Pharmacies have access to product
• Represent Pharvaris at trade functions, conventions and educational programs
• Collaborate with sales at district, regional and national sales meetings on education initiatives about trade, specialty pharmacy and distribution

Requirements

• Bachelor’s degree in a related business or scientific discipline
• Minimum of 12+ years progressively responsible commercial, including Trade and Distribution experience in a pharmaceutical, biotechnology or related environment with special focus in rare disease
• Prior buildout and leadership of an orphan drug distribution platform including trade/specialty pharmacy management
• Strong background and proven track record in working with specialty pharmacies to ensure execution and deliverables to support patient access and product supply
• In-depth knowledge of rare disease and insurance coverage requirements and the reimbursement process
• Extensive account management experience with strong relationships and familiarity with distribution vendors and suppliers of services related to enhancing product distribution to rare disease patients
• Experienced in complex contract negotiation and management
• Proven success in rare disease product launches and execution of Specialty Pharmacy services
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Ensure that all activities within the role of Trade & Distribution remain in compliance with all corporate, regulatory and legal guidelines
• Perform other tasks and assignments as needed and specified by management
• Travel requirements on average around 60%

We are looking for someone that is/has

• Self-starter and self-sufficient – able to develop account plans, hit deadlines and achieve clearly defined launch goals
• Work cross functionally with internal partners to achieve corporate goals
• Ability to anticipate issues and respond quickly, flexibly and creatively to solve problems and address commercial market challenges
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Creative, strategic thinker and problem solver – able to identify, develop, and execute sound account strategies
• Negotiating equitable contracts with key payer accounts, including PBMs and GPOs
• Savvy negotiator with excellent communication, written, and verbal skills with a background in successful payer contracting
• Understanding and navigating complex contract language and terms
• Understanding of payer decision-making processes
• Specialty pharmacy operations and reimbursement experience
• Knowledge of managed care operations

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%.