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 U.S. (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 medical team and seeking to therefore hire a Senior Medical Science Liaison, to join our Medical Affairs team and report to our Head of North America Medical Affairs.

The title of MSL or Sr MSL will be based on the candidate’s experience.

Location

This role is preferably based in The United States (Remote: Preference West Coast – CA, CO, UT, AZ and neighboring states – 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 KOLs/HCPs at major hospitals and rare disease centers. At Pharvaris, we promote and enable a flexible hybrid work-environment and support our talents to be home based and work virtually.

Responsibilities

• Serve as the field-based extension of the Pharvaris Medical Affairs Team.
• Systemically proactively identify the scientific exchange needs of Key Opinion Leaders (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.
• 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 Medical and Commercial do 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.
• Conduct training for Commercial and Medical colleagues as needed.
• Participate in cross-functional team projects as needed, for example in the creation and implementation of SOPs.
• Proactively identify process improvement opportunities which align with business needs, and propose and deploy solutions as needed.

Requirements

• MD, PharmD or PhD preferred.
• Master’s degree or NP in life sciences, or MPH can also be considered, if the candidate possesses strong relevant work experience.
• 5+ years of experience of MSL experience with primary emphasis on rare diseases and field based scientific exchange.
• Clinical trial support experience is a plus.
• Preference for candidates who have worked for emerging biopharmaceutical companies in the past, with evolving operating procedures and employee remits.
• Preference for candidates who have developed expertise in hereditary angioedema (HAE) in an academic or professional setting.
• Excellent communication skills and ability to exchange scientific ideas and information openly and effectively with KOLs and colleagues.
• Track record of creating and deploying scientific presentations to individual HCPs, Payers and groups of internal and external stakeholders in virtual and in-person settings.
• Demonstrated ability to proactively assess available resources (including the selected candidate’s own bandwidth) and suggest remedies when conflicting priorities arise.
• Positive attitude and ability to proactively solve problems, even in the face of adversity.
• Demonstrated current knowledge of relevant guidelines and regulations.
• Ability and desire to travel on a regular basis (up to 80% of working time).
• Availability to attend meetings on weekends.
• Clean and valid driver’s license.

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!

If you are a detail-oriented drug development professional with a service minded attitude – passionate about 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 Project Manager to join our team and take responsibility for driving and supporting the global program teams and non-program projects to deliver on the company ambitions. This position reports to the VP, Head of Project Management.

Location

This role is preferably based in the Netherlands or 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

• Support program teams and Global Program Leads with organization of meetings, preparing and following up on agenda, minutes, actions and decisions
• Manage programs and non-program related projects to deliver within scope, time and budget and maintain stakeholder communication
• Integrated project planning (timelines, milestones, interdependencies) and identification/management of critical path
• Identification, consolidation and monitoring of risks and issues, including mitigation and contingency plans
• Continuous improvement of project management (tools) in the organization, advocate for best practices and act as change agent
• Support in budget development, planning and tracking by acting as the liaison between the functions and finance, and supporting in the procurement and PO processes in the ERP system

Requirements

• Advanced degree in life sciences discipline, or equivalent by experience
• 10+ years of experience in life sciences (Pharma / Biotech preferred) product development, of which at least 5 years in project management
• Knowledge of the overall pharmaceutical development process over the products life-cycle, from phase 1 to launch and beyond, including regulations
• PMP certification or similar is a plus
• Excellent communication skills to excel in cross-functional teams
• Excellent organizational skills, process oriented and attention to detail
• Knowledge of project management tools, including principles of strategic planning, conflict resolution, negotiation skills, costs monitoring and organization responsibility charts
• Open personality with proven team spirit and 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 verbal and written communication and presentation skills (English)

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 an Sr. Mgr. Regulatory Affairs CMC Writer, to join our Regulatory Affairs team and report into our 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. The United States (East Coast) is a secondary location where we may also consider candidates. 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 MS, PharmD or PhD preferred
• 5+ years of experience within Regulatory CMC in a pharmaceutical or biotechnology setting
• Prior experience with FDA related submissions is required, prior experience with EMA and local market 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 mgmt. 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), 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 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 in the Regulatory function and seeking to therefore hire a Director, Regulatory Operations, to join our Regulatory Affairs team and report to our Vice President, Head of Regulatory Affairs & Quality.

The Director, Regulatory Operations will lead global regulatory operations, overseeing the submission process for regulatory filings and ensuring compliance with regulatory requirements. This role will provide operational oversight and support in the preparation and implementation of the regulatory strategic and operational plans. This role will be responsible for the launch and maintenance of RegDocs Connect RIM (Regulatory Information Management) system. The successful candidate will have a background in non-Veeva RIM systems, as well as experience in filing NDAs and MAAs with an external publishing vendor.

Location

This role is preferably based in The United States (Remote: Preference 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

• Provide regulatory operations expertise and leadership to cross functional teams supporting the pipeline, train and lead regulatory operations personnel reporting into this role.
• Lead the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. As needed, train colleagues and project teams.
• Oversee full implementation, maintenance & optimization of a RegDocs Connect RIM system.
• Provide RIM system leadership by overseeing the development of RIM projects based on current and future business needs optimizing use of system attributes
• Oversee and manage all Regulatory Operations global submissions, systems related projects and submission compliance.
• Oversee management of external publishing vendor.
• Ensure proper maintenance of regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions.
• Oversee build of submission binders & content plans for future regulatory submissions globally.
• Stay current with regulatory requirements and industry best practices.
• Prepare and present regulatory reports, metrics, and dashboards.
• Lead budgeting and forecasting activities for the Global Regulatory Operations function including managing vendors.
• Proactively identify process improvement opportunities which align with business needs, and propose and deploy solutions as needed.

Requirements

• Bachelor’s Degree in life sciences or related field is strongly preferred.
• 10+ years of work experience in pharmaceutical/biotech regulatory affairs, with at least 8 years of Regulatory Operations experience.
• NDA/MAA filing experience.
• Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing and electronic document management systems
• Understanding of drug development and business processes.
• Knowledge and experience of eCTD submissions.
• Knowledge of FDA, EMA, and ICH guidelines.
• Proven internal and external leadership with ability to work cross-functionally and globally.
• Possess strong communication and interpersonal skills with excellent attention to detail.
• Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to foster effective relationships and collaboration, motivate others, influence without authority via proven project management and time management skills.
• Extensive knowledge in the implementation of GxP Systems (e.g. Document Management Systems) and formatting solutions (e.g. authoring templates)]
• Clear understanding of the role that Regulatory Systems and user adoption plays in creating Regulatory efficiencies.

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.

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, 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.