Pharvaris Careers

Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks. By targeting this clinically proven therapeutic target with novel, oral small molecules, the Pharvaris team is advancing new alternatives to injected therapies for all sub-types of HAE 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.

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 lead programs aimed at bringing new, novel oral options to people living with hereditary angioedema (HAE), we have an opportunity for a highly driven, Regulatory Affairs Senior Manager/Associate Director to join our team and help implement our regulatory affairs (RA) strategy and vision.

If you are an innovative and enthusiastic RA professional – inspired by building effective solutions and passionate about balancing pragmatism with high quality – this could be the role for you.

As a Regulatory Affairs Senior Manager/Associate Director, you will be responsible for contributing to global RA projects for late-stage development products in the rare disease space, including a potential New Drug Application (NDA) with the opportunity to collaborate on early-stage development projects. You will have the opportunity to develop and implement complex global regulatory strategies including health authority interactions, submission documents, and global regulatory filings, as a key strategic member of the regulatory team. You will support in implementing departmental strategies and policies.

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 and the teams you will be working with, this position will be based in the U.S., preferably on the East Coast (EST time zone, CT time zone acceptable).

Scope

• Serve as regulatory affairs representative to provide input on global clinical trials, including coordination of health authority requests, filing activities, and ensuring that documentation and reporting systems are maintained and compliant
• Ensure the U.S. regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions
• Contribute to the strategy for U.S. FDA interactions with the cross functional team, including development of content, format, and accountability for regulatory submissions and related supplements and amendments, such as FDA meeting requests, briefing books, meeting minutes, orphan drug annual reports, and DSURs
• Support maintenance and organization of regulatory documentation in partnership with regulatory operations and other teams
• Support U.S. labeling development for NDA
• Deliver regulatory achievements for assigned project(s), including the assessment of risks with mitigation strategies, emerging data, and the probability of regulatory success
• Develop collaborative and effective relationships across key internal and external partners (e.g. regulatory CMC, regulatory operations, CROs/vendors) to enable rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support and documents in support of global regulatory submissions, health authority meetings and requests, and securing approvals
• Lead cross functional teams, in partnership with global regulatory lead, to develop and execute regulatory strategies for assigned projects and programs

 Requirements/Key Attributes

• Master’s or above degree in Pharmacy, Chemistry, Biochemistry, Biology or Biotechnology (or comparable preferred), bachelor’s degree in scientific field required
• 8+ years’ experience in drug development, 5+ years in regulatory affairs, rare disease experience preferred
• Experience as direct contact with Major Health Authority desired
• Previous experience in developing materials, attending, and supporting team preparation for Major Health Authority interactions
• Strong experience with CTD format and content of regulatory filings for INDs, NDA/BLAs, MAAs, including developing strategy, writing, and reviewing documents
• Strong organizational skills, ability to multi-task and manage workload independently
• Detailed knowledge of regulatory drug development including product approval and maintenance
• Ability to think strategically and critically evaluate risks to regulatory activities
• Ability to work strategically within a business-critical and high-profile development program
• 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 leaders must take a hands-on approach to get results
• Excited and driven by science and the vision to improve disease management and patient care

Interested?
Please send your resume to [email protected]. We look forward to speaking to you.

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.