Pharvaris is a public and clinical stage company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases. To support our lead program aimed at bringing new, oral options to patients suffering from hereditary angioedema (HAE), we offer an opportunity for a highly motivated Paralegal to join and help drive bringing solutions to patients.
This role is based in the US, preferably East Coast. 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.
As our Paralegal, you will be part of the Legal & Compliance team at Pharvaris and to support the Chief Legal Officer & Corporate Secretary.
In this role, you will contribute to the team’s growth and ability to provide efficient and effective support across Pharvaris.
Key Characteristics of the job (Objectives and Responsibilities)
- Support our secretarial function, including preparing notices, agendas and meeting materials for the annual shareholders’ meeting, board of directors and related committees and maintaining corporate resolutions, minute books, calendars, and records
- Drive logistics (venue booking, travel arrangements for participants, expense reimbursement management for Board of Directors, …)
- Assist with managing national and international corporate entities, including preparing subsidiary board materials, and managing state and local filings for various entities.
- Coordinate with the Corporate Communications and Finance function and assist in preparing public disclosure documents, including SEC periodic reports such as 20Fs, 6Ks, proxy statements and other related documents.
- Assist as needed on special projects, including mergers & acquisitions and financings
- Support Contract Lifecycle Management including contract processes, contract management system and templates.
- Acts as an information source on legal and compliance policies and procedures for the wider organisation.
- Provide full administrative support to CLO, including
- Support CLO with budget management, billing, and external counsel management.
- Assist with scheduling and coordinating meetings, trainings, and other team activities.
- Travel arrangements and expense report preparation
Job Holder Requirements/Key competencies:
- Education: Bachelor´s Degree or equivalent work experience in a relevant discipline
- Minimal work experience: Five (5) to seven (7) years’ experience in a support role, preferably in a corporate environment and legal & compliance team
- Advanced skills with Excel and other Microsoft Office products
- Fluency in English (working language)
- Exceptional organisational skills, taking high pride in being accurate and detail oriented.
- Proactive and excellent ability to initiate and self-start projects – able to work well independently
- Demonstrated ability to thrive in a fast-paced environment
- Having a ´can do, roll up my sleeves´ mentality, with an excellent ability to prioritize effectively & ruthlessly to meet multiple tight deadlines
- Being a confident communicator and team player who can build strong working relationships across the organisation and with external partners
- Feeling comfortable handling ambiguity & change
- Being an avid and quick learner, not afraid to ask questions
How to apply
This role is based in the US, and reports to our Chief Legal Officer & Corporate Secretary. We offer talented staff a great working environment, dedicated and driven co-workers, short lines of communications and an attractive compensation package.
Clinical Quality Assurance Director
Pharvaris, a public and clinical stage company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, has an opportunity for a highly motivated Clinical Quality Assurance Director to join and help drive bringing solutions to patients
This role is based in Europe, this may be Leiden, NL or Zug, CH or in the Boston region, US. Pharvaris supports its staff to be home based and work virtually.
The CQA Director will lead quality activities and be responsible for establishing and leading the Clinical QA function. This position will oversee the global GCP and Clinical Quality function and represent the company as the key CQA liaison with external vendors and CROs. The incumbent will be responsible for the company’s clinical quality systems and compliance strategies involving clinical trials and global marketing preparations. The Director will also be expected to work with key business partners to assure compliance with GCPs and GLPs in an effective and efficient manner. The incumbent is responsible for evaluating and ensuring compliance of clinical studies with global regulatory agencies.
The Director will provide oversight of Clinical QA systems and ensure compliance with clinical research activities. The candidate must have the ability to develop and implement GCP-related quality systems and training of staff and be able to oversee audit plans and activities so as to conduct effective audits of investigator sites, documents, Trial Master Files, vendors, and internal and external processes.
The CQA Director will be responsible for planning, coordinating, controlling, and continuously improving the internal GCP-QA processes and systems. They will assure quality awareness in conducting clinical studies and convey confidence in clinical knowledge providing a strong understanding of clinical processes. The Director will be expected to routinely interact with external partners to promote collaboration and ensure all systems, processes, and their outcomes are compliant with applicable international standards, regulations and guidelines. The candidate should have the ability to actively leverage audit outcomes and trends to inform improvements in conducting clinical trials and reporting while championing the highest standards of compliance.
- Identify and communicate GCP quality and compliance risks and implement appropriate plans for resolving issues and addressing risks
- Develop and provide training on GCP topics
- Identify Quality processes/system that require implementation or improvements
- Work with the Clinical Operations team to develop and maintain audit programs for clinical sites with appropriate risk assessment and mitigation
- Plan, conduct and report on GCP audits of clinical investigators, vendors, systems as well as key reports and documents to facilitate regulatory inspections
- Prepare and revise GCP SOPs and Work Instructions as well as creation and maintenance of audit tools
- Represent GCP QA on project teams to facilitate audit planning both internally and externally
- Work with cross-functional teams to provide GCP advice and provide guidance on risk- based QA audit options
- Review clinical study documents and check for consistency and appropriate standards and practices
- Bachelor’s degree life science
- 5+ years of direct GCP QA experience with a least 10 years in pharmaceutical/biotech industry, trained and certified GCP auditor.
- Language fluency in English
- Personal skills and other competencies, as needed: goal-oriented, completer/finisher, recognition of inter-cultural differences
- Experience to work in a matrix, ability to influence without authority
- Demonstrated record of team skills: comfortable in an interdisciplinary and international environment and able to communicate effectively and to collaborate in a team
- 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
- Ability to multi-task and manage workload independently
Director, Corporate Development
Pharvaris, a public and clinical stage company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, has an opportunity for a highly motivated Director, Corporate Development to join and help drive our corporate development to bring more choices to patients.
Reporting to the Chief Business Officer, the Director will work closely with internal and external senior leaders to successfully support overall corporate development goals including preparation, sourcing, negotiation, and execution of transactions supporting R&D and commercial.
Flexible, ideally in United States or in Europe (Switzerland, the Netherlands). Pharvaris supports its staff to be home based and work virtually.
- Develop and maintain an expert understanding of the scientific and asset landscape and competitive intelligence to ensure visibility to emerging opportunities and changes in the environment
- Identify & source compelling external opportunities; lead the review of R&D stage opportunities to assess their viability and drive to a prioritization decision.
- Design partnership roadmaps, conduct initial outreach to prospective companies, and advocate to senior leadership for specific deals in support of portfolio and business team priorities
- Follows up on all partnership activity including the tracking, documentation and status reporting of all collaborations along the business development pipeline
- Serve as the liaison with the third party for all interactions that progress beyond initial review
- Build and maintain valuation, statistical and financial models that incorporate industry standard information sources, valuation methods, and statistically relevant data
- Manage the preparation of term sheets, contracts, business cases, valuation models and other materials in collaboration with Legal, IP and other functions as required
- Manage necessary cross-functional due diligences and will collaborate with cross-functional teams to deliver and execute eventual deals and manage any transition to the alliance management function
- Support deals and contract in partnership with legal, finance and other areas
- Establish and strengthen relationships with potential external partners
- Minimal Bachelor’s degree in science or related field; advanced scientific degree relevant to pharmaceutical R&D (PhD, PharmD or MD) strongly preferred
- Strong track record of success in positions of increasing responsibility; minimum of five years of broad-based business experience; relevant experience includes, but is not limited to corporate or business development/planning, corporate strategy, consulting, or investment banking
- Experience in biotech or pharma deal making, including opportunity sourcing, due diligence, asset valuation, deal structuring, and negotiations
- Robust understanding of the full drug development process, life-cycle management, and commercialization of therapeutics
- Proficient biopharma commercial/market awareness with good understanding of key drivers that underpin commercial assessments and valuations
- Strong skills in representing business cases and driving timely and smart decisions across complex internal and external organizations
- Excellent planning and organization skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
- A team player with demonstrated ability to align people and resources towards organizational success
- Ability to thrive in a dynamic environment with high level of agility; a wide degree of creativity and strategic thinking is expected
- Excellent executive communications skills – both oral and written
- 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.
- Ability to multi-task and manage workload independently