Medical Affairs Lead, (Senior) Director

The Netherlands, Switzerland
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 Medical Affairs Lead. Primary responsibility of the Medical Affairs Lead is to act as a bridge between internal Functions – particularly R&D and Commercial – and between internal and external Medical Experts/HCPs within the broader matrix of internal/external stakeholders and to contribute to establish Pharvaris as a scientific leader in bradykinin-mediated diseases including Hereditary Angioedema (HAE).

This includes building and maintaining trusted partnerships and collaborations with Key Medical Experts and other healthcare providers as well as with other key stakeholders to lead strategic planning, execution and support of medical education, evidence generation, scientific communication activities to enable access to treatments of people with HAE and other bradykinin-mediated conditions who need them. 

In order to achieve Functional objectives and to support achievement of corporate vision, the Medical Affairs Lead will work cross-functionally and actively lead cross-functional teams including internal Functions (Clinical Development and Operations, Regulatory Affairs), Commercial, Market Access, and Patient Advocacy and with external stakeholders (e.g., Medical Experts/HCPs, patient advocacy groups, Regulatory Agencies, Payers and other decision and policy makers).

This position equally requires strategic vision as well as strong operational skills.

Location

Flexible, ideally in Europe (The Netherlands, Switzerland). Pharvaris supports its staff to be home based and work virtually.

Core activities/ Areas of result

  • Working together with the Head of Medical Affairs, contribute to develop the Medical Affairs strategy and execution plan across the product portfolio and lead execution of Medical Affairs activities as well as actively contribute, as Medical subject matter expert, to cross-functional strategy planning and execution.
  • Represent the Medical Affairs Team in cross-functional strategic and operational decision-making forums – including the Product Program Team and up to the corporate Executive Committee, as needed – and actively provide Medical Affairs’ perspective, advice and expertise to identify opportunities and anticipate/mitigate risks with the objective of informing Medical and cross-functional decisions and delivering evidence-based solutions to eventually advance 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.
  • Further develop and evolve the Medical and Scientific Communication Plan and actively lead development and continuous update of medical resources supporting medical communication, scientific exchanges, and medical education of external and internal audiences.
  • Further develop and evolve the long-term Publication Plan across the portfolio – abstracts for scientific congresses, manuscripts – to establish Pharvaris as a scientific leader in HAE and bradykinin-mediated conditions. Actively lead planning and development of scientific publications to ensure balanced, evidence-based, and timely communication of data and findings from Pharvaris-sponsored trials and studies.
  • Further develop and evolve the 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 by Medical and cross-functional activities – these activities may require frequent travelling.
  • 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 may require frequent travelling.
  • Actively provide medical knowledge, expertise, and advice in processes related to development, implementation, and continued update of the evidence-based value proposition of Pharvaris’ investigational products and – upon regulatory approval – therapies and translate it into medical communication and education projects to ensure appropriate education of external audiences as well as provide Medical expertise to support cross-functional projects to ensure ability to access treatments for people with HAE and other bradykinin-mediated conditions who need them.
  • 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 the Therapeutic Area(s) of interest, including education on unmet needs, development, and clinical approaches with regards to treatment of HAE and other bradykinin-mediated conditions in clinical practice. Provide Medical subject matter expertise to cross-functional external stakeholder-facing activities and internal forums.
  • Identify key data and knowledge gaps and ensure knowledge and understanding to actively inform and influence planning, design and implementation of evidence-generation and medical education projects aimed at addressing the identified gaps, in collaboration with the appropriate internal Functions and/or external experts.
  • Support implementation of Pharvaris-sponsored clinical trials and studies by supporting medical education and scientific exchanges with clinical Investigators and Investigative Site Staff to ensure adequate knowledge of evidence from development of Pharvaris’ investigational products to inform appropriate selection and management of patients identified as eligible to clinical trials.
  • Support external-sponsored research projects (collaborative studies, investigator-initiated studies) in alignment with the identified areas of interest for external-sponsored medical research.
  • Implement and operationalize Patients’ Access Programs, as appropriate.
  • 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 (e.g., structure, procedures, performance indicators, engagement model) of Medical Affairs.
  • Ensure alignment of Medical activities with Industry and Pharvaris Compliance and Regulatory standards, policies, and regulations. Develop Medical Affairs standard operating procedures and other policy guidance documents and provide active Medical support to development of cross-functional policy resources.
  • Performs other tasks and assignments as needed and specified by corporate and functional management.

Candidate Profile

Professional Experience

  • MD and/or PhD in relevant fields with experience in Medical Affairs leadership roles in rare diseases. 7+ years of experience in Medical Affairs, including leadership roles in both country/regional as well as global teams at a (bio)pharmaceutical company in rare diseases. Experience in Hereditary Angioedema is a plus.
  • Excellent understanding of the pathogenesis and management of bradykinin-mediated angioedema & of the potential value of Pharvaris’ investigational products to address unmet needs in HAE and improve lives of people with HAE.
  • Track record of successful launch planning as well as preparation and execution of Medical Affairs and cross-functional pre- and peri-launch projects both at global and regional/country level.
  • Track record for successfully leading best-in-class Medical Affairs strategic thinking and external-facing operational execution, including but not limited to MSL leadership, development and implementation of scientific communication, scientific publication, and medical education strategy, plans, and resources through coordinating of internal resources and external partners.
  • 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.
  • History of successful collaboration with Development Functions to translate data and evidence from development programs into medical strategy-aligned, accurate, balanced, and stakeholder-relevant information.
  • Demonstrated ability to establish trusted relationships and partnerships with KMEs and clinicians through scientific engagement and to collect insights from real-world clinical practice to inform development of Medical and cross-functional strategies and translate them into actionable information to address stakeholders’ unmet needs.
  • Experience in acting as subject matter expert of medical-related content to address inquires of external stakeholders and to implement continuous training of internal Medical Affairs and ex-Medical Functional Leads.
  • Ability to leverage new technologies to innovate external and internal processes and implement medical affairs projects in the digital space.
  • 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.

Competencies and Skills

  • Proactive thinking and leadership of Medical and cross-functional decisions and execution of complex project execution, ability to early identify opportunities and risks as well as effective approaches to leverage/mitigate them, by also being willing to take reasonable risks.
  • Strategic thinking, business acumen, with proven ability to motivate, influence, negotiate, and collaborate with internal and externa stakeholders through efficient management of relationship within a cross-functional matrix.
  • Strong planning and project management skills, ready and willing to “roll up sleeves” and directly drive implementation and execution of projects.
  • Strong scientific/analytical problem-solving skills.
  • Ability to cope under pressure with conflicting priorities and to maintain an action- and result-oriented approach, high flexibility and ability to handle ambiguity & changes and operate in a rapidly-evolving environment.
  • Excellent communication and presentation skills to deliver strategic-aligned, effective presentation of complex projects to internal and external partners.
  • Readiness to travel frequently including for long-haul and -duration (>1 week) international and intercontinental business travels. Average travel time estimated to be ≥25% yearly, may be ≥50% on a monthly basis at the time of specific events (e.g., scientific conferences, business meetings). 
  • Complete fluency in English is a must.

how to apply

If you are interested to be part of a dedicated, global team at Pharvaris, please send your LinkedIn profile or resume to our HR department,

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