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    GCP Oversight and Compliance Lead - Boston, United States - Pharvaris

    Pharvaris
    Pharvaris Boston, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    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 oversightof 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
    • Foster a team culture of engagement, accountability, collaboration, innovation, sense of urgency to serve patient needs and achieving Pharvaris corporate vision.
    • Perform 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
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