Head of Global Scientific Affairs

Avrobio

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 06/07/2021
  • Website: avrobio.com
  • Company Address: 1 Kendall Sq Bldg 300 Ste 201, Cambridge, MA, 02139

About Avrobio

AVROBIO’s vision is to bring personalized gene therapy to the world. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone.

Job Description


Key Responsibilities

    Knowledge base development

        Develop in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information

    Scientific communication strategy development and implementation

        Overall responsibility for the development and implementation of all scientific communications initiatives, with input from other team members and external agencies, as required

        Lead & manage key scientific communication initiatives including:
            Key scientific message bank & evidence base
            Publications plan, working closely with internal and external authors to facilitate the development of abstracts, posters, presentations, original manuscripts, review papers, case reports, etc.
            Publication library resources
            Congress plan, including identification of key congresses, milestone deadline dates and congress activities, including abstract submissions (as above), satellite symposia, meet the experts, competitive intelligence reporting, etc. Cover poster and scientific sessions at select medical conferences and write debriefs. Facilitate the development of congress presentations with external authors prior to and onsite congresses (e.g. slide reviews)
            KOL advocacy programs, including speaker bureaus, advisory boards, advisory board reports, etc
            Review corporate communications and IR materials, including press releases,  backgrounders, FAQ, etc., for medical accuracy
            Working with Director of Patient Advocacy, collaborate on patient initiatives
            Digital initiatives for the presentation and sharing of key scientific data
            Medical communication/education tools for internal and external use, including slide decks, standard response / FAQ documents, etc, for a range of stakeholders, including investor relations and medical information purposes
            Working with the SVP of Corporate Communications, support internal scientific and corporate communications initiatives
            Contribute to providing medical content of regulatory/SEC filings
        Work with clinical team at conferences to foster relationships with key opinion leaders and as AVROBIO grows, contributions to staffing scientific information booths

    Cross-functional team liaison

        Collaborate with multiple functional teams, including Clinical and R&D, to identify available data and publications into medical communications and educational resources, as well as other team members, including the Director of Patient Advocacy
        Act as a resource to others external to the clinical team
        Represent medical scientific communication and information function at internal meetings

    External agency/vendor liaison

        Manage all external agencies/vendors involved in the development and roll out of all scientific communication initiatives, as required

    Lead internal scientific communication review & QC processes

        Represent medical scientific communication and information function at internal meetings
        Review/approve all externally-developed communications materials (e.g., those prepared by freelancers, agencies, etc.)
        Review/approve all external scientific communications materials to ensure all meet the necessary regulatory and legal requirements (adherence to GPP2, ICMJE, national/local regulations, etc.)
        Launch and manage scientific communications functional operations, through development of SOPs / work processes and recruitment of additional key medical talent, when required

Minimum Requirements/ Qualifications

    Advanced, doctoral level degree preferred. PhD, MD, MSc/MPH, PharmD, with 8+ years of experience within a pharmaceutical company environment required
    Gene therapy and rare disease experience preferred
    Excellent management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
    Passionate commitment, detail-oriented and a strong team player
    Ability to work independently and reliably deliver objectives of high quality in a timely manner
    Experience in all stages of drug development
    Strong Global clinical research experience and working as part of a cross functional clinical team
    In-depth knowledge of the regulatory path across the various health authorities (FDA, EMA, PMDA, etc)
    Demonstrated ability to quickly understand and apply scientific concepts in a clinical setting.
    Able to evaluate, interpret and synthesize scientific data, and verbally present and critically discuss clinical trial data in internal and external meetings
    Excellent verbal and written communication skills

About AVROBIO

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.