Vice President, Head of Global Regulatory Affairs and Medical Writing

Generation Bio

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 04/07/2021
  • Website: generationbio.com
  • Company Address: 215 First Street, Cambridge, Cambridge, MA, MA 02142

About Generation Bio

Generation Bio is creating a revolutionary new class of genetic medicines that deliver durable, high levels of gene expression and have drug-like properties, including ability to titrate to effect and re-dose. Our unique GeneWave technology allows us to overcome the limitations of other approaches by delivering larger genes, including more sophisticated regulatory elements, and avoiding the immunogenicity which limits both the number of patients who can be treated and the ability to re-dose them over time.

Job Description

Description

Company Overview:

Generation Bio is an innovative genetic medicines company creating a new class of gene therapy utilizing our proprietary non-viral gene therapy platform to provide durable, redosable treatments for millions of patients living with rare and prevalent diseases. Our non-viral gene therapy platform incorporates our high-capacity DNA construct called closed-ended DNA, or ceDNA; our cell-targeted lipid nanoparticle delivery system, or ctLNP; and our established, scalable capsid-free manufacturing process. Using our approach, we are developing novel gene therapies to provide targeted delivery of genetic payloads that include large and multiple genes to a range of tissues across a broad array of diseases. We are also engineering our gene therapies to be redosable, which may enable individualized patient titration to reach the desired level of therapeutic expression and to maintain efficacy throughout a patient’s life.

We are initially focused on diseases of the liver and retina with significant unmet need for which our non-viral gene therapy platform may substantially improve clinical efficacy relative to current gene therapy approaches. We plan to expand our portfolio to include rare and prevalent diseases of the skeletal muscle, the central nervous system, or CNS, and oncology by developing discrete ctLNPs, each engineered to reach a different tissue. We believe our non-viral gene therapy platform may also allow patients to produce antibody therapies from their own cells for years at a time from a single dose, and plan to advance antibody gene therapy programs across multiple therapeutic areas.

 

Position Description:

Generation Bio seeks a motivated, flexible, creative and strategic individual to lead the global regulatory affairs and medical writing functions. This is a highly-visible and collaborative role that will shape the company’s strategic imperatives on our path to patients. He/she will be responsible for all regulatory aspects of preclinical, CMC, and clinical drug development. This includes developing and executing a comprehensive and strategic, patient-centered regulatory plan, as well as highlighting risks and opportunities to the senior leadership team. Medical writing responsibilities include building a team to ensure timely preparation, review and submission of clear and concise clinical and regulatory documents in compliance with applicable requirements. The ideal candidate is a senior regulatory leader who has a deep understanding of the regulatory pathways for gene therapies and/or nucleic acid therapies in the US and Europe, as well as direct or cross-functional experience with medical writing.

 

Primary Responsibilities:

  • Build an internal team responsible for all aspects of regulatory and medical writing, including regulatory strategy, regulatory CMC, regulatory intelligence and regulatory operations, utilizing consultants and outsourcing vendors as appropriate
  • Direct regulatory activities across the company’s portfolio, developing and implementing innovative global regulatory strategies, often where no precedent exists
  • Regularly monitor the evolving gene therapy landscape and advise company on relevant changes, including interpretations of any new guidance and regulations
  • Actively participate in key industry organizations, such as BIO and Alliance for Regenerative Medicine
  • Establish and maintain effective professional relationships with FDA and global health authorities; including facilitating, negotiating and resolving issues as needed
  • Serve as the Regulatory Affairs representative on cross-functional steering teams, such as the Development Integration Team and the Specifications Committee
  • Author and/or review portions of key regulatory submissions such as INDs / CTAs, meeting requests, briefing documents and responses to Health Authority questions
  • Collaborate with key functional areas including preclinical, CMC, program management, quality, clinical, and patient advocacy to ensure the regulatory strategies are aligned with the overall program goals
  • Provide regulatory oversight of program documents including target product profiles, development plans, and non-clinical and clinical protocols and reports
  • Ensure compliance with internal and external policies, guidance and regulations
  • Support or lead Due Diligence activities as appropriate

 

Required Skills:

  • Demonstrated ability to think creatively and strategically, and to interpret regulatory guidance and regulations for a novel modality, ideally with gene therapy and/or nucleic acid therapeutics experience
  • Strong scientific background, with ability to translate highly scientific/technical information to achieve regulatory objectives
  • Proven ability to develop and implement a regulatory strategy that evolves and proactively adapts to changes in industry standards
  • Deep knowledge of all facets of Regulatory Affairs
  • Experience leading Health Authority interactions
  • Ability to collaborate and lead cross-functionally and to develop strong relationships with partners both internally and externally
  • Ability to anticipate and recognize ambiguous situations, and to assess risk and make decisions in uncertain situations
  • Strong oral and written communication skills with the ability to lead and influence at all levels of the organization
  • Ability to proactively define, plan, communicate and manage multiple initiatives simultaneously to achieve objectives

 

Preferred Qualifications:

  • Advanced Degree (Biology or related Life Science) with 15+ years of relevant Regulatory Affairs and/or Medical Writing experience in the pharmaceutical industry
  • Prior experience in the gene therapy space

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