Head of Regulatory

Research & Development Cambridge, Massachusetts


Description

Company Overview

Repertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease.  The company is founded on the belief that the repertoire of T cell receptor (TCR)-antigen codes that drive health and disease represents one of the greatest opportunities for innovation in medical science.  Repertoire scientists created and developed the DECODE and DEPLOY suite of technologies, which allow in-depth characterization of TCR-antigen pairs, and the ability to rationally design and develop novel targeted immune medicines.

From its sites in Cambridge, Mass., and Zurich, Switzerland, Repertoire’s team of more than 120 is creating a new category of immune medicines enabled from its DECODE discovery platform.  The company’s first product in the clinic is a novel multiclonal T cell therapy consisting of T cells derived from the peripheral blood, activated against a curated set of antigens, and armed with a proprietary cytokine.  Repertoire is in clinical-stage immuno-oncology development today, targeting metastatic solid tumors.  In the field of autoimmunity, Repertoire is currently using its proprietary platform to discover novel epitopes and TCRs from patients with type 1 diabetes.  However, we are currently expanding our remit into other autoimmune disorders.  The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.

Role Overview

The Head of Regulatory will report directly to the Chief Medical Officer (CMO) and be responsible for all aspects of Regulatory Affairs related to clinical development, CMC, and future commercialization.  This leader will drive the strategic direction and operational aspects of regulatory compliance and submissions for all programs across Repertoire Immune Medicines including CMC, discovery, preclinical, and clinical.  The position will be responsible for developing the strategic plan for obtaining approval for compounds in the pipeline and for developing strong relationships with the FDA and other global regulatory agencies.  The candidate will also be responsible for building the appropriately sized internal support and managing the external support to implement and execute the strategic plan to ensure rapid and timely approvals that will lead to the achievement of Repertoire’s business objectives.

Key Responsibilities

  • Provide leadership and oversight for all regulatory submissions, regulatory compliance, regulatory advice, and counseling in all areas of development and commercial regulatory activities across the lifecycle of products for the U.S. and globally.
  • Partner with and support clinical development, CMC, preclinical, quality, medical affairs, commercial and corporate activities including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
  • Develop and design robust regulatory organization, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.
  • Act as primary strategic contact with the FDA and other regulatory agencies, as applicable, to enable execution of company regulatory goals.
  • Foster a strong relationship, partnership, and advocacy with the FDA and Global Health authorities including as it relates to innovation in therapeutic platforms and approaches.
  • Provide guidance to business development regarding critical evaluation of potential product opportunities supporting strategic partnering and licensing activities.
  • Develop and plan innovative regulatory strategies for label enhancements and life cycle product management collaboratively with project team members.
  • Provide regulatory strategic leadership supporting commercialization and post-marketing activities and requirements for approved products.
  • Build and manage a team of U.S. Regulatory staff and support functions including full time staff and independent consultants based on the stages of the business. 
  • Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future company products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
  • Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Repertoire employees and assist as a liaison between Repertoire and regulatory authorities.
  • Communicates complex and unusually complicated regulatory information and tactical issues to management.
  • Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
  • Works collaboratively with clinical development functions and other early development functions to help design integrated product specific development plans.

Qualifications/Experience

  • Minimum 10 years’ of experience Regulatory Affairs within the biotechnology industry with 7 years’ of specific leadership and/or management experience.
  • Experience leading, designing, writing, and submission of regulatory filings and correspondence and/or approvals is required, including within the Oncology space.  Experience in the cell therapy space is preferred.
  • Experience leading the submission process for INDs, new entities, and line extensions of existing products preferred.
  • Experience supporting commercialization and post-marketing activities and requirements for approved products in North America is preferred.
  • Strong collaboration, leadership competencies, and strategic business perspectives are required to ensure that sound drug development and regulatory compliance practices are fully integrated in all clinical studies, clinical development, and post-marketing activities.
  • Strong understanding of the global pharmaceutical drug development and regulatory environment particularly within the FDA.
  • Experience and/or active involvement in joint ventures, highly collaborative partnerships, and in/out-licensing business opportunities is a plus.
  • Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
  • Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards.
  • Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused with the ability to think strategically as well as execute project details.
  • In-depth understanding of the drug development, product commercialization, and life cycle management processes combined with experience in Quality Assurance, Development, Clinical, and Compliance is desired.
  • Has evidence of strategic regulatory thinking: working collaboratively to create novel, creative solutions to regulatory issues.
  • Strong collaborative and transformational leadership skills with potential for further growth.
  • Has integrated “end to end” (discovery to commercialization) mindset.
  • Exposure or working knowledge to systems thinking preferable.

 

Repertoire is committed towards social responsibility and developing an inclusive culture.  Much as the power of the immune system lies in the diversity of T and B cells, we believe that our work requires the creativity and ingenuity of a diverse workforce, and we are committed to pursuing that in all facets of the work experience at Repertoire.  We will continue to educate ourselves about the inequities and barriers present in our society and act as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.