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Associate Director, Regulatory Patient Engagement & Outcomes Research

Location United States, Remote

Workstyle Remote Only
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

Overview

BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.

BioMarin Regulatory Patient Engagement & Outcomes Research (PEOR) team develops and executes the global Patient Engagement & Outcomes Research strategy for relevant programs. The team provides subject matter expertise to support the selection, incorporation, and evaluation of Clinical Outcome Assessments (COAs) for use across programs and ensures early development and implementation of robust plans to ensure COAs satisfy regulatory standards and support product approval. Additionally, the PEOR Team leads the Regulatory Patient Engagement strategy to bring the patient voice to the forefront of program development to meet regulatory goals.

Summary

The Associate Director is responsible for the development and implementation of US and EU regulatory Patient Engagement & Outcomes Research strategy, for assigned programs, to ensure successful COA measurement strategy implementation and that the patient voice is incorporated in program development and the regulatory process. This person is required to employ an advanced strategic planning, decision-making and leadership skillset to strongly influence internal colleagues and stakeholders. A well-developed ability to communicate and proactively navigate change while maintaining internal alignment on Patient Engagement & Outcomes Research strategy is important.

The BioMarin Associate Director is viewed as a subject matter expert in the functional area involved in developing, modifying and executing Patient Engagement & Outcomes Research strategies that may have a companywide impact.  The AD will typically collaborate with and influence internal colleagues across functions and meet with external stakeholders, remaining aware of regulatory and patient influences.

Responsibilities 

Patient Engagement & Outcomes Research Leadership

  • Oversight, development, and implementation of forward-looking regulatory PEOR strategy across programs
  • Provide subject matter expertise to support the selection, incorporation, and evaluation of clinical outcome assessments (COAs) for use across programs
  • Ensure early development and implementation of a robust plan to ensure COAs satisfy regulatory standards and support product approval
  • Provide input into protocol development to ensure key regulatory guidance and precedents are incorporated into decision making
  • Provide input on Statistical Analysis Plans (i.e. contribute to COA data analysis plans)
  • Lead the development of supportive documentation for submission, ensuring document is aligned with strategic focus and in line with the overall program, and ensuring the quality of the document is appropriate for submission (e.g. evidence dossiers for regulatory submission)
  • Responsible for the COA sections of regulatory submissions, ensuring data accuracy, messaging is in line with strategy and that quality is appropriate for submission
  • Represent the PEOR team as needed on the Real-World Evidence workstream
  • Represent the PEOR team on the GRT, including sharing essential communications to the GRT and feeding information back to the PCOR team
  • Represent the PEOR team in other internal meetings, and externally with regulators
  • Act as PEOR SME in cross-functional settings (e.g., with market access, clinical, commercial, medical affairs, global patient advocacy & engagement teams)
  • Stay informed on regulatory and outcomes-specific organizations
  • Responsible for the development and implementation of US and EU regulatory patient engagement strategy, for assigned programs, to ensure the patient voice is incorporated in program development and the regulatory process
Education & Experience 

  • A Master’s or doctoral degree in the field of Epidemiology, Public Health, Psychology, Psychometrics, Health Research, clinical (medicine, pharmacy or nursing) or related is required
  • 5 + year experience with PhD; 8+ years with Master’s
  • Experience in Patient Focused Drug Development, including Outcomes Research or other Regulatory affairs related function at a global pharmaceutical or biotechnology company. Experience interacting with regulators, policy makers, and experts in the field is preferred.
  • 2+ or more years of line management experience preferred

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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