Director, Patient-Centered Outcomes

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Provides strategic and scientific guidance for patient-centered outcomes initiatives.

• Ensures that research designs, execution, and evidence packages are appropriate for client decision-making and regulatory purposes.

• Oversees clinical outcome assessment projects, which include literature reviews, gap analyses, COA development and modifications, in-trial interviews, regulatory strategy, and dossier preparation.

• Establishes scientific methodologies by converting client goals into customized research designs and evidence-generation plans.

• Develops endpoint and regulatory strategies for COA evidence packages that support labeling claims.

• Directs project teams by defining methodological approaches, confirming data requirements, and ensuring deliverables meet research questions.

• Reviews analyses, data interpretations, and client deliverables to ensure scientific integrity, accuracy, alignment with scope, and intended use.

• Facilitates client interactions, outlines options, communicates recommendations, and aligns stakeholders on research and evidence-generation decisions.

• Guarantees timely and high-quality delivery across the project portfolio, oversees execution, and makes adjustments as necessary to meet annual revenue goals.

• Grows existing accounts and cultivates new client opportunities.

• Leads proposal creation, including defining scope and budgeting, and meets annual sales targets.

• Provides guidance and relevant technical training to junior project team members.

⛳️ Requirements

• A Master’s or Doctorate degree in a health-related field is preferred but not mandatory.

• At least 8 years of progressive experience in leading PCO and COA research, with responsibility for the scientific and strategic direction of endpoint evidence generation to support medical product labeling claims.

• Proven expertise in developing COA strategies based on literature reviews and gap analyses, providing strategic insights aligned with the client’s clinical, regulatory, and reimbursement goals.

• Demonstrated proficiency in qualitative research and COA-focused methodologies, including standalone COA development/modification studies and the design, implementation, and execution of clinical trial interviews.

• Proven ability to devise endpoint and regulatory strategies for assigned projects by applying regulatory guidance and precedents to evidence plans, regulatory support interactions, and documentation.

• Expertise in methodologies necessary to deliver additional PCO services, including Delphi panels and survey research, patient preference studies, discrete choice experiments, and goal attainment scaling; this is desired but not mandatory.

• Comprehensive understanding of the drug development process, including experience working with regulators on COA development and generating evidence to support medical product labeling claims.

• Demonstrated capability to lead multidisciplinary project teams while managing multiple concurrent engagements, ensuring scientific quality, adherence to timelines, and effective decision-making.

• Strong analytical and writing skills, including the ability to synthesize complex evidence into clear and actionable client recommendations and suitable deliverables.

• Excellent client-facing communication skills, with the ability to lead discussions with senior stakeholders, present recommendations, and address complex scientific and strategic inquiries with clear, well-supported answers.

• Proven ability in business development, including leading proposal scoping and budgeting, and contributing to sales and revenue growth.

🏝️ Benefits

• Competitive salary along with a bonus scheme.

• Options for medical, dental, and vision insurance.

• 401(k) plan with employer matching contributions.

• Flexible paid time off program plus 10 paid holidays.

• Flexible spending accounts for health and dependent care.

• Health savings account option with employer contributions.

• Employee Assistance Program.

• Paid short-term and long-term disability coverage.

• Company-paid life insurance coverage at 1.5 times annual salary.

• Paid parental leave and additional benefits.