Director – Patient-Centered Outcomes

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

📋 Description

• Deliver strategic and scientific leadership for patient-centered outcomes initiatives.

• Convert client goals into customized research frameworks and evidence-generation strategies.

• Formulate endpoint and regulatory strategies for clinical outcome assessment evidence packages that support labeling claims.

• Oversee literature reviews, gap analyses, COA development and adjustments, in-trial interviews, regulatory strategy, and dossier preparation.

• Specify methodological approaches, validate data needs, and ensure deliverables effectively address research inquiries.

• Evaluate analyses, data interpretations, and client outputs for scientific rigor, accuracy, scope, and intended application.

• Guarantee adherence to the PCO Quality Management System and relevant SOPs.

• Facilitate client engagements, outline options, convey recommendations, and align stakeholders.

• Supervise project milestones, decision-making points, execution, and adjustments across the project portfolio.

• Propel account growth, identify new client prospects, develop proposals, scope projects, budget effectively, and drive sales and revenue growth.

• Offer guidance and technical training to junior project team members.

⛳️ Requirements

• Master’s or doctorate degree in a health-related discipline is preferred, but not mandatory.

• At least 8 years of progressive experience in leading PCO and COA research, with a focus on scientific and strategic oversight of endpoint evidence generation for medical product labeling claims.

• Proficient in crafting COA strategies based on literature reviews and gap analyses.

• Experienced in qualitative research and COA-centered methodologies, including independent COA development/modification studies and clinical trial interviews.

• Capable of developing endpoint and regulatory strategies utilizing regulatory guidance and precedents for evidence plans, regulatory interaction support, and documentation.

• Knowledge of additional PCO methodologies, such as Delphi panels, survey research, patient preference studies, discrete choice experiments, and goal attainment scaling; desirable but not required.

• Comprehensive understanding of the drug development process, including navigating COA development with regulatory bodies and creating evidence to support medical product labeling claims.

• Ability to lead multidisciplinary project teams across multiple simultaneous engagements while ensuring scientific quality, adherence to timelines, and effective decision-making.

• Strong analytical and writing skills.

• Excellent client-facing communication abilities and a capacity to lead discussions with senior stakeholders.

• Proven business development skills, including proposal scoping, budgeting, and contributing to sales and revenue enhancement.

🏝️ Benefits

• Competitive salary plus bonus scheme.

• Options for medical, dental, and vision insurance.

• 401(k) plan with employer matching.

• Flexible paid time off program along with 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 at 1.5 times annual salary.

• Paid parental leave.