Accomplished Assistant Director combines cross-functional competencies in operations planning, customer retention and financial management to develop and coach staff while interfacing with executives. Expert in boosting revenue, quality and performance. Successful in executing standard operating procedures to positively impact organizational goals.
Open To Work
Hi, I’m
Isabel Brown
Summary
Overview
4
years of professional experience
Work History
Merck & Co.
Associate Director of Clinical Operations, Diversity Program Lead
10.2024 - Current
Job overview
- Primary lead to develop, coordinate, and oversee the operational strategy, planning implementation and evaluation of global patient diversity for assigned therapeutic areas.
- Collaborates with multiple cross functional stakeholders to author, develop, and implement the diversity action plan and monitor the deliverables to drive diverse enrollment.
- Aligns with the clinical trial team to define diversity enrollment goals and implement targeted approaches with regular oversight to provide progress and feedback to trigger additional actions where needed to ensure the representation of populations impacted by the disease evaluated are enrolled in the trial.
- Strong knowledge in clinical trial operations and execution, deep understanding of the barriers to diverse participant enrollment and develop initiatives to overcome and build standards, best practices in community outreach / diverse participant engagement.
- Responsible owner of relevant process and training document(s) associated with Diversity and Inclusion in Clinical Trials (DICT).
- Accountable for DICT deliverables with oversight throughout clinical trial program.
- Partners externally/internally to define key initiatives related to DICT.
- Develops subject matter expertise in DICT to represent the business both internally/externally.
Genentech
Associate Clinical Trial Leader, gRED Early Clinical Development
06.2023 - 10.2024
Job overview
- Served as a member of multiple global cross-functional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out).
- Created a positive work environment by encouraging mutual respect, instills innovation and accountability on a functional and project level, both locally and globally to implement and deliver the study.
- Participated in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as vendor specifications, drug supply forecasting, monitoring and communication plans.
- Created trial master files (TMF) and ensures quality and completeness of TMF and quality of data in systems including CTMS.
- Collaborated with team members including the PET members to solicit input to deliver on study goals.
- Participates in selection of vendors and oversees outsourced activities to ensure CRO and vendors deliver against contracted scope of work.
- Contributed to the identification, assessment and selection of countries and sites, in partnership with study teams and CRO.
- Skilled at supporting logistics for the study team (e.g., managing and tracking payments, clinical supplies, supporting investigator and vendor meetings, iHCP approval, insurance certificates).
- Demonstrated a patient and site-centric mindset in all interactions and through the implementation of study activities.
- Partnered with colleagues to develop process improvements and establish best practices to enhance clinical trials across the organization.
- Served as Subject Matter Expert for Inclusive Research and Health Equity.
Genentech
Inclusive Research and Health Equity, Clinical Operations
06.2022 - 06.2023
Job overview
- Led and managed teams with creation of central inclusive research and health equity strategy for Genentech's early phase portfolio.
- Main point of contact for study teams on inclusive research tactics; such as incorporating D&I questions into site feasibility, providing population analysis based on indication, and designing patient-focused documents (informed consent forms, educational brochures, etc.).
- Conducted interviews with early clinical development study teams to learn of tactics and burdens related to inclusive research, and use subsequent data to design plan to implement inclusive research into everyday practices.
- Delivered presentations to internal and external forums on various topics in Inclusive Research and Health Equity, such as, healthcare provider and patient education, LGBTQ+ health equity, social determinants of health/demographic data, community engagement, and CRO training.
- Built and maintained central repository of inclusive research resources.
- Developed operational key performance indicators to measure adoption of health equity tactics across study teams.
- Compiled prevalence and outcome data by race/ethnicity of diseases in Genentech's portfolio, enabling study teams to create enrollment goals for trials and track enrollment with real-time data.
- Coordinated the IRHE team quarterly summits, including logistics, agendas, and scheduling, resulting in successful summits on topics such as patient support, etc., with average attendance of 100+ employees.
- Advanced LGBTQ+ Health Initiatives by authoring guidance for collection of Sexual Orientation and Gender Identity (SOGI) data in clinical trials and presenting this to stakeholders, resulting in Genentech becoming the first known biotechnology company to collect SOGI data in clinical trials.
- Site liaison for Advancing Inclusive Research Site Alliance, managing portfolio sharing, study feasibility, contracting, and budgeting with diverse oncology and ophthalmology sites.
Education
New York UniversityNew York, NY
Bachelor of Science from Chemistry, Science and Society
05.2021
University Overview
- Presidential Honor Scholar
- Elevate Education President, 2021
Skills
- Clinical trial management
- Patient diversity strategy
- Regulatory compliance
- Data analysis
- Community engagement
- Cross-functional collaboration
- Project coordination
- Effective communication
- Team leadership
- Problem solving
- Stakeholder engagement
- Strategic planning
Pronouns
Pronouns
she/her/hersExternal Presentations
External Presentations
- 2025, Society For Clinical Research Site's Include Summit, Inclusivity Forum: LGBTQ+ Populations in Clinical Trials
- 2024, Society For Clinical Research Site's Include Summit, Inclusivity Forum: SGM Populations in Clinical Trials
- Society For Clinical Research Site's Oncology Summit, Balanced Complexity: Enhance Site and Patient Focus in Oncology Clinical Trials
- Center for Healthcare Innovation's Diversity, Inclusion, & Health Equity Symposium, The Future of Health Equity: Priorities of the Next Generation of Healthcare Leaders Panel
Awards And Key Contributions
Awards And Key Contributions
- 2024, Advancing Inclusive Research and Health Equity Influencer
- 2024, Advancing Inclusive Research and Health Equity Innovator
- 2023, Customer Engagement External Impact Award
Work Preference
Job Search Status
Open to workWork Type
Full TimeLocation Preference
On-SiteHybridSalary Range
$120000/yr - $200000/yrTimeline
Associate Director of Clinical Operations, Diversity Program Lead
Merck & Co.
10.2024 - Current
Associate Clinical Trial Leader, gRED Early Clinical Development
Genentech
06.2023 - 10.2024
Inclusive Research and Health Equity, Clinical Operations
Genentech
06.2022 - 06.2023
New York University
Bachelor of Science from Chemistry, Science and Society