Early drug development strategy & execution
Senior clinical operations leadership-without full-time infrastructure.
Clinical Insight. Strategic Direction. Operational Results.
Providing advisory, operational consulting, hands-on execution support and fractional leadership to biotechs and small-to-mid pharmaceutical companies from drug development to regulatory submission.
25+years in pharma & biotech
$20M+revenue acceleration impact
IND/BLAtrial execution to submission readiness
Alicia Weakley, MBA
Clinical Strategy & Operations Consultant | Pharma & Biotech
Focused support where early-stage teams need it most.
Designed for biotechs preparing, launching, recovering, or scaling clinical programs where senior-level operational judgment is needed quickly.
01
Clinical Development Strategy
Operationalize clinical plans, protocol intent, endpoint protection, feasibility, country/site strategy and regulatory-readiness pathways.
02
CRO & Vendor Oversight
Support CRO/FSP selection, RFPs, bid defense preparation, governance design, KPI models, performance recovery and contract alignment.
03
Execution & Risk Recovery
Resolve threats to timelines, enrollment, data quality, endpoint integrity, sponsor confidence, budget adherence and cross-functional delivery.
04
Portfolio & Financial Discipline
Improve forecasting, resource optimization, utilization review, change-order strategy, dashboards, portfolio visibility and executive decision support.
Ideal fit for lean biotech teams.
Engage senior clinical operations expertise when the company needs direction, discipline and hands-on execution – before building a larger permanent function.
- Rare Disease
- Orphan Drug
- Autoimmune
- Early-phase
- Complex pivotal global trials
Flexible engagement models.
Senior expertise structured around the scope, urgency and maturity of your program. Use only the level of support you need—from strategic advisory to hands-on execution leadership.
Project-Based Advisory
Defined deliverables such as vendor selection, study rescue, governance setup, RFP support, inspection readiness, or operating model design.
Short-Term Consulting
Focused support during launch, recovery, transition, funding, submission-readiness or resourcing gaps.
Fractional Leadership
Embedded senior clinical operations leadership for growing teams that need executive-level oversight before a full-time hire.
Strategy translated into accountable execution.
Alicia Weakley brings 25+ years across Sponsor and CRO environments, with leadership across global clinical programs and multiple TA, CRO oversight, portfolio governance, operational transformation, contract execution and negotiation, budget development, regulatory submission support and global clinical trial delivery (North America, South America, West and East Europe, Sub-Saharan Africa, Middle East and Asia-Pacific regions). The focus is practical: clarify the strategy, build the operating path, and deliver measurable results.
Insight + executionSenior-level advisory paired with hands-on operational leadership for teams moving from development concept to clinical execution and regulatory submission readiness.
Need clinical operations leadership now?
Connect to discuss project-based, short-term, or fractional support for your development program.