Early drug development strategy & execution
Senior clinical development and operational leadership – without full-time infrastructure.
Clinical Insight. Strategic Direction. Operational Leadership.
Providing strategic advisory, fractional COO leadership, operational consulting, and execution support for emerging biotechs and specialty pharmaceutical companies from drug development to regulatory submission.
25+years in pharma and biotech
IND to NDA/BLAtrial execution to submission readiness
$20M+business impact
Sponsor + CROperspective
Focused support at critical development and operating inflection points.
Designed for emerging biotechs and specialty pharma teams preparing, launching, recovering or scaling clinical programs – and needing senior-level judgment to align development strategy, study execution, vendors, governance, risk and financial discipline.
01
Clinical Development Strategy
Convert an investor presentation into an operating and development plan, protocol development, optimal study design, endpoint definition & protection, country/site feasibility, ideal site profile and regulatory-readiness pathways.
02
CRO & Vendor Strategy
Lead CRO/FSP selection process, RFPs, bid evaluation, operating expectation, master service agreement/contract strategy, change control practices and onboarding.
03
Governance, Oversight & Risk
Governance charters, RACI models, Key Performance Indicators, Quality Tolerance Limits, risk management, escalation pathways and executive dashboards.
04
Fractional COO & Clinical Development Leadership
Embedded executive leadership that connects clinical-development strategy with business and operational execution. Alicia brings both Sponsor and CRO perspectives to align program priorities, performance and resource optimization, and risks – then builds the operating structure needed to advance milestones and protect enterprise value.
05
Portfolio & Financial Discipline
Decision-ready timelines, forecasts, scenarios, risk assessments, and recommendations for dashboards that give executives and boards clear portfolio and financial visibility.
06
Program Assessment & Recovery
Independent assessment of delayed or at-risk programs, root-cause analysis, recovery options and prioritized action plans.
Ideal fit for emerging biotechs & specialty pharma teams.
Engage senior clinical development and operational expertise when your organization needs direction – before building a permanent function or leadership transition.
Also, partnering with VC firms and boards seeking independent clinical insight or leadership support for portfolio companies.
Moderate to Severe Psoriasis
Rheumatoid Arthritis
Primary Immunodeficiency
Alpha-1 Antitrypsin Deficiency
Sickle Cell Disease
ROSAH Syndrome
Cell Esophageal Impact (CEI)
Cystic Fibrosis
Anti-Hemostasis Agent
Diabetes Type 1 & 2 (Adult & Peds)
Infectious Diseases
Amyloidosis
Presbyopia
Flexible engagement models.
Senior expertise structured around the scope, urgency and maturity of your development program.
Needing project MANAGEMENT or CONSULT short-term support
Requiring fractional COO or clinical leadership
ADVANCED CLINICAL DEVELOPMENT pLANNING
Moving toward regulatory submission readinESS
Strategy translated into accountable execution.
Alicia Weakley brings more than 25 years of pharmaceutical and biotechnology experience, including nearly a decade advising and leading programs for emerging and growth-stage biotechs. Unlike a generalist fractional operations lead, she combines hands-on clinical-development and global trial expertise with executive-level portfolio, financial and business-performance leadership.
Alicia is known not only for developing strategies, but for building the governance, accountability and operating discipline required to execute them.
She brings the judgment of an executive advisor, the financial discipline of a business leader and the hands-on mindset of an experienced clinical operator.
Need clinical development or operating leadership now?
Connect to discuss advisory, project-based, short-term, or fractional support for an upcoming development milestone, leadership gap, portfolio priority or at-risk program.
