Senior Program Manager

Calico Life Sciences

South San Francisco, California

2021 – Current

• Recipient of a “Key Contributor Award” in first year at Calico, awarded to the top 10% of contributors across Calico.

• Led and methodically designed protocols and SOPs for programs across the various stages of the pre-clinical/clinical development pipeline.

• Led and managed teams from pre-IND through Phase II, acquiring extensive experience in leading and managing global project teams and their successful filing of INDs, CTAs, IDEs for companion diagnostics.

• Managed large-scale, global studies and programs at various external contract research organizations, requiring virtual and on-site visits and extensive external stakeholder management planning.

• Conducted quarterly and annual resource and budget presentations, reviews, and forecasts for stakeholders up to senior leadership.

• Analyzed historical data to perform resource gap analyses and forecasts, asset utilization, and validated proposals to align with overall corporate strategy.

• Managed not only technical and schedule performance, but also cost performance, planned value, budgeted cost of work, and earned value.

• Applied an adeptness for statistical modeling, data mining, and predictive analytics, and developed work breakdown structures and performance measurement baselines for better powered analyses.

• Guided and managed seasoned drug developers to provide strategic leadership for programs in Lead Optimization through clinical Proof of Concept.

• Helped to implement, grow, and user-test Smartsheet, Asana, and other PM infrastructural tools as internal timeline/task tracking resources.

• Cross-functionally connected teams including R&D, clinical development, operations, technology, manufacturing, business development, regulatory/legal, and the AbbVie-Alphabet partnership to drive alignment on common goals.

• Tracked study timelines and action items in technology-led projects with Google vendor security, compliance, and external stakeholders.

• Led GxP oversight activities as a Vendor Owner and initiated process changes on how Calico identifies and classifies development risks alongside AbbVie and their subcontractors, specifically for audits and submissions to international regulatory bodies.

• Hired and onboarded project management staff to expand clinical and preclinical PM and operational capabilities.

Project Manager

TENAYA THERAPEUTICS

SOUTH SAN FRANCISCO, CALIFORNIA

2018 – 2021

• Operated as a project manager to drive vascular and endovascular technologies, heart failure devices, and pharmaceutical assets towards clinical development.

• Coordinated over $2MM of externally conducted large-scale studies and presented results and updates to senior level executives.

• Led and creatively designed numerous drug discovery and pharmacology projects designed to enhance target coverage by route of administration or capsid engineering, improve clinical prognostication through biomarker discovery, and ultimately elucidate the mechanisms underlying heart failure.

• Collaborated with Regulatory and Legal to compile data packages and reports for FDA INTERACT meetings and IND, CTA, and IDE applications.

• Independently piloted studies from early discovery, experimental optimization, PoC, efficacy and safety pharmacology, through indication expansion, culminating in formal data analysis and presentation.

• Established numerous forms of automation platforms to increase study bandwidth and efficiency, reduce ambiguity, and better facilitate the management of outsourced projects at contract research organizations.

Scientific Researcher

Genentech

SOUTH SAN FRANCISCO, CALIFORNIA

2018

• Conducted research using patient derived xenografts (PDX) to characterize various forms of breast cancer and their pathophysiology.

• Utilized numerous approaches to design PDX studies to assess PK/PD profiles, biomarker changes, safety pharmacological, and efficacy.

• Authored and managed various protocols and SOPs for studies conducted both internally and externally.

• Independently conducted research on the pre-Bötzinger complex and a subset of neurons responsible for generating the respiratory pacemaker.

• Automated the identification of specific pathophysiological signatures in xplethysmography recordings for more high-throughput, timely data analysis turnaround time.

• Trained new personnel in generation and submission of research and safety protocols, order fulfillment and procurement, as well as the establishment and optimization of novel research techniques.

• Managed the UCSF Brain Bank inventory – a repository for human nervous system tissue donated for research purposes.