Alicia B Savage
Rowley
Summary
Accomplished professional with over 25 years of experience in drug development across small biotech start-ups, mid-sized firms, and large global pharmaceutical companies in the Cambridge and Boston, MA area. Expertise across global clinical operations, program management, and data management, with more than a decade of on-site global monitoring and extensive project oversight in pivotal clinical trials across various indications, including oncology, neuroscience, and orphan drug diseases. Proven track record in end-to-end delivery of clinical operations—from initial strategy and trial execution to regulatory submissions and drug approvals—while fostering strong collaborations with CROs, alliance partners, and inspection readiness across regulatory bodies such as the FDA, MHRA, EMA and PMDA. Results-driven leader committed to enhancing patient care and operational efficiency through strategic planning and team leadership.
Overview
26
26
years of professional experience
Work History
Senior Global Clinical Program Director
AstraZeneca Pharmaceuticals-Late Oncology Development
Waltham, MA
03.2014 - Current
- Oncology: Phase III AZD2265 (FPI-2265) Radioconjucates Program (Prostate)
- Managed clinical operations, leading global product team in the execution and oversight of Phase 3 registrational trials.
- Crafted comprehensive strategy for project execution and success in clinical development of new oncology asset (radioconjugate) Phase III global trials
- Coordinated efforts to support seamless integration of newly acquired drug asset from Fusion to AstraZeneca (AZD2265, FPI-2265). Phase III readiness, integration of team members
- Provide expert input on clinical project strategy, clinical development plans, protocol design, execution & budgets.
- Oversaw budget management for clinical projects, ensuring resource allocation aligned with program priorities.
- Established partnerships with external stakeholders to facilitate collaboration on innovative research initiatives.
- Presented program updates to senior leadership, driving informed decision-making through data-driven insights.
- Mentored junior staff members, fostering professional growth and contributing to a positive work environment that supports collaboration and innovation.
Senior Global Clinical Program Director
AstraZeneca
Waltham, MA
03.2014 - Current
- Oncology: Phase III (datopotamab deruxtecan) ADC DATROWAY Program (Breast, Lung, PanTumor, Bladder)
- Oncology: Phase III AZD5335 (TREVI) ADC (Ovarian)
- Clinical operations lead for global product team (GPT) drug programs, focusing on the execution and delivery of the global Phase 3 registration trials.
- Crafted strategic framework for the clinical operations and project execution for (datopotamab deruxtecan) DATROWAY in partnership with an alliance partner for AZ executed clinical trials
- Collaborated with internal stakeholders to design and implement development plans for 20 new Phase III clinical trials addressing breast, lung, pan tumor and bladder indications over a 3–5-year period through internal and alliance partner governance
- Directed the planning and implementation of five key registration Phase III studies for Breast portfolio, focusing on successful outcomes between 2021 and 2025.
- Managed comprehensive inspection readiness initiatives and oversight to facilitate inspections for initial NME submission and approval. Successful participation in 20+ site vendor and various country regulatory agencies
- EMA, PMDA regulatory agency inspections and FDA review cycle interactions.
- Mentoring junior staff within clinical operations, project management
Global Clinical Program Director
AstraZeneca Pharmaceuticals
Cambridge, MA
03.2014 - Current
- Oncology: Phase I/II Product Level Global Product Team (GPT) Global Clinical Operations Lead across 5 programs
- Creation of initial Strategy, ensuring optimal execution, delivery, internal governance endorsement, presentations
- Developed strategic plans for clinical program objectives, budget and timelines.
- Analyzed clinical data to guide decision-making and improve outcomes.
- Collaborated with external partners to enhance program efficiency and effectiveness.
Clinical Operations Program Director
AstraZeneca Pharmaceuticals-Neuroscience IMED
Cambridge, MA
03.2014 - Current
- Neuroscience: Phase I/II AZD3241 (MPOi) Multiple System Atrophy (MSA)
- Program strategy, clinical development plans, protocol design, execution & budgets.
- Directed cross-functional teams to align strategic objectives with operational capabilities.
- Developed and implemented process improvements to enhance operational efficiency and reduce costs.
Director of Clinical Operations
Zalicus, Inc.(formerly Combinatorx)
Cambridge, MA
04.2013 - 03.2014
- Neuroscience/Neuropathic Pain: Phase I,II Z160(N-type CC blocker) & Z944 (T-type CC blocker) Programs
- Managed cross-functional teams to ensure compliance with regulatory standards and protocols.
- Oversaw budget allocation for clinical trials, ensuring optimal resource utilization.
- Collaborated with external partners to streamline clinical trial processes and enhance study execution..
- Mentored junior staff members, contributing to the development of a high-performing, cohesive team focused on achieving departmental goals.
Associate Director, Clinical Operations
Infinity Pharmaceuticals, Inc.
Cambridge, MA
05.2009 - 02.2012
- Oncology: Phase I/IIb
- IPI-504 (HSP90) NSCLC, IPI-926 (Hedgehog pathway) advanced or metastatic solid tumors
- Led cross-functional teams, project timelines, ensuring alignment with regulatory requirements and corporate objectives.
- Mentored junior staff, fostering professional growth and enhancing team capabilities.
Senior Project Manager, Clinical Operations
Infinity Pharmaceuticals, Inc.
Cambridge, MA
03.2008 - 05.2009
- Oncology: Phase I/IIb
- Developed and implemented project and led cross-functional teams to deliver complex projects on time and within budget.
Senior Manager Clinical Monitoring
Sepracor, Inc(Sunovion)
Marlborough, Massachusetts
07.2007 - 03.2008
- Neuroscience: Phase I/II/III PET Imaging & global pivotal MDD trial
- Led cross-functional teams to achieve project milestones and deliver high-quality results.
Manager of Clinical Operations
Combinatorx, Inc.(Zalicus Inc.)
Cambridge, Massachusetts
01.2005 - 06.2007
- Oncology: Phase I/II, Phase II Psoriasis, Phase I/II Asthma, Phase II RA & OA
- Responsible for line management for a team of 10 (CRCs, CRAs, Consultants)
Senior Clinical Research Associate (CRA)
Boston Scientific Corporation
Natick, MA
06.2004 - 01.2005
- Sr.CRA/Lead CRA IDE study for esophageal stent for malignant oncology strictures/tumors
Lead Clinical Research Associate (CRA)
Transkaryotic Therapies Inc. (TKT, SHIRE)
Cambridge, MA
05.2002 - 06.2004
Primary/Lead Clinical Data Manager
Parexel International
Waltham, Massachusetts
05.2000 - 2002
Education
Bachelor of Science - Health Management and Health Policy
University of New Hampshire
Durham, New HampshireSkills
- Therapeutic area expertise
- Patient recruitment
- Clinical data management
- Cross functional leadership
- Program management
- Protocol development
- Product lifecycle management
- Staff mentoring
- Clinical operations oversight
- Clinical strategy development
- Teamwork and collaboration
Section name
Connective Tissue Oncology Society (CTOS), American Society Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO), Multiple System Atrophy (MSA) workshop and conference, attendance at multiple patient advocacy group meetings across indications.
Timeline
Senior Global Clinical Program Director
AstraZeneca Pharmaceuticals-Late Oncology Development
03.2014 - Current
Senior Global Clinical Program Director
AstraZeneca
03.2014 - Current
Global Clinical Program Director
AstraZeneca Pharmaceuticals
03.2014 - Current
Clinical Operations Program Director
AstraZeneca Pharmaceuticals-Neuroscience IMED
03.2014 - Current
Director of Clinical Operations
Zalicus, Inc.(formerly Combinatorx)
04.2013 - 03.2014
Associate Director, Clinical Operations
Infinity Pharmaceuticals, Inc.
05.2009 - 02.2012
Senior Project Manager, Clinical Operations
Infinity Pharmaceuticals, Inc.
03.2008 - 05.2009
Senior Manager Clinical Monitoring
Sepracor, Inc(Sunovion)
07.2007 - 03.2008
Manager of Clinical Operations
Combinatorx, Inc.(Zalicus Inc.)
01.2005 - 06.2007
Senior Clinical Research Associate (CRA)
Boston Scientific Corporation
06.2004 - 01.2005
Lead Clinical Research Associate (CRA)
Transkaryotic Therapies Inc. (TKT, SHIRE)
05.2002 - 06.2004
Primary/Lead Clinical Data Manager
Parexel International
05.2000 - 2002
Bachelor of Science - Health Management and Health Policy
University of New Hampshire