ANNE S. CLARK
Newton,MA
Summary
Clinical professional with proven record of managing clinical research protocols to successful completion. Advanced knowledge in oncology protocols complemented by collaborative approach to team management. Reliable in adapting to dynamic healthcare environments and dedicated to achieving optimal results through strategic planning and execution.
Overview
26
26
years of professional experience
Work History
Senior Clinical Manager (Lung, PDAC and Cholangiocarcinoma)
Merus, NV
11.2021 - Current
- Operationalized Phase II oncology clinical study through to FDA approval.
- Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
- Ensured compliance with regulatory guidelines and accreditation standards through consistent monitoring and implementation of corrective actions when needed.
- Successfully completed 2 week in person FDA inspection.
- Prepared sites for inspection by FDA – no 483s issued.
- Prepared story boards, updated project plans, essential documents and TMF to support BLA submission.
- Responsible for ongoing data review and query resolution, vendor management for the asset.
Clinical Study Lead (contract) (Pain)
Regeneron Pharmaceuticals, Inc.
11.2020 - 10.2021
- Lead cross-functional study team responsible for study delivery and oversight for assigned studies
- Oversee and provide input to the development of study specific documentation, including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, data review plan, statistical analysis plan, etc.
- Ensure the global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines and SOPs in the required standard of quality.
- Prepared the team for inspection readiness and submission to FDA/EMA.
- Self-motivated, with a strong sense of personal responsibility.
- Skilled at working independently and collaboratively in a team environment.
Global Senior Clinical Project Manager (contract) (Lung Cancer)
Ipsen Inc., Cambridge MA
04.2019 - 10.2020
- Led cross-functional teams to successfully complete complex clinical trials within budget and deadline constraints.
- Managed vendor relationships and negotiated contracts, ensuring timely delivery of high-quality services while maintaining cost control.
- Ensured compliance with regulatory requirements by conducting regular audits and implementing corrective actions as needed.
- Collaborated with marketing teams to develop communication materials for key stakeholders, ensuring accurate representation of study results and their implications for patient care.
Senior Clinical Project Manager, Clinical Development (Lung and PDAC)
Karyopharm Therapeutics Inc., Newton, MA
03.2018 - 04.2019
- Responsible for the planning, implementation, execution, and management of Phase I/II oncology studies.
- Manage clinical outsourcing to CROs and other vendors such as labs, IRBs, etc.
- Mentored junior staff members in clinical project management best practices, fostering a culture of continuous learning and professional development.
- Evaluate issues, interpret data, and suggest and implement solutions and risk mitigation as required.
- Responsible for the financial management of a study/program and develops and oversees study timelines.
Senior Clinical Trial Manager, Global Clinical Development (Ovarian and SCLC)
TESARO, Inc., Waltham, MA
03.2017 - 03.2018
- Lead clinical phase I/II oncology studies in alignment with the company’s strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice.
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
Project Manager, Clinical Development (Cardiology)
New England Research Institutes, Inc., Watertown, MA
11.2015 - 02.2017
- Plan and execute operational aspects of research projects in alignment with strategic and regulatory goals.
- Develop and monitor project timelines and budgets.
- Assign project staff resources and oversee completion of tasks.
- Responsible for coordinating, planning, and overseeing DSMB and CEC meetings.
- Responsible for creation of safety narratives.
- Interface with study sponsors, contractors, and vendors.
- Provide oversight of periodic reporting to regulatory agencies and sponsors.
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
Public Health Program Coordinator, Needham Public Health Department
Town of Needham, Needham, MA
01.2013 - 01.2015
- Created health education and training programs for the department.
- Steering Committee member responsible for evaluating grant applications and funding opportunities.
- Conducted health needs assessment to determine the top Metro West health needs.
- Researched and developed policies for youth concussion training, medical marijuana dispensaries, body art, and bodywork.
- Wrote bi-weekly articles on health-related topics for the Needham Times, Hometown Weekly, and the Patch.
- Secretary for the Needham DVAC- Domestic Violence Action Committee, responsible for meeting minutes, and creating educational programming.
Senior Trainer, Clinical Development
Glaxosmithkline Llc
01.2007 - 01.2013
- Designed and delivered training on standard operating procedures (SOPs), ICH/GCP, FDA/EMEA guidelines, safety and disease-related topics for clinical staff (in person and virtual).
- Trained clinical staff on clinical safety issues, clinical safety systems and regulatory requirements to ensure inspection readiness and successful operationalization of clinical trials.
- Organized programs on corrective action preventative action plans (CAPA), GCP and FDA updates, related to changes in regulatory matters, findings from audits, and therapeutic standards.
- Trained site and study personnel on protocol and site requirements for successful clinical trial enrollment.
- Worked with corporate compliance department to develop root cause analysis and corrective action plans to address clinical and corporate compliance issues.
Principal Clinical Research Scientist, Early-Stage Clinical Development- Infectious Disease
Glaxosmithkline Llc
01.2001 - 01.2007
- Operationalized Phase I & II clinical trials responsible for protocol writing, site and vendor management resulting in on-time delivery of clinical study results.
- Handled operational feasibility and input into protocol design and study execution.
- Selected and managed vendors and developed vendor specifications.
- Accelerated drug development timelines by prioritizing tasks and collaborating closely with cross-functional teams.
- Contributed to the design of novel therapeutic interventions, conducting extensive literature reviews and evaluating preclinical data.
- Audited study records for completeness and accuracy.
Clinical Research Scientist, Late-Stage Clinical Development- HIV franchise
Glaxosmithkline Llc
01.1999 - 01.2001
- Operationalized Phase III & IV clinical trials with responsibility for protocol writing, site and vendor selection.
- Developed investigator relationships and initiated sites across 40 locations in US, Dominican Republic, Guatemala, and Panama, enabling rapid recruitment of the study.
- Coordinated, planned and presented at investigator and coordinator training sessions on best practices and recruitment strategies.
- Performed investigational pre-study, initiation, and on-going site visits.
- Improved clinical trial efficiency by streamlining processes and implementing innovative study designs.
- Facilitated clear communication across study teams, ensuring timely updates on project progress and proactively addressing potential issues.
Education
Master of Public Health (M.P.H.) -
University of Michigan, School of Public Health
Ann Arbor, MI01.1996
Bachelor of Arts (B.A.) - undefined
Johns Hopkins University
Baltimore, MD01.1993
Skills
- CRO oversight
- Protocol Development
- Data review
- Inspection Readiness
- Story Boarding
- GCP compliance
Timeline
Senior Clinical Manager (Lung, PDAC and Cholangiocarcinoma)
Merus, NV
11.2021 - Current
Clinical Study Lead (contract) (Pain)
Regeneron Pharmaceuticals, Inc.
11.2020 - 10.2021
Global Senior Clinical Project Manager (contract) (Lung Cancer)
Ipsen Inc., Cambridge MA
04.2019 - 10.2020
Senior Clinical Project Manager, Clinical Development (Lung and PDAC)
Karyopharm Therapeutics Inc., Newton, MA
03.2018 - 04.2019
Senior Clinical Trial Manager, Global Clinical Development (Ovarian and SCLC)
TESARO, Inc., Waltham, MA
03.2017 - 03.2018
Project Manager, Clinical Development (Cardiology)
New England Research Institutes, Inc., Watertown, MA
11.2015 - 02.2017
Public Health Program Coordinator, Needham Public Health Department
Town of Needham, Needham, MA
01.2013 - 01.2015
Senior Trainer, Clinical Development
Glaxosmithkline Llc
01.2007 - 01.2013
Principal Clinical Research Scientist, Early-Stage Clinical Development- Infectious Disease
Glaxosmithkline Llc
01.2001 - 01.2007
Clinical Research Scientist, Late-Stage Clinical Development- HIV franchise
Glaxosmithkline Llc
01.1999 - 01.2001
Bachelor of Arts (B.A.) - undefined
Johns Hopkins University
Master of Public Health (M.P.H.) -
University of Michigan, School of Public Health
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