Anne Rollins
Concord,CA
Summary
- Seasoned clinical development professional with over 23 years of clinical research experience.
- Expert knowledge of all relevant guidelines, including ICH, GCP, FDA, as well as those defined by international regulatory bodies.
- Direct involvement in indication planning, IND filing, CSR, and NDA submissions.
- Strong interpersonal, analytical and organizational skills, and demonstrated success in project and portfolio prioritization and management.
- Thorough understanding of cross-functional processes involved in study design and execution.
- Experience in Phase I FIH to Phase IV, large global, head-to-head, and post marketing requirement trials.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Senior Director, Clinical Operations
Janux Therapeutics Inc.
San Diego, CA
09.2022 - Current
- Responsible and accountable for planning and executing Phase I Clinical Projects: oversight and directional alignment of timelines, budget, and key deliverables, as well as contributing to overall clinical strategy.
- Responsible for overseeing all clinical start-up activities, including IND regulatory preparation, feasibility, country selection, team resourcing, supply chain, budget and timeline planning.
- Responsible for Clinical Operations functional and project budget, forecasting, long-range planning, quarterly reporting with Finance, and Project Management.
- Responsible for global outsourcing strategy, including strategic partnerships with CROs, vendors, investigators, and other external partners.
- Identify and build relationships with KOLs for protocol development activities.
- Develops, analyzes, and reports performance metrics for clinical programs. Sets operational performance goals, key performance indicators, and targets.
- Identify and drive process improvement initiatives in collaboration with cross-functional leaders within the organization, including SOP development.
- Functional leadership and direct line management, including mentoring, training, performance evaluation, and career development.
Director, Clinical Operations
Nuvation Bio, Inc.
San Francisco, CA
04.2021 - 08.2022
- Lead strategic planning and activities related to program development, including indication planning, IND filing, study start-up, operations, execution, risk identification and remediation, and reporting.
- Work closely with regulatory and medical writing to plan and execute IND filing and study protocols.
- Partner effectively with cross-functional groups such as data management, pharmacovigilance, CMC, biostatistics, medical writing, quality assurance, regulatory and medical affairs.
- Drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders, including but not limited to the Executive Team, Principal Investigators, KOLs, CRO partners, and Steering Committee members.
- Develop understanding of key competitive intelligence sources and provide updates to program development stakeholders.
- Identify and drive process improvement initiatives in collaboration with cross-functional leaders within the organization, including SOP development.
- Facilitate an innovative, collaborative, and motivational team culture. Coach and mentor direct and indirect reports with succession planning in mind.
Director, Clinical Operations
Adamas Pharmaceuticals, Inc.
Emeryville, CA
01.2019 - 04.2021
- Lead clinical programs that include proof of concept and two pivotal Phase III studies.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems, statistical analysis plans, and clinical study reports.
- Oversee development and management of clinical development plans, including timelines, budget, and resource requirements.
- Ensure development and implementation of clinical program strategy.
- Direct programs to meet company goals and objectives.
- Direct and coordinate outsourcing activities across programs.
- Direct program advisory committees and expert consultants, as needed.
- Drive project risk analysis to implement mitigations and develop solutions to complex problems.
- Identify program gaps and implement solutions by creating processes and standard operating procedures.
- Supervise and mentor direct reports.
Associate Director, Clinical Operations
Myovant Sciences, Inc.
Brisbane, CA
01.2017 - 08.2018
- Oversee program of pivotal global studies (214 sites in 22 countries).
- Coordinate and lead protocol development and authoring activities.
- Plan and manage validation activities for primary and secondary endpoint assessments.
- Oversee study start-up activities, including vendor selection, budget negotiation, and system design.
- Develop program-related process documents and facilitate planning for NDA/EMA submissions.
- Participate in briefing book preparation for FDA meetings.
- Facilitate timely response to questions from regulatory authorities regarding submissions or FDA feedback.
- Develop and implement clinical trial management strategies and SOPs to ensure data integrity, quality, and results within budget constraints.
- Participate in financial forecasts, accruals, and invoice processing.
- Collaborate with cross-functional teams to ensure that study project milestones are on track, proactively identify risks, lead the team to strategize solutions, and implement mitigation plans to eliminate or reduce impact.
- Influence senior management and teams to balance decisions that impact quality and timelines.
- Communicate 'big picture' implications and considerations of drug development strategies to cross-functional stakeholders.
- Define inspection processes, lead planning and implementation of inspection readiness procedures.
- Initiate efforts to ensure study management learnings are applied across studies and programs.
- Keep abreast of changes within the industry to introduce new techniques and alternative methodologies to clinical teams.
- Hire, manage, and mentor direct and indirect reports.
Clinical Project Manager
Medivation, Inc.
San Francisco, CA
09.2014 - 01.2017
- Manage clinical outsourcing to CROs and study vendors.
- Oversee development, review, and approval of various study-related documents and plans.
- Provide oversight and management of study timelines and budget.
- Review and approve vendor agreements, change orders, and invoices.
- Identify project risks and implement mitigations.
- Escalation point for study-related issues.
- Drive planning and conduct of Investigator Meetings.
- Assist with completion of clinical study reports.
- Lead internal and external cross-functional teams through 'change of sponsorship' activities.
- Assess, prioritize, and implement rescue and risk mitigation activities for acquired talazoparib studies.
- Assist with transition tasks related to company acquisition (Pfizer).
- Supervise and mentor direct reports.
Senior Clinical Site Manager
IQVIA Biotech
California
03.2008 - 08.2014
- Responsible for conducting and managing Amgen clinical studies, including study planning and implementation for site monitoring and data quality.
- Conduct feasibility assessments for new studies.
- Evaluate quality and integrity of study site practices and adherence to applicable regulations.
- Create study tools, documents, and processes.
- Contribute to vendor oversight activities.
- Project Team Lead for trials assigned to risk-based monitoring model, early development specialist, Oncology Training Facilitator.
Clinical Research Associate
ChemoCentryx, Inc.
Mountain View, CA
09.2007 - 03.2008
- Participate in selection of vendors, including a Phase I facility.
- Manage vendors and CROs for global Phase I/II trials.
- Organize and participate in KOL and Steering Committee meetings.
- Perform in-person visits with Principal Investigators in EU and AU to provide education about the therapeutic landscape and investigational product.
- Author SOPs and various documents for development of Clinical Operations Department.
- Initiated study vendor selection and implementation activities for upcoming Phase III study.
Clinical Research Associate
AstraZeneca Pharmaceuticals
San Francisco, CA
10.2004 - 09.2007
Clinical Research Assistant
Scios, Inc.
Fremont, CA
06.2004 - 10.2004
Clinical Study Coordinator
University Of California, San Francisco
San Francisco, CA
09.2001 - 05.2004
Education
Bachelor of Arts - Community Studies: Focus in Public Health
University Of California, Santa Cruz
Santa Cruz, CASkills
- Team management
- Collaborative leadership
- Strategic planning
- Process improvement
- Issues resolution
- Risk management
- Project management
Certification
ACRP, Certified Clinical Research Associate
IQVIA Global Mentor of the Year, 2013
Therapeutic Experience
Janux Therapeutics Inc.
Phase 1 Oncology (Advanced Solid Tumors)
Phase 1 Autoimmune
Nuvation Bio, Inc
Phase 1 Oncology (Advanced Solid Tumors)
Adamas Pharmaceuticals, Inc.
Phase III Multiple Sclerosis, Parkinson's Disease
Myovant Sciences, Inc.
Phase III Endometriosis- Associated Pain
Medivation, Inc.
Phase I-IV Oncology (Prostate, Breast, DLBCL, Diffuse Intrinsic Pontine Glioma)
IQVIA / Amgen
Phase I–IV Oncology/Hematology (SCLC, NSCLC, Pancreatic, Breast, Ovarian, Ewing’s Sarcoma, DRCT, Head and Neck, Prostate, Soft Tissue Sarcoma, Gastric and Esophageal, Giant Cell Tumor, ALL, AML, CML, CLL)
Phase I Systemic Lupus Erythematosus
Phase III Myelodysplastic Syndrome, Idiopathic Thrombocytopenic Purpura
Phase IV End Stage Renal Disease
ChemoCentryx, Inc.
Phase 1 CNS
Phase II Crohn’s Disease, Celiac Disease
AstraZeneca Pharmaceuticals
Phase II-III Oncology (NSCLC, Breast, Prostate, Thyroid)
Phase II-III Cardiology (Type II Diabetes, Hyperlipidemia, Acute Coronary Syndrome, and Congestive Heart Failure)
Phase III CNS (Schizophrenia, Bi-polar Disorder)
Scios, Inc.
Phase II-III Cardiology (Congestive Heart Failure)
University of California, San Francisco
HIV/AIDS early infection trial for pathology, immunology, virology
HIV/AIDS serodiscordant couples and cross-infection
HIV/AIDS positive couples / cross-infection of resistant strains
HIV/AIDS treatment interruption therapies and IL-2
Phase 1 HIV vaccine trials
Timeline
Senior Director, Clinical Operations
Janux Therapeutics Inc.
09.2022 - Current
Director, Clinical Operations
Nuvation Bio, Inc.
04.2021 - 08.2022
Director, Clinical Operations
Adamas Pharmaceuticals, Inc.
01.2019 - 04.2021
Associate Director, Clinical Operations
Myovant Sciences, Inc.
01.2017 - 08.2018
Clinical Project Manager
Medivation, Inc.
09.2014 - 01.2017
Senior Clinical Site Manager
IQVIA Biotech
03.2008 - 08.2014
Clinical Research Associate
ChemoCentryx, Inc.
09.2007 - 03.2008
Clinical Research Associate
AstraZeneca Pharmaceuticals
10.2004 - 09.2007
Clinical Research Assistant
Scios, Inc.
06.2004 - 10.2004
Clinical Study Coordinator
University Of California, San Francisco
09.2001 - 05.2004
Bachelor of Arts - Community Studies: Focus in Public Health
University Of California, Santa Cruz