Summary
Overview
Work History
Education
Skills
Affiliations
Publications
Training
Timeline
Generic

Michael R. Myers

Cathedral City,CA

Summary

Knowledgeable Senior Clinical Operations Leader with proven background in leading operational teams to streamline processes and enhance efficiency. Successfully implemented initiatives that improved workflow and resource management. Demonstrated leadership and strategic thinking in driving team performance and operational excellence.

Overview

34
34
years of professional experience

Work History

Senior Clinical Operations Lead

Forte Biosciences, Inc
01.2025 - 09.2025
  • Leads global team directing Start-Up for Celiac Phase 2 program in Australia, New Zealand and the United Sates
  • Managing and directing relationships with key CRO strategic partners and vendors
  • Overseeing and sourcing the CRO for the study working directly with the senior leadership to guide them through the Start-Up period under very short and critical timelines Ensures compliance with Good Clinical Practices, Good Manufacturing Practices, and regulatory guidelines.
  • Recommends and implements innovative process ideas to impact clinical trials management.
  • Oversees development and management of clinical budget and the development of contingency plans for clinical trials.
  • Acts as a cross functional liaison to ensure study plan aligns with business development strategies.
  • Perform background research analysis and ongoing research analysis during the conduct of the clinical trials.
  • Oversees development of Case Report Forms, Informed Consent Forms, and IRB submission materials.
  • Evaluates clinical data, data quality, and other study information to assist in providing interim and final reports on projects.
  • Prepares research reports by confirming Case Report Form (CRF) and Severe Adverse Event (SAE) reporting, identifying protocol deviation, summarizing information, citing patient response, adhering to federal guidelines.
  • Collects information by searching and interviewing investigators and patients, comparing information discovered to information specifications, and preparing correspondence.

Sr. Director, Clinical Operations, Head of Clinical Vendor Management

Neumora Therapeutics
07.2020 - 06.2024
  • Leads global team supporting key functions (e.g., resource planning)
  • Manages relationships with key CRO strategic partners, vendors and their leadership teams
  • Contributes and supports the Finance department by establishing and delivering within annual project/program budgets
  • Supports Finance department by participating in BoD required quarterly, external audits
  • Contributes to and supports Legal to establish MSA’s, SoW’s, Consulting Agreements and CDA’s with necessary vendors, consultants, etc.
  • Participate in strategic relationship oversight, management, and issue resolution
  • Point of escalation for execution or quality issues related to conduct of studies by strategic partners or vendors
  • Leads Joint Operating Committees and Executive Steering Committees in partnership with relevant stakeholders
  • Identifies new business opportunities to collaborate with strategic partners
  • Monitors the health of the relationships including performance, financial and culture; takes appropriate actions
  • Establishes criteria to measure the overall health of Clinical Operations, trial delivery and vendor performance.
  • Identifies and drive the implementation of key information technology, business systems, data requirements and other key vendor systems integration
  • Generates relevant reporting and dashboards
  • Supports systems initiatives through evaluation, documentation and recommendation of systems requirements and operational impact
  • Provides subject matter expertise to perform pre- and post-implementation due diligence for systems initiatives.
  • Develops, generates, and analyzes data/metrics/key performance indicators to support the management clinical trials.
  • Plans, tracks and manage progress of yearly goals/objectives.
  • Provides study milestone reporting
  • Participates in key cross functional teams such as fair market value (FMV)
  • Oversee Clinical Operations strategic initiatives and capabilities planning to scale for the future
  • Connects work streams and initiatives that might otherwise remain siloed
  • Integrates Clinical Operations initiatives with the broader organization
  • Communicates these efforts by linking with the leadership team and extended Clinical Operations team
  • Facilitates investment and workforce planning, quarterly forecasting
  • Oversight and reporting of actual spend and resource utilization
  • Expenditures against department budget as they relate to this role Active participation as a member of the Clinical Operations Leadership Team in driving strategy and team execution
  • Actively participates and/or leads in the development of the Clinical Operation department's vision, standards and successful implementation of process improvements and change.
  • Instills a culture of continuous improvement; acts as a change champion and effectively leads change.
  • Maintain awareness of biopharmaceutical business, operational trends, and external organizational developments to help define future strategic direction.

Director, Clinical Operations

Emergent BioSolutions (formerly PaxVax)
04.2018 - 07.2020
  • Makes key decisions relating to vendors, sites and overall trial strategy
  • Serves as a key decision point for resolving critical issues in trials that may impact the strategic business or financial goals of the Company’s overall business
  • Provides leadership and expertise for the successful management of clinical trials (Phase I - III) across multiple indications through clinical study teams and through the use of CROs or internal resources
  • Responsible for oversight and strategic direction and implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company
  • Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
  • Directs development of SOPs within department and participates in development of collaborative SOP development
  • Contributes to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents
  • Thinks critically and creatively and works independently to determine appropriate resources for resolution of complex problems
  • Manages cross-functional teams or work groups as well as direct reports
  • Demonstrates understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
  • Presents before executive staff
  • Develops RFPs, selection of CROs/vendors, and management of external resources
  • Oversees management of international clinical trials within designated program budgets and timelines
  • Effectively communicate scientific, medical, and organizational concepts to internal and external teams.
  • Initiates, and leads departmental or interdepartmental strategic initiatives.

Director, Clinical Operations

Immune Design
10.2016 - 01.2018
  • Administers clinical operational plan and incorporates the study and scientific plan.
  • Manages operations teams responsible for multiple early stage clinical programs (Phase 1 2 and 3 studies).
  • Interacts within a matrixed environment that includes subject matter experts in clinical, project management, regulatory, commercial, manufacturing, discovery research.
  • Oversees and trains in-house study leads as well as CRO in conduct of pre-study, site-initiation, monitoring, and closeout visits.
  • Oversees management of clinical supplies, work with and manage CROs and recruit investigators.
  • Organize investigator meetings and set up internal systems as needed.
  • Assist in writing study protocols, final study reports, SOPs, safety reports, and design and implementation of CRFs.
  • Oversee development of study related documents and overall direction for the clinical sites to establish protocol development.
  • Ensures compliance with Good Clinical Practices, Good Manufacturing Practices, and regulatory guidelines.
  • Recommends and implements innovative process ideas to impact clinical trials management.
  • Oversees development and management of clinical budget and the development of contingency plans for clinical trials.
  • Acts as a cross functional liaison to ensure study plan aligns with business development strategies.
  • Perform background research analysis and ongoing research analysis during the conduct of the clinical trials.
  • Oversees development of Case Report Forms, Informed Consent Forms, and IRB submission materials.
  • Evaluates clinical data, data quality, and other study information to assist in providing interim and final reports on projects.
  • Prepares research reports by confirming Case Report Form (CRF) and Severe Adverse Event (SAE) reporting, identifying protocol deviation, summarizing information, citing patient response, adhering to federal guidelines.
  • Collects information by searching and interviewing investigators and patients, comparing information discovered to information specifications, and preparing correspondence.
  • Travel to investigator meetings and medical conferences, as well as occasional interactions with study sponsors and their staff.

Associate Director - HIV

Gilead Sciences, Inc.
01.2014 - 10.2016
  • Manages trial process primarily through members of the Clinical Operations team
  • Manages budget responsibility for large trials
  • Makes key decisions relating to vendors, sites and overall trial strategy
  • Serves as a key decision point for resolving critical issues in trials that may impact the strategic business or financial goals of the Company’s overall business
  • Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources
  • Responsible for oversight and strategic direction and implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company
  • Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
  • Directs development of SOPs within department and participates in development of collaborative SOP development
  • Contributes to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents
  • Contributes to development of abstracts, presentations, and manuscripts
  • Manages study teams to ensure deployment of resources
  • Travels nationally and internationally as required
  • Represents the company at professional events and presents company clinical initiatives and findings at such events
  • Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff, and mentor junior staff
  • Solves complex problems and uses highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines
  • Successfully develops, implements, manages and completes complex clinical trials and manages vendor relations
  • Thinks critically and creatively and is able to work independently to determine appropriate resources for resolution of complex problems
  • Demonstrates excellence in complex project management and effectively manages multiple projects/priorities
  • Manages cross-functional teams or work groups as well as direct reports
  • Demonstrates understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
  • Presents before executive staff
  • Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources
  • Manages international clinical trials within designated program budgets and timelines
  • Ability to manage budgets.
  • Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.
  • Initiates, and leads departmental or interdepartmental strategic initiatives.

Associate Director/ Clinical Operations Program Lead

MedImmune
08.2012 - 12.2013
  • Designs the clinical operational strategy for the iPDP. Provides Clinical operational input to the clinical section of the iPDP (Module E, Clinical Development Plan (CDP)) with Medical Director.
  • Responsible for providing expert clinical operational input into: iPDP, CDP, PCS, Clinical Study Protocol (CSP), and Clinical Study Report (CSR), to ensure seamless delivery of studies through effective collaboration.
  • Responsible for delivering differentiated and robust operational design options for review at Investment Decision Governance interactions (i.e. PDT, iMED, SCR, PDC, PRB, and others as appropriate).
  • Oversees the operational delivery of the Clinical Study Program from PCS to final CSR and through to study closed and archived to agreed budget, time and quality and aligned with Key Performance Indicators (KPIs).
  • Responsible for planning and leading interactions, including issue escalation and resolution between Clinical Operations, Clinical Trial Teams, Clinical Sub-Team and the PDT
  • Accountable for driving accurate clinical resource forecasting.
  • Liaise with Capacity Planning Group to ensure adequate resource allocation
  • Liaise with Functional Area Heads to determine CST and CTT resource as appropriate
  • Collaborate closely with Resource Performance Management to deliver ongoing program feasibility assessment
  • Develop and manage clinical program risk mitigation plans to ensure delivery to timelines, budget and quality with efficient resource utilization.
  • Work with the Clinical Program Manager(s) (CPM) assigned to study (ies) on the program to develop the risk mitigation/contingency plans for the individual study (ies)
  • Provide the CST and Clinical Trial Team (CTT) with necessary PDT project planning information e.g. timelines, risks, standards documentation and templates
  • Engaged appropriately for study related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance and Clinical Operations.
  • Review of the Clinical Study Reports and any regulatory submissions. Co-leads the clinical operational team contribution along with Regulatory.
  • Responsible for the initial forecasting and management of all Clinical Operations delivery related costs and then oversight when given to the CPM for any given study
  • Review of clinical study budgets, contracts, and costing for studies at all stages of development
  • Accountable to the PDTL for delivering to clinical budget
  • Participates in the PDT budget and resource review.
  • Accountable for the quality of study delivery planning information into relevant planning systems (eg.; OPAL, IMPACT) and the direct input of clinical forecasting into OPAL
  • Collaborate with TA Director to drive best practices, ensuring project and functional objectives are aligned and cascaded to team members.
  • Partners closely as a peer with the Medical Director and other members of the Clinical Sub-Team including but not limited to providing expert clinical operational feasibility input to PCS development.
  • Since the COPL is accountable for overall program deliverables, they will maintain oversight of their compound’s study deliverables by close interaction with the CPMs who are deployed to the program through the GCSD.
  • Works with the Global Clinical Study Delivery Leadership Team to obtain resources, such as Clinical Program Managers (CPMs) and Clinical Research Associates (CRAs) to manage individual clinical trials.
  • Provide coaching and mentoring for development and performance management to the CPMs who support their studies.

Sr. Clinical Program Manager

MedImmune
05.2011 - 08.2012
  • Represents Clinical Operations on the Product Development Team (PDT).
  • Provide clinical operational strategy for Integrated Product Development Plan (iPDP).
  • Manager of Clinical Budget that rolls up to PDT
  • Manages the Clinical Sub-Team (CST)
  • Provides matrix management of functional area representatives to cross-functional clinical trial teams.
  • Leads/oversees multiple cross-functional clinical trial teams.
  • Defines and manages accountabilities for all clinical trial team members.
  • Collaborates with cross-functional area heads to ensure proper resourcing for assigned trials.
  • Authors Protocol Concept Sheet (PCS) and Study Protocol.
  • Develops outsourcing specifications for vendor requests for proposal and scope of work agreements.
  • Manages study team in vendor selection.
  • Manages the vendor(s) throughout the life of assigned clinical trial(s).
  • Selects investigational sites with input from Clinical Development, CCS, and vendors.
  • Reviews and refines Clinical Operations Plans including study monitoring and other plans.
  • Oversees investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs
  • Leads ongoing review of data to ensure quality and consistency.
  • Plans and conducts investigator meetings and ad boards, etc.
  • Develops and manages program budget(s) and oversees site agreement/budget negotiation process.
  • Develops and manages program timelines.
  • Oversees the submission of the trial-related and essential documents to the Trial Master File.
  • Identifies and provides solutions to clinical trial issues.
  • Provides input into non project related activities and development of procedures as requested.
  • Mentors staff and serves as a resource for new employees.
  • Line management of CPMs and ACPMs.
  • Provides or facilitates training to clinical study teams on protocol specific topics.
  • Participates as appropriate in internal and external audits.

Sr. Clinical Project Manager

Allos Therapeutics
08.2010 - 01.2011
  • Responsible for assisting with recruiting, hiring, mentoring and managing Clinical Trial Managers, Clinical Research Associates, and Clinical Operations Personnel.
  • Defines scope of work within projects, resource needs and allocation.
  • Facilitates and troubleshoots program issues and ensures adherence to timeline and financial requirements.
  • Participates in determining outsourcing strategy and vendor selection, working closely with Pharmaceutical Project Management and Outsourcing to establish and maintain timelines and budgets.
  • Development, coordination and tracking of program training; and, oversee and/or participate in, training and mentoring junior project support staff.
  • Work with project team to track, review and report performance of CRO and/or other third-party vendors against contract, expectations and project timelines.
  • Oversee development and maintenance of internal databases and project plans.
  • Design and coordinate the development process for procedures, document management tools and enhancement of the computerized clinical tracking systems. Designs and implements additional databases to improve tracking and efficiency of operations including study specific documents and forms.
  • Monitor and coordinate efforts of cross-functional project teams.
  • Serve as primary project contact with CRO to ensure communication integrity.
  • Develop and initiate feasibility studies and patient recruitment strategies.
  • Oversee the management of the operational aspects of clinical trials including protocol development, investigator recruitment, patient enrollment, study specific guidelines and processes and quality of data collection.
  • Foster positive working relationships with key investigators, opinion leaders and collaborators.
  • Coordinate preparation of clinical document team in support of regulatory submissions as well as review of documents such as Investigator Brochures, clinical study reports and annual reports.
  • Prepare and present project information at internal and external meetings to represent the program(s), including scientific meetings
  • Maintains knowledge of relevant regulations and guidelines and ensures compliance with GCP standards, applicable regulations, Standard Operating Procedures (SOPs) and study specific documents, processes, policies and procedures and meets quality and timeline metrics. Coordinates and ensures consistency of study specific templates/guidelines.
  • Perform periodic evaluation of the performance of direct reports.
  • Partner with Project managers to develop and implement process improvements.

Global Project Manager (Regionally based)

Research Pharmaceutical Services, Inc. (RPS)
06.2007 - 08.2010
  • Management of Global Phase 2 Pancreatic & Prostate Cancer Studies
  • Management of Phase 2 Breast & Colorectal Cancer Studies
  • Management of Investigator Meetings
  • Ongoing Client Relations
  • Recruit Talented Clinical Staff
  • Clinical Site Development
  • Contract Development
  • Global Budget/Fiscal Responsibility

Clinical Project Manager

Wellstat Therapeutics Corporation
10.2003 - 06.2007
  • Management of Phase 3 Pancreatic Cancer Study
  • Management of Phase 2 Colorectal Cancer Study
  • Management of 2 Phase 1 Cancer Studies
  • Protocol Development
  • Clinical Site Development
  • Contract Development
  • Vendor Selections/Management
  • CRA Management

Senior Clinical Trial Manager (Regionally based)

Omnicare Clinical Research
01.2002 - 01.2003
  • Establish and maintain positive client interactions/communications with study sponsors regarding clinical issues and project goals
  • Interact with investigators and/or site personnel as needed to ensure a smooth study flow
  • Coordinate investigator meetings
  • Participate in client and project team meetings/presentations during the course of clinical trials
  • Plan and attend study start-up meetings with sponsors
  • CRA management for 15+ CRA’s and SR. CRA’s
  • Clinical Trial Management
  • Overall clinical budget
  • Training
  • Clinical staff review

Clinical Scientist (Regionally based)

Quintiles Incorporated
01.1998 - 01.2002
  • Clinical/Line Manager for three Sr. CRA’s, two CRA’s and a CTA
  • Clinical project management of a 950 patient phase 3 study
  • Client interaction
  • Development of clinical strategies
  • Case Report Form Development
  • Development and maintenance of monitoring budget
  • Development and maintenance of monitoring plan
  • Project tracking
  • Investigator Meeting presentations

Senior Clinical Research Associate

Knoll Pharmaceutical Company, BASF Pharma
01.1995 - 01.1998
  • Monitoring cytotoxic chemotherapy clinical trials Phase 1 and Phase 2
  • Site selections
  • Budget negotiations
  • Regulatory document compilation
  • Protocol development
  • Case report form development
  • Study site initiations/Study site closures/Routine monitoring

Clinical Research Associate

University of Maryland Cancer Center
01.1992 - 01.1995
  • COG protocol conduct
  • Phase 1 patient accrual and protocol conduct
  • IRB submissions
  • ICF development
  • Budget development
  • PK collection and processing
  • Regulatory document compilation
  • In-house protocol training

Education

M.A. - Legal and Ethical Studies

University of Baltimore
Baltimore, MD
01.1995

Certified Nursing Technician Training - undefined

University of Maryland Medical System
01.1993

Certified Phlebotomist (ASPT) - undefined

Essex Community College
Essex, MD
01.1992

B.A. - History

University of Baltimore
Baltimore, MD
01.1991

Skills

  • Operational efficiency
  • Motivational attitude
  • Scheduling coordination
  • Workforce management

Affiliations

  • Affiliate Member, American Society of Clinical Oncology, ASCO
  • Active member, Drug Information Association, DIA
  • Active member, Association of Clinical Research Professionals, ACRP

Publications

  • Gaur AH, Kizito H, Prasitsueubsai W, Rakhmanina N, Rassool M, Chakraborty R, Batra J, Kosalaraksa P, Luesomboon W, Porter D, Shao Y, Myers M, Ting L, SenGupta D, Quirk E, Rhee M. Safety, Efficacy and Pharmacokinetics of a Single-Tablet Regimen containing Elvitegravir, Cobicistat, Emtricitabine and Tenofovir alafenamide (E/C/F/TAF) in Treatment-Naïve HIV-Infected Adolescents: a Single-arm, Open-label, Phase 2/3 Trial. Lancet HIV. Accepted 08 August 2016. In press.
  • Myers, Michael R. Knowing Ethical Behavior CALGB Newsletter Volume 4, Number 2, 1995, Consortium Connections Volume 9, Number 2, 1995
  • Villalona- Calero M, Eder J, Toppmeyer D, Allen L, Velagapudi R, Myers M, Amato A, Kagen-Hallet K, Razvillas B, O'Connor L, Fram R, Kufe D, Von Hoff D, and Rowinsky E. 1998. Phase I and Pharmacokinetic (PK) study of LU79553, A Novel Bis-Naphthalamide on a Daily x 5 Schedule. [Abstract]. Proceedings of the 10th NCI-EORTC symposium on new drugs in cancer therapy, abstr# 249. (Published)
  • Villalona- Calero M, Eder JP, Toppmeyer D, Allen LF, Velagapudi R, Myers M, Amato A, Kagen-Hallet K, Razvillas B, O'Connor L, Fram R, Kufe D, Von Hoff D, and Rowinsky E. 1998. Phase I and Pharmacokinetic (PK) study of LU79553, A Novel Bis-Naphthalamide on a Daily x 5 Schedule. [Abstract]. Proceedings of ASCO (Published)
  • TC Lynch, JP Eder, R Fram, LF Allen, M Myers, K Jakimowicz, D Rodriguez, Y Bankmann, R Velagapudi, DW Kufe, 1998. A Phase Clinical and Pharmacokinetic Study of Cemadotin, a Dolastatin Analogue, as a 5-Day Continuous Intravenous Infusion (CIVI) In Pretreated Solid Tumor Patients (Meeting abstract #808). 1998 ASCO Annual Meeting
  • Villalona-Calero MA, Eder JP, Toppmeyer DL, Allen LF, Fram R, Velagapudi R, Myers M, Amato A, Kagen-Hallet K, Razvillas B, Kufe DW, Von Hoff DD, Rowinsky EK. Phase I and pharmacokinetic study of LU79553, a DNA intercalating bisnaphthalamide, in patients with solid malignancies. J Clin Oncol. 2001 Feb 1;19(3):857-69

Training

  • Biomedical Research – Basic/Refresher
  • Conflicts of Interest – Basic Course
  • Good Clinical Practice: GCP for Clinical Trials with Investigational Drugs and Medical Devices
  • Information Privacy Security – Basic Course
  • Institutional/Signatory Official: Human Subject Research
  • IRB Members – Basic Course

Timeline

Senior Clinical Operations Lead

Forte Biosciences, Inc
01.2025 - 09.2025

Sr. Director, Clinical Operations, Head of Clinical Vendor Management

Neumora Therapeutics
07.2020 - 06.2024

Director, Clinical Operations

Emergent BioSolutions (formerly PaxVax)
04.2018 - 07.2020

Director, Clinical Operations

Immune Design
10.2016 - 01.2018

Associate Director - HIV

Gilead Sciences, Inc.
01.2014 - 10.2016

Associate Director/ Clinical Operations Program Lead

MedImmune
08.2012 - 12.2013

Sr. Clinical Program Manager

MedImmune
05.2011 - 08.2012

Sr. Clinical Project Manager

Allos Therapeutics
08.2010 - 01.2011

Global Project Manager (Regionally based)

Research Pharmaceutical Services, Inc. (RPS)
06.2007 - 08.2010

Clinical Project Manager

Wellstat Therapeutics Corporation
10.2003 - 06.2007

Senior Clinical Trial Manager (Regionally based)

Omnicare Clinical Research
01.2002 - 01.2003

Clinical Scientist (Regionally based)

Quintiles Incorporated
01.1998 - 01.2002

Senior Clinical Research Associate

Knoll Pharmaceutical Company, BASF Pharma
01.1995 - 01.1998

Clinical Research Associate

University of Maryland Cancer Center
01.1992 - 01.1995

Certified Nursing Technician Training - undefined

University of Maryland Medical System

Certified Phlebotomist (ASPT) - undefined

Essex Community College

B.A. - History

University of Baltimore

M.A. - Legal and Ethical Studies

University of Baltimore

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