Jennifer Herring Email & Phone Number

Lausanne, Vaud, Switzerland, Ch

• Strategic Support: Partner with the CMO to develop and execute the medical strategy of the company, including clinical development, clinical operations, medical affairs, biometrics, regulatory and patient safety initiatives.• Communication: Serve as a liaison between the CMO and internal/external stakeholders, including executive leadership, department heads, and external partners. Ensure clear and consistent communication of the CMO’s vision and priorities.• Operational Oversight: Manage the day-to-day operations of the Office of the CMO, monitor and analyze resources, budget and capital allocation across the function to align with company strategy. Lead the tracking and updates for all headcount/vacancies within the function and provide regular updates to the CMO LT. Identify potential operating efficiencies and help drive function to solutions.• Meeting Preparation & Follow-up: Organize and prepare for key meetings, including executive leadership team meetings, board presentations, and external engagements. Follow up on action items to ensure timely completion• Stakeholder Engagement: Build and maintain strong relationships with key stakeholders across the organization, including R&D, regulatory, commercial, and compliance teams. Foster collaboration and ensure alignment with the CMO’s objectives.• Corporate Objectives: Assist CMO in developing corporate goals applicable to the office of the CMO, ensure alignment of cascading goals across the business. Foster cross-functional collaboration to ensure alignment with the CMO’s objectives.• Change Management: Support the implementation of organizational change initiatives led by the CMO, ensuring alignment and buy-in from relevant stakeholders.• Project Management: Lead and manage our global Project Management function

Lausanne, Vaud, Switzerland, Ch

New York, New York, Us

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Summit, New Jersey, Us

• Currently Leading Multiple Myeloma (MM) Therapeutic Area (TA) Clinical Research Scientist (CRS) Team with in Global Clinical Research and Development.• Successfully built and managed a team of 28 global CRS with a high rate of employee retention.• Represent the MM Therapeutic Area on behalf of the Physician TA Head at both internal and external venues including the Global Project Teams, governance committees, clinical development teams, data monitoring committees, advisory boards, steering committees, regulatory interactions etc.• Key member of Cellular Therapy Clinical Center of Excellence, partnering across indications to ensure patient safety and harmonization of data collection/review.• Maintains the highest level of scientific and clinical knowledge in treatment of multiple myeloma patients. • Develop data collection and cleaning standards in partnership with other TA Lead CRS to ensure consistency across compounds in development.• Directly responsible for quality of clinical data and section content for global health authority submissions for lenalidomide and pomalidomide leading to numerous approvals of these compounds in the treatment of MM.• Ensure all MM Project Team, Franchise and Management goals are met on time and with high quality. • Planning and management of TA resource allocation and operating budget for internal and external expenses in line with departmental and clinical objectives.• Known company wide as an expert in CRS responsibilities and considered the “go-to” resource for escalation and resolution of issues.• Selected by Sr. Management to participate in Leadership Mentoring Program.

Independent consultant to multiple Pharmaceutical and Biotech companies, providing project management, monitoring and auditing services •Function as a clinical project manager, both in-house and regional•Conduct of monitoring visits •Comprehensive data review, including design of patient data profiles, review of disease response data and generation of data queries.•Management of regional CRAs, including trip report review.•Creation of case report forms and completion guidelines, including eCRFs.•Design and production of specific study documents, including: monitoring plans, study reference manuals, training materials, study tools, tracking forms, etc.•Leadership and training of project team members, including CRAs and support staff.•Creation of Standard Operating Procedures, forms, trip report templates and operational standards.•Organization of investigator meetings and data safety monitoring board meetings, including design of presentations and meeting materials.

New Brunswick, Nj, Us

Responsible for global study management of phase I and II studies in hematologic malignancies, multiple myeloma and prostate cancer• Management of timelines, study budget and regional monitoring staff• Design, production and implementation of specific study documents, including: protocols, eCRFs, project and monitoring plans, study reference manuals, training materials, study tools, tracking forms and final study reports.• Negotiation of budgets for outsourced activities and vendor management• Clinical review and validation of CRF data and Serious Adverse Event (SAE) reports.• Conduct of monitoring visits including site selection, initiation, monitoring and close out to ensure compliance with GCP’s and FDA regulations.

Us

• Identify, recruit, and initiate clinical investigative sites using feasibility tools, including phone interviews and qualification visits.• Initiate, monitor and closeout Phase 1 - 3 clinical trials in compliance with FDA, ICH/GCP and sponsor regulations; submit monitoring reports within Sponsor timelines.• Review and source data verification of CRF data and queries.• Collect, track and maintain regulatory and other study-specific documents. • Management of Investigator sites to meet study enrollment goals and deliverables.• Comprehensive data review, including design of patient data profiles, review of disease response data and generation of data queries.• Management of regional CRAs, including trip report review.• Medical writing for documents, such as: Protocols, investigator brochures, regulatory authority annual updates and clinical study reports.

Responsible for full scope management of Phase I – III Oncology/Hematology clinical trials, ensuring on-time, on-budget performance.• Lead multi-disciplinary project teams of lead and regional CRAs, Safety Monitoring, Data Management, Biostatistics, Programming and Medical Writing.• Provided leadership and mentoring to the Sr. CRAs, CRAs, administrative personnel and contract project staff who reported directly to me.• Designed and authored Oncology specific study documents, including: Protocols, CRFs, monitoring plans, study reference manuals, training materials, and final study reports.• Coordinated interim data review and production of annual IND reports. • Clinical review and validation of CRF data and Serious Adverse Event (SAE) reports.• Prepared full project operation reports, demonstrating adherence to timelines and budgets.• Performed site monitoring visits, ensuring compliance with GCP’s and FDA regulations.• Created company Standard Operating Procedures, forms, and operational standards.• Worked with Business Development to create full costing and proposal documents as well as capabilities presentations.• Selected by Senior Management to speak at key industry meetings (DIA, Barnett).

Gaithersburg, Maryland, Us

Responsible for all aspects of clinical development of a monoclonal antibody with oncology indications.• Coordinate and manage Phase I – III clinical trials with in-house clinical research associates, independent contractors and contract research organizations.• Responsible for developing protocols, case report forms and all other trial materials.• Develop and manage budgets and timelines for clinical development.• Work effectively as a team leader among other departments to ensure quality FDA submissions.• Establish and maintain relationships between the company and all Principal Investigators.• Negotiation of vendor contracts, management of vendors.

Durham, Nc, Us

Assisted in researching, writing and conducting clinical trials primarily for Hematology and Oncology indications and in addition, Infectious Disease, Dermatology, Cardiology and Healthy Volunteer studies.• Planned, implemented and managed multiple clinical trials at a total of 40 sites.• Managed in-house and contract CRA's as well as other research personnel.• Conducted site selection, qualification, monitoring and close out visits at clinical sites to ensure compliance with GCP’s and FDA regulations.• Accelerated project timelines by organizing and appropriately delegating responsibilities.• Developed case report forms, source documentation, model consent forms and other tools to improve the quality of data collected during trials.• Supervised, planned and conducted education for monitors, study coordinators and investigators.• Coordinated review of adverse events, pharmacokinetic/laboratory results, response data and other reports from ongoing clinical trials.• Obtained bids from multiple vendors and effectively lowered clinical trial costs.• Assisted in developing Standard Operating Procedures and forms for clinical development.

Birmingham, Alabama, Us

Birmingham, Alabama, Us