Jennifer Webster Email & Phone Number

Watertown, Ma, Ma, Us

• Committed to productivity for patients, inspired by our team culture. • Responsible for Clin Ops, Data Management, Medical Writing, Reg Ops, IP labeling & distribution plus Patient Engagement.• Advancing REM-422 for the treatment of ACC (R/M) and AML (R/R). Other molecules and diseases to follow.

Cambridge, Massachusetts, Us

Accountable for the global strategy and execution of that strategy to advance assets from PoC to Launch for the benefit of patients with rare disease.

Boston, Massachusetts, Us

Vice-President, Transactional Research (Pilot Program) 2020 - 2021• Identified un-tapped business opportunity to further enhance the structure, execution and financial exchange for research partnerships to discover, develop and define clinical insights & utility • Rallied and leveraged strong internal and external interest with c-level endorsement to drive feasibility assessments and pilot programs to define and expand unique business partnerships for a substantial opportunity as measured by revenue and clinical research with patient impact.Vice-President, Clinical Operations 2018 - 2020Sr. Director, Clinical Operations 2017- 2018Director, Clinical Operations 2016 – 2017• Responsible for establishing and leading Global Clinical Operations (team, processes and structure) to execute clinical research in collaboration with Academic Medical Centers, Public/Private Partnerships, Patient and Co-Operative Groups to develop FMI products and assets.• Contributed as a strategic partner across the organization and at the executive level to provide fundamental input on design, implementation, and execution of global clinical trials and big data collection / aggregation to advance data generation for clinical utility, regulatory and reimbursement discussions• Tasked in building and maintaining collaborations with clinical investigators/advisors/thought leaders and other stakeholders in support of research strategies and business development efforts

Cambridge, Ma, Us

Takeda Oncology 2014-2016Associate Director, Strategic Alliances 2014-2016• Responsible for leading the evaluation, development, implementation, and refinement of Global Medical Affairs initiatives and strategic alliances with external collaborators (KOLs, Academic Institutions, Professional Organizations, and Cooperative Groups)• Accountable for the planning and execution of strategic alliance engagements including Global Advisory Boards, Executive Engagements and Scientific Encounters. Success dependent upon strong partnership with colleagues across Global, Regional and Local Affiliates• Involved in the evaluation, review, and support of Global Investigator Initiated Sponsored Research

Boston, Ma, Us

• Primary responsibilities are to identify external partners, assess areas of mutual interest, define and mitigate risks, and develop long term collaborations through strategic and continuous communication and tactics that address a variety of functional needs on behalf of an organization prior to, during, and following the launch of a block buster drug.• Primary activities include leading cross-functional Alliance & Thought Leader Strategy Teams, developing and executing Communication Plans for product launch and subsequent milestones, developing and executing Scientific Congress Plans, and partnering with stakeholders across the organization to ensure alignment of strategies and tactics for external communications and engagements.• Key external collaborators include joint venture partners, medical societies, thought leaders, academic institutions, and policy stakeholders; key internal collaborators include medical, commercial, clinical development, managed markets, corporate communications and policy representatives.

Boston, Ma, Us

• Lead multiple large cross-functional internal and external teams to drive Phase I, II, and III clinical trials. Successfully delivered 10 clinical trials on time, within budget and in accordance with the protocol and GCP requirements, including the primary registration program for an orphan drug.• Priority emphasis placed upon strong team leadership, effective governance and communication with external partners and robust relationships with clinical study sites.• Efforts focused on consistency of methods, proactive risk mitigation, conflict resolution, metric tracking / analysis and on-time/on-budget completion of all project deliverables. • Responsibilities also include preparation and delivery of internal and external data and strategy presentations, creation of study documents (Protocols, ICFs, etc.), detailed data reviews, and the management of multiple interim analyses to support regulatory discussions / program planning.• Managed and mentored junior staff to meet their project deliverables while also pursuing their own career development opportunities and challenges.

Boston, Ma, Us

• Responsible for contracting outsourced functions for pre-clinical and clinical services. Efforts focused on identifying / qualifying vendors, reviewing proposals, generating contracts as well as on-going monitoring and correction of contract and budget scope. Additional focus was to define strategy for the evaluation, selection and management of outsourced solutions including CROs and Laboratories.• Requirements were effective communication with internal teams and external vendors to ensure efficient, quality and timely achievement of deliverables.

• Function focused on providing business support and financial project management for global regulatory projects. • Primary efforts include proposal and contract generation, budget management and financial close-out of projects spanning pre-clinical through post-marketing regulatory consulting services.

• Services included the creation of budgets and proposal text related to outsourced activities for high-profile international and domestic biopharma clinical trials. • Strategic input was obtained and synthesized from multiple disciplines to inform projects spanning Phase I – IV. Primary interactions were with Clinical, Medical, Data Management, Biostatistics, Medical Writing, Imaging and Regulatory as well as external vendors such as laboratories, drug shipment couriers, and IRBs. • Responsibilities were tied to aggressive timelines, substantial budgets, and complex project resourcing.

• Duties centered on the preparation, collection and management of site regulatory documents and ICFs, the maintenance and distribution of site / study status reports and a Q&A log, and service as a liaison between research sites and Clinical Research Associates. • Further responsibilities were the performance of comprehensive Central Files audits to ensure accurate and complete documentation of Phase II-IV clinical trials and tracking, processing and distribution of Serious Adverse Event / IND Safety Reports.

Master Of Business Administration (Mba)

Bachelor Of Arts (B.A.), Pyschology

Education record