Malinda Longphre

About Malinda Longphre

Innovative clinical research executive and entrepreneurial scientist who designs, launches, and governs global Phase 1-3 trials for biotechnology and pharmaceutical companies. Hands-on leader who: manages and implements clinical strategies, operations, and programs; directs 10 staff; and prepares and administers an up to multimillion dollar study budget. Advances clinical development including efficacy, safety, and robustness; and propels CRO performance. Actively contributing to teams: presents findings to stakeholders (e.g, potential investors, regulatory authorities, KOLs); secures venture funding; and participates in due diligence, M&A, and integration efforts. Expertise: Inflammatory- and Immunology-Related Diseases, Inhaled and Injectable Products, GCP, Regulatory Compliance, Quality Management, Risk Management, Strategic Planning, KPIs, Team Building.

Experience

1. Vice President, Clinical Operations Executive Director, Clinical Operations

   Connect Biopharma

   Jan 2020 — Present · CA

   Built a U.S-based 10-person global clinical operations team to carry out Phase 1-3 global studies for a biotechnology company based in China and the U.S. Advocates and advances the clinical development pipeline for products in the dermatology, respiratory, immunology therapeutic areas, with both biological and small molecule assets. Galvanizes the performance-led management culture by delivering exceptional leadership and coaching to staff. Executes on the Clinical Operations strategy to achieve goals while sustaining productivity and efficiency gains. Participates in Regulatory and Ethics submissions for the U.S, EU, Ukraine, China, South Korea, Australia, and New Zealand by writing clinical sections of INDs (CTD M2 and 5), CTAs, annual reporting; also represents Connect At meetings with the US FDA. Fosters collaboration with investigators, KOLs, DSMB, ethics committees, clinical research networks, patient groups, and local Health Authorities. Promotes hands-on relationship building through face-to/face meetings. Negotiates contracts with global CROs for Phase 2-3 studies, administering budgets of $15-65M. Confirms accuracy and timeliness of clinical operations budget forecasts. Implements strategies to remediate resource gaps. Participated in regular SOX audit exercises by external and internal auditors. Coordinates pharmacovigilance safety data handling to track and report adverse patient events. Oversees data management and biostatistics, sharing clinical study results with Connect key stakeholders. Key Results Took part in hiring the CMO, HR, Regulatory, QA and CMC leaders and operational positions. Completed three Phase 2 monoclonal antibody studies and prepared for Phase 3 study start-up. Contributed to the effort to take the company public in 2021 by: arranging the internal financial infrastructure for reporting clinical spend and audits, raising money, and forging awareness.

Education

• University of North Carolina at Greensboro

  Bachelor of Arts - BA, Biology

• The Johns Hopkins University

  Doctor of Philosophy - PhD, Environmental Health Sciences--Pulmonary Physiology

  1995

• University of North Carolina at Greensboro

  Master of Arts - MA, Biology

  1991

• The Johns Hopkins University

  Postdoctoral Fellowship, Molecular & Cell Biology of the Lung--Genetics of Asthma

  1995 — 1996

• University of California, San Francisco

  Postdoctoral Fellowship, Mucus Gene Regulation

  1996 — 1998