Fei Shen

Senior Director, Compound Development Team Leader (CDTL), Oncology, Innovative Medicine @ Johnson & Johnson

About

Seasoned drug discovery and development leader with a proven track record of advancing transformational oncology medicines from target validation through regulatory approval and global commercialization. Experience spans multiple therapeutic modalities, including multispecific antibodies (Pasritamig KLK2×CD3, PSMA×CD28), antibody-drug conjugates (ADCs), targeted radioligand therapies (225Ac), CAR-T cell therapies, and PARP inhibitors (AKEEGA®).### Leadership Experience at Johnson & JohnsonDiscovery Leadership- Discovery Leader within the Johnson & Johnson Prostate Cancer Disease Area Stronghold.- Led cross-functional discovery teams and drove the advancement of three KLK2-targeted therapeutic programs from target validation to IND/Phase 1 readiness: - JNJ-8343 (Pasritamig, KLK2×CD3) - JNJ-9414 (Autologous KLK2 CAR-T) - JNJ-6420 (225Ac-KLK2 Targeted Radioligand Therapy)Early Clinical Development- Compound Development Team Leader (CDTL) responsible for global development programs from preclinical candidate selection through clinical proof-of-concept.- Led matrix CDT across Clinical Development, Translational Research, CMC, Regulatory Affairs, Medical Safety, Clinical Pharmacology, Medical Affairs, Commercial, Market Access, Data Science, Legal, and non-Clinical.- Led global development of multiple innovative oncology assets, including: - Pasritamig + PSMA×CD28 (JNJ-9401) Co-stimulatory TCEs - JNJ-8902 TMEFF2xCD3 - PSMA ADC Late-Stage Development & Commercialization- CDTL for AKEEGA® (niraparib + abiraterone acetate), leading global Phase 3 registrational development, regulatory submissions, worldwide launch, and lifecycle management.- Played a key leadership role in bringing AKEEGA® from late-stage development to regulatory approval and commercialization.### Key Achievements- Contributed to the advancement of 5 NMEs, 4 INDs, and 1 regulatory approval (AKEEGA®) across the Johnson & Johnson Oncology portfolio.- Extensive experience leading multidisciplinary global teams across discovery, translational medicine, clinical development, regulatory strategy, and commercialization.

Country

United States

City

Collegeville

Industry

Pharmaceuticals

Skill

Drug Discovery, Pharmacology, Drug Development, Pharmaceutical Industry, Cell Therapy

Experience

Senior Director, Compound Development Team Leader (CDTL), Oncology, Innovative Medicine

Johnson & Johnson

2025-10 - Present · 1 yr

Director, Compound Development Team Leader (CDTL), Oncology, Innovative Medicine

Johnson & Johnson

2023-5 - 2025-10 · 2 yrs 6 mos

• Compound Development Team Leader (CDTL) of early prostate assets, including T cell redirector, co-stim antibody (pasritamig+PSMAxCD28), and ADC for treating advanced solid tumors. Leading matrix asset teams through preclinical candidate selection, NME declaration, regulatory submission, FIH study, and early clinical development (to clinical PoC). • CDTL of AKEEGA® (Niraparib+Abiraterone Acetate), responsible for executing registrational phase 3 studies, global filing and launching activities, and lifecycle management of the brand. • Ph.D. student co-advisor with University of the Sciences in Philadelphia/Saint Joseph's University. • Program Director of the Janssen Diversity in Drug Discovery and Development (4D) Fellowship Program

Associate Director, Compound Development Team Leader (CDTL)

Johnson & Johnson

2022-3 - 2023-5 · 1 yr 3 mos

Spring House, Pennsylvania, United States

• Compound Development Team Leader (CDTL) of T cell redirector, co-stim antibody, PET tracer, ADC, and alpha radioligand assets for the treatment of advanced prostate cancer. • Lead global cross-functional compound development teams (Discovery, Clinical, CMC, Regulatory, Medical Affairs, Legal, Commercial, etc) and provide leadership to the global development and execution of the asset strategy. • Ph.D. student co-advisor with University of the Sciences in Philadelphia/Saint Joseph's University. • Program Director of the Janssen Diversity in Drug Discovery and Development (4D) Fellowship Program

Principal Scientist, Oncology Therapeutic Area

Johnson & Johnson

2021-4 - 2022-3 · 1 yr

Spring House, Pennsylvania, United States

• Oncology Discovery Team Leader of solid tumor CAR-T/multi-specific T cell redirection and targeted radio-conjugate programs - successfully discovered and advanced JNJ-8343 CD3 bispecific T cell redirector and JNJ-9414 CAR-T from discovery to global first-in-human trials. • Discovery Leader on three Compound Development Teams (CDT) throughout the therapeutics lifecycle. • Acting Compound Development Team Leader (CDTL) of co-stim bispecific antibody and alpha radioconjugate therapeutic programs.