Hong An

Head of Clinical Reseach @ Lantheus

About

Accomplished clinical development expert with extensive experience leading cross-functional teams and managing Phase I-IV clinical trials across diverse therapeutic areas, including Oncology, hematology, Cardiovascular/Metabolic Diseases, and Rare Diseases. Proven success in both sponsor and CRO settings, with expertise spanning startup environments, mid-sized biotechs, large pharmaceuticals, and CROs. Strong collaborator with a track record of driving strategic initiatives and fostering partnerships with internal and external stakeholders. Key Highlights: -Medical Doctor | US Medical Licensing Examination (USMLE) certified MD -20+ years of experience in clinical research, including oncology trials, with a focus on both sponsor and CRO perspectives -Extensive experience in Lymphoma, Leukemia, Solid Tumors (lung, breast, skin), and Radio Pharmaceutical trials (Phase I-IV) -6 years of clinical practice in Hematology/Oncology, specializing in bone marrow and stem cell transplant Attending physician for the Stem Cell Transplant Unit, with hands-on experience in Hematology/Oncology and Internist roles -In-depth knowledge of FDA regulations and ICH/GCP guidelines -Strong strategic thinker with excellent communication skills; experienced in working with KOLs, investigators, and internal cross functional teams -Consultant to major pharmaceutical companies on cancer therapies and hematological diseases

Country

United States

City

Greater Chicago Area

Industry

Pharmaceuticals

Skill

Multiple Projects Simultaneously, Regulatory Submissions, Primary Care, Working with Physicians, Electronic Health Records (EHR), Internal Medicine, Patient Safety, Statistical Analysis Plans, Adverse Events, Gene Therapy, Business Development, Presentation Skills, Operations Management, Coaching, Cross-functional Team Leadership, Presentations, Strategic Planning, Analytical Skills, Business Strategy, IND

Experience

Head of Clinical Reseach

Lantheus

2023-1 - 2024-12 · 2 yrs

United States

Built and led a clinical development team, developing strategies and plans for pipeline and in-line assets. Led cross-functional team the development of clinical development plans (CDPs), synopses, and protocols. Oversaw clinical research activities for multiple programs, Conducted medical due diligence on assets under consideration for potential acquisitions • Collaborated with global program leads and cross-functional teams, including Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, and Translational Medicine, ensuring alignment with asset strategies, CDPs, and regulatory submissions Engaged external stakeholders and organized advisory board meetings on clinical research planning.

Senior Medical Director

Karyopharm Therapeutics Inc.

2021-8 - 2022-9 · 1 yr 2 mos

United States

Global medical team lead for Selinexor clinical trial strategy development, trial design and execution. Primary medical monitor for DLBCL (P2, P3), melanoma (P2), colorectal cancer (P2); supported endometrial cancer (P3) and FDA dossier preparation. Led cross-functional clinical team, collaborated with PV, RA, Stats, ClinOps, DM, Med Affairs, and Commercial teams. Contributed to LCM strategy development. Engaged and collaborated with KOLs, investigators and regulatory agencies.

Country Lead Monitor, US

Bayer

2014-12 - 2021-8 · 6 yrs 9 mos

Chicago, Illinois

Led clinical studies (Phase I-III) of NSCLC, solid tumors, gene therapy, etc. First go-to person for study issues, analyzing and reporting of safety data, protocol violations. Consulted and interacted with KOLs on disease targeting, and study designs, applied learnings to synopsis and protocol development, such as endpoints selection, inclusion and exclusion etc. Oversaw investigator selection. Managed protocol training for internal teams and external teams Participated in data review, CSR, and core country dossier preparation for regulatory agencies.