www.orionbiopharma.comIndependent Chief Medical Officer/Consultant, focusing on clinical development and medical monitoring in cardiometabolic diseases (Diabetes, Dyslipidemia, Thrombosis, Heart failure), Autoimmune liver diseases (NASH, PBC, PSC), inflammatory bowel disease (UC and Crohn's disease) and rare diseases (SMA, PAH etc) .

Focused on oral PCSK9 inhibitor clinical development for dyslipidemia indications

Global Clinical Development Lead-NASH(AURORA Phase 3 Study)

Responsibility: Clinical development Lead for IBD ( Ulcerative colitis/Crohn's disease), Pain control & Pruritus indications (Phase 2)Medical development lead for PBC/NASH/CVD (phase 2)

Focused on FXR/FGF21 agonist clinical development in NASH and T2DMLipid mitigation strategy for NASH

Responsibilities:• Develop strategies for evaluating multiple therapeutic areas (NASH, heart failure, Peripheral artery disease, Diabetes, AMD and neurodegenerative disease such as SMA) for develop clinical development plans and clinical research protocols for these molecule programs with emphasis on Investigator-sponsored trials, I/II clinical trials, LCM, incorporate novel biomarkers and technologies as potential predictive companion diagnostics for disease areas and specific molecule programs.•Build internal alignment on these strategies, obtain approval and secure resources to implement these programs.•Provide medical advice to other clinical teams (e.g. extra value team) for the optimal design and conduct of clinical trials including PET imaging as well as orphan diseases.•Provide clinical support for research and clinical leadership for programs in clinical stages (Phase I,II).•Provide productive collaboration with research scientists and assessment of in-licensing opportunities•Establish and maintain close relationships with key opinion leaders (KOLs).

Provide strategic clinical expertise and leadership in clinical developmentProject Team Leader of Thrombosis (anticoagulants)Project Team Leader of T2DM and ObesityProject Team Leader of NAFLD/NASH•Medical Monitor for clinical trials (Phase I/II/III) in areas such as CV, T2DM, obesity, dermatology and liver diseases.•Lead the timely protocol development and execution of phase I/II clinical programs in the treatment of CV, obesity and T2DM populations and other development candidates as required.•Develop and manage the design and content of clinical development plans, clinical research protocols, investigator brochures, consent forms, protocol amendments, medical monitoring plans, and CRFs.•Manage completion of contracts and compensation plans with Investigators.•Develop optimal execution models for clinical programs including use of CRO’s and other external service providers.•Lead the clinical interactions with regulatory agencies.•Establish and maintain excellent relationships with key opinion leaders (KOLs) in CV, obesity and T2DM areas.•Provide ongoing review and consultation on clinical adverse events, including pre-NDA submission review of all US spontaneous reports and liaison with the PV service provider.•Ensure the timely and accurate reporting of clinical safety reports for regulatory purposes.•Provide expert clinical input on potential business development opportunities.•Provide clinical development strategies and the development plan.•Manage clinical development team.•Manage and work with internal regulatory affair staff to communicate with regulatory agents (EU, Health Canada and FDA).

•Responsible for management of pre-IND studies and early stage (Phase I/II) of clinical trials (cardiac arrhythmia, CKD, obesity and diabetes) including protocol design, study conduct and reporting. Duties include assignment as Study Director, Team Member Medicine (TMM), Plans and implements IND and clinical portion of pharmacology Plan locally and/or at international level.•Execution of operational aspects of clinical trials/projects and managing all stages of the IND and Phase I, II trial process including study design, protocol development, PK/PD modeling, review and analysis of efficacy and safety data.•Responsible for interpretations and summarization of preclinical and clinical data and for documenting such information in clinical pharmacology and or medical sections of regulatory documents such as the IB, IND, IND annual reports, Clinical Trial Reports.•Responsible for ensuring adherence to regulatory guidelines (GCP, GLP etc) and HUYA SOPs in preparation, conduct and reporting of clinical trials.•Prepared and reviewed budgets/estimated timeline for IND and Phase I, II studies.•Developed and maintained relationships internally with others involved in the drug development process, and externally with investigators, KOLs and contract research organizations.•Developed credible relationships with KOLs, regulatory and governmental agencies as well as drive the publication process of scientific study data in conjunction with KOLs.