Basel, Switzerland
Experienced Clinical and Research Scientist, from Bench, Pre-clinical, phase I to IIIb; and from protocol synopsis / start-up activities to filing and approval (FDA, EMEA, Japan, Switzerland, Brazil). Clinical Science Lead for the Revlimid/Rituximab (R2) Lymphoma program (Celgene), Ensovipeb anti-COVID program (Molecular Partners AG). Build and lead clinical science team and activities.
Build and lead the clinical science team and related activities. Overview all clinical studies. Lead clinical scientist on the Ensovipeb anti-COVID program.
- Program Lead Clinical Scientist Lenalidomide and CC-220 -- Partner with the Lymphoma medical lead to provide strategic program planning, scientific leadership across multiple development programs to ensure deliverables are accomplished on-time, on-target and with high quality. -- KOL interactions to discuss key aspects of trial and competitive landscape. -- Provides scientific expertise to different departments and line functions. -- Engaged in business development discussions to assess potential new assets. -- Lead and coordinate team of Scientists. - Clinical Science Lead - Led clinical scientific teams and Core submission team member for the lenalidomide R/R iNHL submission, including 3 global phase III pivotal studies (AUGMENT, MAGNIFY and RELEVANCE studies). -- Interpretation of study results, key messaging and documentation of study results including efficacy and safety parameters. -- Regulatory documents review (CSR, CO, SCE, SCS, ISS, ISE, Meta-Analysis/Matched-Pair Analysis documents, response to HA questions, CCDS, product label, SmPC, RMP, REMS and bridging documents), manuscript review. -- Leading to approval of Lenalidomide+Rituximab in the treatment of r/r NHL by FDA, EMEA, PMDA, Swissmedic, ANVISA. AWARD: Excellence in Delivering Exceptional Results Award: 2020.
- Clinical Science Lead - Led clinical scientific teams and Core submission team member for the lenalidomide R/R iNHL submission, including 3 global phase III pivotal studies (AUGMENT, MAGNIFY and RELEVANCE studies). -- Generate comprehensive data review plan. -- Interpretation of study results, key messaging and documentation of study results including efficacy and safety parameters. -- Regulatory documents review (CSR, CO, SCE, SCS, ISS, ISE, Meta-Analysis/Matched-Pair Analysis documents, response to HA questions, CCDS, product label, SmPC, RMP, REMS and bridging documents), manuscript review. -- Leading to approval of Lenalidomide+Rituximab in the treatment of r/r NHL by FDA, EMEA, PMDA, Swissmedic, ANVISA. - Led and develop a comprehensive plan and specific tools for data review from a cooperative groups study (the REMARC study, LYSARC). Collaboration with cooperative group. Database lock. Briefing Book, regulatory documents review (Type C meeting, sNDA), manuscript review. Leading NCCN guideline update to cat 2B for Lenalidomide. - Coordinate team of Scientists (including delegation of tasks with oversight) - Develop data review tools. - Develop the R&D internal website. - Provides scientific expertise to different departments and line functions. AWARDS: Excellence in Delivering Exceptional Results Award: 2017 and 2019.
- Clinical Science Lead - Led scientific team on a global phase III pivotal study in relapsed/refractory NHL (the AUGMENT study) leading to global approval of Lenalidomide+Rituximab in the treatment of r/r NHL. -- From Protocol development to CSR and filing. -- Site identification and selection. Conduct Investigator Meetings (EU, USA, Japan, China, Brazil) and Site Initiation visits over EU. -- Preparation/coordination and participation to iDMC and Steering Committee. Maintain Safety and Medical Monitoring. Efficacy guidelines. Data Review, narratives, Interim Analysis. Mitigation to reduce screen failures. Recruitment initiatives. Identify trends in data review. - Clinical Science Lead - develop a comprehensive plan and specific tools for data review from a cooperative groups study (the REMARC study, LYSARC). Collaboration with cooperative group. Database lock. Briefing Book and regulatory documents review (Type C meeting, sNDA). -- Leading NCCN guideline update to cat 2B for Lenalidomide. -- Clinical science lead on a phase II study in front line DLBCL Protocol development. Conduct Site Initiation visits over EU and investigator meeting globally. Preparation/coordination and participation to iDMC, Scientific and Steering Committee. - Coordinate team of Scientists (including delegation of tasks with oversight) - Develop data review tools. - Complete all fulfillment and support for compound registration (Briefing Book, synopsis) - Led/participate in multiple global initiatives: Protocol template guidance, Regimen coding initiative, CDRP. - Led and develop the R&D internal website. - Provides scientific expertise to different departments and line functions. AWARD: Living our Values Award: 2017.
- Clinical Science Lead on: -- a global Phase II study in relapsed/refractory DLBCL -- a phase I in Multiple Myeloma. -- a phase IIIb study in relapsed/refractory NHL (the MAGNIFY study) From Protocol synopsis to CSR. Conduct Site Initiation visits over EU and investigator meeting globally. Preparation/coordination and participation to iDMC. Data Review, narratives, Interim Analysis. Mitigation to reduce screen failures. - Develop data review tools. - Complete all fulfillment and support for compound registration (Briefing Book, synopsis) - Led/participate in multiple global initiatives: Clinical Data Review Plan (instructor led training), Patient Profiles, Safety Shells, Scientist on-boarding initiative, Lymphoma manuscript Review team, Regimen Coding initiative. - Create and Led the R&D internal website. - Provides scientific expertise to different departments and line functions. - Participate to the Lenalidomide CDP in Lymphoma.
- Protocol development for Ph. I/II/III Oncology and hematology trials (HCC, NSCL, Breast, Prostate, Hodgkin), and all necessary documents (CRFs, ICFs, Manuals, patient diary, assessments table) following HA guidelines, GCP and internal SOPs. - Regulatory activities: Documentation preparation for EC and Swissmedic (CTA submissions) - Management and coordination of trials, including budget, contracts, logistic, forecasting, and monitoring. - Cross functional management. - Data Management: review, queries, optimization of software, development of tools. - Negotiation with external and internal stakeholders, Pharmaceutical industry, international cooperative groups (lead to implement the STAMPEDE trial in Switzerland).
Ph.D. Biochemistry - Medical Faculty – University of Bern - Switzerland Inselspital, Nephrology and hypertension Dpt Professor FJ Frey/ Professor B Frey -> Prove the fact that insulin regulates the 11beta-HSD2 and should induce hypertension and metabolic diseases in patient with type II Diabetes. - Designed, executed, and supervised in-vivo and in-vitro scientific studies and experiments. - Techniques: mRNA and protein expression, qPCR TaqMan,Cortisol/Cortisone Conversion Assay , flow cytometry, Plasmid Construction, Transfections, Luciferase, β-Galactosidase Assays, promotor activity, Chromatin immunoprecipitation assay. - Composed and presented technical reports, result reports, and scientific publications. - Trained, managed,and supervised staff and junior scientists.