Montreal, Quebec, Canada
Bonjour, Appointed to lead the transformation towards early launch planning for medical affairs evidence generation, I’m currently leading a team of experienced clinical operations associates, delivering impactful data and evidence for internal and external stakeholders. My ambitions are to: - To clear the gaps of the patient journey by ensuring the best innovative treatments reaches the right patient at the right time - To lead transformation and build capabilities enabling breakthrough projects to generate the evidence required for better access and optimal clinical adoption - To collaborate cross-functionally with internal & external stakeholders and to enable AI-driven solution, building strong governance to facilitate smooth and efficient execution Based in Montréal, Canada as a Novartis Canada Evidence Generation Lead, I thrive through challenging situations and collaborations, and will be happy to discuss live on new opportunities. For more details about my current and previous positions, let’s chat!
1. Team Leadership & Capability Building: - Lead and manage a high-performing team of internal and/or external associates including but not limited to Clinical Project Managers, Coordinators, Medical Affair Operation Managers - Build EvGen capability in alignment with national, regional and global guidance 2. Strategic and Operational Leadership of Canada EvGen: - Lead the development, planning, and execution of the Canadian EvGen Strategy across all therapeutic areas - Provide technical and operational leadership for EvGen activities, such as local/regional/global research initiatives as part of an integrated EvGen plan - Providing EvGen expertise to the cross-functional team on conducting EvGen Activities out of scope of Medical Affairs - Report and provide expertise to EvGen governance at Region and Global level - Manage budget of planned and active EvGen activities - Serve as national point-of-escalation for local clinical trial issues - Support Medical Affairs Canada stakeholders in identifying, assessing and managing performance of new/existing Third-Parties - Ensure audit- and inspection-readiness of EvGen area - Support Medical Affairs Canada stakeholders in identifying, assessing, qualifying and managing performance of new/existing Third-Parties in compliance with Novartis procedures and guidelines, and in collaboration with the cross-functional team - Oversee local implementation of all evidence-related systems in collaboration with Governance - Lead continuous improvement of evidence procedures and workflows
Medical Affairs - Innovative Medicine within Health Research & Data To cover the Health gap across Canada. As part of the Medical team, I handle several transverse roles aiming to integrate the best quality of evidence to Novartis Medical Affairs, fit-for-purpose within local, regional and global strategy. 1. Evidence Generation Planning: answering strategic imperatives by building the evidence generation plan of the next best treatments on market, identifying and prioritizing needs and gaps in Canada, developing innovative tactics with key internal stakeholders 2. Project Management: leading operations in interventional and non interventional studies, including primary and secondary use of data, registries, and implementation science research. Scope include local and regional clinical trials, as well as collaborations. 3. Subject Matter Expert for research collaborations: developing local tools and improving processes for the Canadian team to gain agility in collaborating with the best teams across Canada to bring patient-driven solutions to the Canadian Healthcare system
Contractor for Novartis Pharma Medical Affairs - Pharma within Health Research, Data & Partnerships My scope includes a wide range of activities aiming to cover the Health gap across Canada. Proving support to the Medical team, I manage several projects, in order to integrate evidence to Novartis Medical Affairs strategy. This includes interventional and non interventional studies, primary and secondary use of data, health economics modeling, surveys and numerous other solutions. Projects are handled from set up to closure through different activity frame: - Investigator Initiated Trials: main contact for the investigator sponsor, setting contracts and budget with milestones, governance, timelines, drug safety and drug supply - Local trials: full, project and vendor management across Canada and the LatAm region - Research collaborations: collaborating with the best teams across Canada to bring patient-driven solutions to the Canadian Healthcare system
Within a platform of 12 Clinical Vendor Managers, managed through key deliverables Leading vendor management activity for strategic trials within Servier Clinical Operations - Up to 7 international clinical trials concomitantly - Cardiovascular (phase 2) and metabolic (phase 3) diseases, rheumatology (phase 2) and oncology (FIH, phase 1 and 2 including a top priority CAR-T-cells therapy) - Main contact for internal and external stakeholders - Challenging set up of specific biomarker assays, ECG and Imaging central reading and patient monitoring with ePROs: - 12 Request for proposal (RFPs) including scouting of potential new specific vendors, confidentiality agreement, request for proposal, scope of work, proposal evaluation and bid-defense meetings - Study documentation and activity set-up for primary and secondary endpoints according to ICH/GCP guidelines - Method validation, training of monitors and preparation of training material for investigators (IM, SIV) - Review of protocol, ICF, and patient facing materials (eg. ePROs and diaries) - Preparation of documentation for submission to Health Authorities and Ethics Committees (ePRO) - Follow-up of centralized activities: - Logistic support and data management: database cleaning (querying and site support), oversight of data transfers and reconciliations - Budget management and forecasting, invoicing follow-up - Implementation and monitoring of Key Performance Indicators and Key Milestones - Query and sample management - Study closure activities: - Data management: data cleaning on time for study DB lock - Archiving: eTMF and TMF preparation and contribution - Logistics support to sites and local teams Miscellaneous: - Lead of activity-specific meetings (including agenda and minutes) - Problem-solving tasks using a risk management approach including CAPA management - Optimization of process and standard procedure (SOP), mentoring of the team newcomers
6-month extension to my 18-month V.I.E. contract: competitive French program whose goal is to develop young European professionals in an international environment. Missions: 1. Set-up activities of 2 phase-1 studies: a bioequivalence study in diabetes and a phase 1b study in multiple sclerosis: - Monitor, vendors and site trainings: monitoring guide, pharmacy manuals, etc. - Clinical trial application: informed consent form, etc. - Back up in financial activities. 2. Monitoring activities: - Monitoring visits, - Site closure, study initiation visit, etc. 3. Review of publications in oncology and internal communication through posters. Improved skills: - Program management, - Financial activities, - High reactivity and autonomy, - Working in an international team in an international environment.
18-month V.I.E. contract: competitive French program whose goal is to develop young European professionals in an international environment. Missions: 1. Design of early clinical development plans in preclinical projects in food allergy and early infectious disease projects: - Build a clinical strategy, - Connect with external Key Opinion Leaders. 2. Support of biologics programs in translational sciences: e.g. biological sample collections. 3. Report of team's activities to the leadership through team monthly reports. 4. Review of publications in oncology and internal communication through posters. Improved skills: - Program management, - High reactivity and autonomy, - Working in an international team in an international environment.
Global Biotherapeutics Unit - External Sciences & Innovation Team 1. Design of a joint research laboratory between Sanofi and Institut Curie: scientific projects, structure, governance, financing. 2. Scientific and strategic communication
1. Creation of patient’s/GP’s documents such as informed consent forms and patient information sheets according to NRES guidance, clinical trial submissions to Ethics Committees using REC form and SSI forms of the IRAS platform. 2. Operational activities: monitoring visits, clinical study supports, data update. 3. Resource allocation (Pilot). Specific training: - GCP Training: Good Clinical Practice, NHS and ICH E6 Training (August 2013 assessment).