Michael Torok, Ph.D. Email & Phone Number

Switzerland 🇨🇭, CH

• I lead Roche's Quality Assurance Programs team responsible for the design and delivery of Quality Assurance strategies, risk and issue management, and delivery of quality evidence for our new therapeutics. Focus areas.
• Delivering meaningful evidence to support Quality Briefs for new therapeutics based on Impact/Critical to Quality factors that underwrite patient protection & result reliability.
• Driving the Quality Brief paradigm shift aimed at increasing Health Authority confidence in quality assurance practices across new therapeutics.
• Using advanced analytics tools to identify, monitor, and manage risk and issue signals across development of new therapeutics. Serve as Deputy-Director on the IMPALA (IntercoMPany quALity Analytics) consortium.
• Enhancing our Culture of Quality, across Global Develop, in line with the ICH E8(R1) renovation and developing tomorrow's quality professionals
• Serve as the GCP Council Chair for Roche Medical Compliance Outside of Roche, I serve as a member of the DIA's Annual Planning Committee (2025-2027) and a member of CTTI project "Ensuring Data Quality Within More.

• I led Astellas' Clinical Quality Assurance teams responsible for Process Improvement, Operational Excellence, and Clinical Quality Audits.Projects and focus areas were:
• Process agility and change management, working with stakeholders to implement innovative ways of assuring quality
• Using advanced analytics and machine learning to identify, monitor, and manage risk and issue signals across clinical projects, processes, and inspection readiness. Represented Astellas within the IMPALA (IntercoMPany.
• Risk-based audit strategy and appropriately leveraging remote data sources and analytics
• Enhancing our Culture of Quality in line with the ICH E8(R1) renovation
• Developing tomorrow's quality professionals and Learning Communities

• Redesigned the Clinical Quality Lead role at Astellas. The updated role focuses on the following: 1) animating ICH E6(R2) Quality by Design principles to build effective investigational plans (study protocols and all.
• Provided ongoing expertise to clinical operations teams for Quality by Design, Risk Based Monitoring, Risk Assessment and Categorization Tool, Quality Tolerance Limits, Key Risk Indications, Proactive Risk Assessments.
• Provided QA-based leadership and strategic direction in support and oversight of Medical & Development (M&D) clinical trials (Phase I-IV) to ensure compliance with GCP and international regulatory requirements.
• Awarded Astellas Medical & Development Functional Award for helping develop "A Global, Cross-Functional Initiative to Drive Operational Excellence Through Consistent Delivery, High Quality and Oversight of Clinical.

• Ensured CPED clinical studies and strategic initiatives were successfully executed and met/exceeded corporate objectives across oncology, CNS/pain, urology/nephrology, and frontier diseases therapeutic areas.
• Redesigned components of R&D outsourcing model focused on enhancing value in sponsor and CRO project delivery (PhI-IV), subject safety, data integrity, oversight, and inspection readiness.
• Harmonized Operational processes, systems, and tools between the Americas, European, and Asia Pacific R&D groups.
• Designed Project Management system using Planisware/Tableau for clinical development timelines, costs, and resource forecasting and reporting. Integrating descriptive and predictive analytics to drive operational.
• Mentored, coached, and developed Director-level reports; I focused on an overarching theme of strategy, empowerment, and accountability.
• Awarded 2015 VISION award for developing global environment for operational planning and managing clinical projects. Team created 18 standard study types (SAD, MAD, DDI, FE, etc.) which enable prospective forecasting.

• While serving as Head of Operations in CPED, asked to take over C&O department on temporary basis. Oversaw contracting, strategic sourcing, vendor management, and transition work (addressing urgent inspection readiness.
• Completed department diagnostic focused on team dynamics, contracting status, business partnering, operational risks, strategic sourcing, and vendor management.
• Effectively addressed contracting delays for pivotal studies of Astellas’ top oncology assets. Ultimately, study contracts were delivered (106% and 194%) ahead of time.
• Stabilized areas of department risk – initiated audits, launched CAPA activities to address gaps, and closed out multiple CAPAs.
• Launched initiatives to strengthen the department: 1) Clinical study start up task force to prospectively identify and address contract inefficiencies, 2) Initiated process harmonization with Japan R&D to drive.
• Developed supplier information, and workflow process, for Astellas strategic sourcing efforts – included vendor qualifications, contract status, and Astellas work history.

• Directed business operations focused on project execution, optimizing efficiencies, and driving strategic partnership value across 25 compounds. Responsibilities quickly expanded to serving as line manager for all CPED.
• Led CPED contributions on Astellas-wide efficiency initiatives including Fast-to-Proof of Concept, metrics augmentation, and process harmonization.
• Led preferred provider and strategic partner outsourcing strategies, governance models, and served as Executive Steering Committee member for multiple strategic relationships. Ensured outsourced activities were.
• Oversaw development of Operations staff in current and “future-state” scenarios, capacity planning, and recruitment and retention.
• Leveraged my early and late phase experience while serving on Astellas’ Transcelerate working groups.

Durham, North Carolina, US

• Accountable for the successful delivery of Specialty Care business unit (SCBU) for PAREXEL’s top account. The SCBU executed 40 PhII-IV clinical studies (11 compounds) across 55 countries with $375M+ in services. Due to.
• Chaired account-wide, weekly operations teleconferences for 200+ Project Leaders and Directors, SMEs, and other Portfolio Directors. Served as Point-of-Contact for account consisting of 2,300 head count (1,281 FTEs).
• Oversaw North and South American operational governance; led unification of compliance processes across the EU, APAC, and Americas regions with focus on patient safety, data integrity, and inspection readiness.
• Oversaw Quality and Risk activities with portfolio wide tracking of quality standards, trends analyses and mitigation efforts, as well as audit and inspection preparedness efforts and responses.
• Accountable for financial oversight including FTE forecasts, margin enhancement, asset and program level new business awards, change order management, and BU invoicing.
• Part of Executive team awarded “Partnership Pioneers of the Year Award” from the Institute for International Research and Partnerships in Clinical trials, April, 2013.

Durham, North Carolina, US

• Directed phase IIIb and IV, peri-approval, label expansion, safety surveillance, expanded access, and post-marketing commitment clinical studies in over 35 countries. Responsible for overall program operations and.
• Effectively directed matrix teams across 8 rescued studies - all successfully transitioned on or ahead of schedule. Leveraging my strong relationship with the sponsor, additional studies were non-competitively awarded..
• Co-chaired asset-level project reviews with sponsor clinical heads, asset leads, and business units. Served as main point of escalation for sponsor and PAREXEL upper management.
• Directed program wide metrics reporting on project lifecycle, risk mitigation, budget analysis, revenue and labor forecasting. Streamlined program level processes creating team efficiencies, harmonized processes, and.
• Appointed Subject Matter Expert of Project Director onboarding and training. Mentored Project Leaders and Managers across 4 assets.

Raleigh, North Carolina, US

• Managed full service Ph II-III clinical studies in oncology, CNS, and respiratory indications. Most recent global studies completed enrollment 14 and 4, months early. Results driven achievements consistently lead to.
• Resolved 10+ escalations/week, and served as single point-of-contact to PRA Senior Vice Presidents and General Partners.
• Created multiple risk analysis, project, budgetary, and resource allocation plans. Consistently increased study margins by creating efficiencies and supporting under-performing personnel. Created multiple team training.
• Co-created, championed, and executed numerous process improvements incorporating sponsor-facing databases, biosample processing and tracking, vendor management, and TMF quality programs.
• Mentored study start up, clinical operations, monitoring, and business development teams.
• Awarded ACRP, Project Management, and New Business Awards and Bonuses.

Raleigh, North Carolina, US

Raleigh, North Carolina, US

Charlottesville, Virginia, US

• Operations and Strategy leader for asset development of 2 drug candidates, and pharmacogenomic, multi-variable assay for alcohol abuse and dependency. In July, 2018, ADial successfully completed it's IPO.
• Directed operations execution across IP estate, CMC and life-cycle management, regulatory requirements and FDA meetings, and expansion of drug candidate portfolio.
• Co-led business development negotiations across strategic partners, the University of Virginia Patent Foundation, and multiple CRO vendors.
• Co-led multiple capital raise rounds, and recruited top-flight Board of Directors and Executive Team management.
• Progressively promoted for exemplary achievements: Consultant, Chief Operating Officer, and Chief Executive Officer and Director.

• Led scientific team which created novel-automatable cell culture assays yielding a 4-fold reduction on costs and work hours. Several laboratories currently utilize this new, cGMP, technology which in 2009 was voted a.
• Managed scientific team, R&D vision, project budgets, and patent enablement processes. Scientific team applied for multiple patent applications.
• Awarded 2nd prize at the University of Virginia, Darden School of Business, Business Plan competition.
• Awarded 3rd prize by the Association of Laboratory Automation for project entitled “Automated Bioreactor Based Microcarrier Cell Culture.”

Charlottesville, VA, US

• Worked closely with faculty members wanting to create IP protection, and potential corporations, around their oncology, CNS, and CV disease related technologies.
• Supported faculty inventors in preparing invention disclosure packets, CDAs/NDAs, term sheets, and patent applications
• Supported faculty in exploring corporate structure, governance, university policies, IP nationalization, and strategic partnerships.
• Reviewed startup business plans, SBIR and STTR grant proposals, technology licenses
• Contributed to state of Virginia’s Center for Innovative Technologies-award winning Spinner Technologies infrastructure grant and the Spinner Technologies Entrepreneurial Workbook.

Knoxville, Tennessee, US

Worked in Laser Center assisting clinical research team collect endoscopy data from patients with Barrett’s esophagus, or late stage esophageal cancers, being treated with a combination of photo-activated drugs and balloon photodynamic therapy.

Knoxville, Tennessee, US

Worked full time as a Patient Care Assistant under the direction of Department Chief and Unit Leader; conducted vitals, catheterized patients, removed sutures and staples, applied orthoglass splits, gave CPR, and assisted with reducing fractures, cracking chests, responding to life-flights, pumping stomachs, and managing drug seeking patients and those.

Certificate, Data Analytics For Business Professionals

Ph.D., Biochemistry And Molecular Genetics

Master Of Science (M.S.), Biological And Physical Sciences

B.S., Honors Microbiology