Juan Hernandez
Irvine,CA
Summary
Drug Development Professional with over 25 years of progressive leadership and general management experience leading multidisciplinary programs involving Phase 1-4 clinical trials. In clinical development operations achieved a successful track record of leading and managing global development teams from IND to early and late development and to post-market approval trials. Direct experience in preparation of INDs and BLA/NDAs marked by contributions to the following marketed products: Ajovy, Dalvance, Zometa, Vectibix, Nexavar, and Cymbalta Leadership: Proven record of leading high-performing clinical teams through the development value chain Excellent communicator, skilled at being direct and diplomatic, while combining science and business Governance experience in a range of organizational environments from start-up to mid-size to mature
Overview
31
31
years of professional experience
Work History
Consultant
Pharmacon Group, Inc
01.2021 - Current
- To various start-ups and venture firms (Clinical Operations, Lead and Head, Data
- Management)
- Operational strategy and end-to-end management of complex, early-stage, FIH (adaptive design)
- Development of protocols, ICFS, IBs, CRFs, TLFs, CSRs, and manuscripts, budget management
- Lead and manage all data informatics inclusive of EDC build oversight, RTSM, eCRFs, PK, and TLFs
- Manage all aspects of the clinical trial(s), including assessing operational feasibility
- Management of comprehensive study timelines and metrics; lead selection and management/oversight of external vendors and developed vendor specifications, reviews of vendor reports, budgets, and metrics
- Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepare and present project debriefings on a regular basis
- Lead cross functional IND team comprised of Clinical Development, Statistics, PK, Medical Sciences
- Regulatory, Toxicology, Safety Management, and Pharmaceutical Sciences/CMC
- Manage key cross-functional strategic R&D projects sponsored by client and VCs, including CMOs
- CROs, and PV Vendors, including budgeting and capacity management
Vice President
NCGS, Inc
01.2011 - 01.2021
- Clinical Operations & Implementation
- Accountable for the business operations of the study start-up and feasibility, including planning, developing, leading, and managing business strategy, resources, budget and corp
- Goal settings
- Drive the optimization of implementation, resource management, organization, and decision making
- Lead key strategic initiatives and management of clinical operations, clinical systems: CTMS, TMF
- EDC, pharmacovigilance, contract/site payments
- Regulatory, medical writing, quality, and publishing
- Ensured high compliance with company SOPs, ICH/GCP guidelines, governing regulations, and patient safety standards, in order to maintain site inspection readiness
- Drop preparation and facilitation of bid defense meetings and serve as subject matter expert
- Manage traditional project management deliverables such as: MS Project schedules, team agendas and minutes, team budget summaries, team chartering (DACI) and project chronology
- Design and implement global project management framework & processes, including creating a strategic project planning template and project dashboard to facilitate peak team performance
Vice President
Amunix Pharmaceuticals
01.2009 - 01.2011
- Clinical Project Management
- Leadership of strategic operational guidance to ensure clinical programs are properly defined, planned, and executed across all clinical stage programs for various therapeutic modalities
- Lead review and finalization of all site contracts, NDAs, vendor contracts, including CRO and CMO
- Manage traditional project management deliverables such as: MS project schedules, team agendas, and minutes, program budget summaries, chartering (DACI) and project FAQ and chronology
- Design and implement global project framework, including program dashboards and KPIs
Global Program Team Director
Novartis Pharmaceuticals, Inc
01.2007 - 01.2009
- Trophy for Zometa brand being a top-performer at ASCO 2008
- Lead global enterprise and strategic initiative to optimize planning, budgeting and finance functions
- Guided development and piloting of “Program Management Dashboard” which serves as the primary real-time source of information for the CEO, Executive Committee, and Portfolio Management
- Key Outputs:
- Lead strategic direction of Oncology Bone Franchise (1.8B asset) and second-generation products
- Created clinical reporting team which identified country specific opportunities to improve trial planning accuracy across the portfolio - site startup durations improved by 20% within 12 months
- Deputized as Global Head of Oncology Clinical Development programs (phase 0 to 5)
- Accountable for Zometa presented at governance boards, safety review boards and Labeling
- Lead cross-functional teams in the detailed assessment of viability of selected BD&L opportunities, performed due diligence and present business case for primary candidates to senior management
- Contribute to and support safety aspects of product clinical development programs including conduct of safety-focused phase 4 study commitments
- Oversee the process for the development and tracking of the yearly corporate goals and contracts
Sr
Amgen, Inc
01.2003 - 01.2007
- PM, Oncology Program Management & Strategic Operations
- Key Highlights:
- Lead and integrate regulatory BLA filings for Amgen’s 1st
- Oncology Therapeutic program-Vectibix
- Awarded the “Most Strategic” team for 2004 by the R&D Executive Committee
- Accorded the “Hall of Fame” trophy by the Marketing Leadership Council for piloting commercial launch framework for AMG 954 and developing the “Commercial Playbook”
- Key Outputs:
- Lead and drive all aspects of AMG 949 & 429 PST, including development of the Global Strategic
- Plan (GSP), in order to provide downstream tactical direction to the following teams: Commercial
- Medical Affairs, Research, Clinical Operations & Quality, and Regulatory, Medical Safety
- Manage multidisciplinary team to define goals, scope, schedule, and resources for the programs and communicate progress and key program risks and mitigation strategies to Senior Management
- Triage and manage PM participation in due diligence reviews for co-development partner evaluation, including review of joint development plans with Licensing and Alliance Management
- Drive strategic discussions and serve as cross-functional “devil’s advocate” for ensuring all views are heard, all new strategic opportunities are capitalized, and any potential threats are minimized
- Lead presentation of strategic / tactical plans to Executive Review Boards & Pipeline Committees
Clinical Program Leader
Onyx Pharmaceuticals, Inc
01.2001 - 01.2003
- Oncology Development
- Participated in oversight of unscheduled FDA inspection of Onyx facilities by providing updates to the
- Leadership team - I was personally thanked by the CEO for my effectiveness and professionalism and received “Recognition for Extraordinary Contribution” Award
- Co-Led the product team to go/no-go decision points for multiple indications of lead candidate
- Drove the operations and execution of development plans for two clinical candidates
- Managed a team of CRAs and coordinators, and ensured team complied to ICH/GCP standards
- Managed CRO, PV alliances, and Vendors, and ensured the tracking of milestones and deliverables
Director
Omnicare, Inc
01.1998 - 01.2001
- Clinical Trial Management
- Managed Phase I, II and III multi-center clinical trials of various therapeutic modalities, including protocol development, safety assessments and initial data analysis
- Hired and trained several CRAs, including administration of performance appraisals and development plans
- Compressed the Cymbalta (2nd generation entity) development timelines by 3 months, resulting in submission of the NDA earlier, thereby minimizing patent cliff expiration of PROZAC
- Acquired “Preferred Provider” status from a pharmaceutical firm with a 400M annual outsourcing budget as a result of presenting the Company’s full-service capabilities
- Selected to business development swat-team due to successes in presenting, negotiating, and closing bids, resulting in an increase of RFP wins by 25 percent
- Participated in the development and implementation of the Global Project Management Process (GPMP), which captures the projects key deliverables and milestones
Sr. Clinical Trial Manager
CoCensys, Inc
01.1997 - 01.1998
- Clinical Development
- Management of CNS development activities for Ganaxolone programs in multiple indications, including IND preparation
- Accountable for hiring, mentoring, training, and directing CRAs to conduct development activities per cGCP and ICH guidelines
Cell Therapy Specialist III
Rhone Poulenc Rorer, Inc
01.1994 - 01.1997
- Division
- Cell technologist performing cell manipulation (TIL+ Proleukin) for RCC, PCa, MM
- Lead transfer of novel technologies from institutions and companies, validation of procedures and equipment, training of Cell Specialist and writing of Standard Operating procedures using current GLP and GMP (tissue)
Research Scientist
University of Southern California, Keck School of Medicine
01.1993 - 01.1994
- Primary focus was translational-type of research to devise novel therapy strategies for neonatal lung development
- Proficient with molecular biology and biochemistry experimental techniques, including flow cytometry, ELISAs, IHC, and PCR
- Responsible for all clinical lab equipment trouble-shooting
Education
Bachelor of Science - Biology and Chemistry
Chapman University
Orange, CADegree - Engineering Technology
Don Bosco College of Science And Technology
Rosemead, CA05.1985
Certificate in Project Management (focus in Pharmaceutical Industry -
University of Colorado
Skills
- Problem-Solving
- Attention to Detail
- Team Leadership & Development
- Client Relationships
Timeline
Consultant
Pharmacon Group, Inc
01.2021 - Current
Vice President
NCGS, Inc
01.2011 - 01.2021
Vice President
Amunix Pharmaceuticals
01.2009 - 01.2011
Global Program Team Director
Novartis Pharmaceuticals, Inc
01.2007 - 01.2009
Sr
Amgen, Inc
01.2003 - 01.2007
Clinical Program Leader
Onyx Pharmaceuticals, Inc
01.2001 - 01.2003
Director
Omnicare, Inc
01.1998 - 01.2001
Sr. Clinical Trial Manager
CoCensys, Inc
01.1997 - 01.1998
Cell Therapy Specialist III
Rhone Poulenc Rorer, Inc
01.1994 - 01.1997
Research Scientist
University of Southern California, Keck School of Medicine
01.1993 - 01.1994
Bachelor of Science - Biology and Chemistry
Chapman University
Degree - Engineering Technology
Don Bosco College of Science And Technology
Certificate in Project Management (focus in Pharmaceutical Industry -
University of Colorado