Medical Management

HELEN LEIGH SHOCRYLAS

**********@*****.***

Southborough, MA, 01772 (c) 508-***-****/ (h) 508-***-****

PROFESSIONAL SUMMARY

Self-motivated, independent, and adaptive professional with 10+ years experience within the global pharmaceutical industry, with extensive experience in complex project management and global cross-functional team collaboration associated with Research, Clinical Development, Clinical Trials (Phases I, II, III, IV), Regulatory Affairs, Translational Medicine, Pharmacovigilence, across diverse therapeutic fields the within healthcare, pharmaceutical, and biotech industries. Adept aptitude for facilitation of: Global Leadership teams, FDA communications and logistics, venture capital and investor relations, scientific collaborations, patient advocacy, product public relations, media relations, business development, international markets and finance, legal affairs – corporate and clinical, academic/scientific alliances, partnerships, IP and patents, international visas, and Regulatory/Clinical Trial compliance. Optimistic focus in Oncology, with the conviction that my motivated efforts and contributions will make an impact towards a cure.

CORE COMPETENCIES

Project/program management IND, NDA, BLA, MA, PMA, 510(k) FDA, 21 CFR & ICH regulations

Cross-functional team integration Exemplary writing & communication skills Strong scientific acumen

CRC & CRA training R&D, Clinical Research, Medical Affairs EMA, WHO, & Health Canada

Biostatistics/Adaptive Trial Design Oncology, CNS, GI, Vaccines, ADC’s IRB’s, FDA meetings, Ad Boards

Trial Registration & Protocols Medical Devices & Companion Diagnostics International Regulatory Affairs

EDC, Trial Master Files, Data Lock GI Oncology, Helicobacter, H-pylori RA CMC, Submissions (eCTD),

Budgeting, Contracts, Legal, Visas NIH, NCI, NIDA, and Private Grants Strategy, Labeling & Promotions

PROFESSIONAL EXPERIENCE

2011 to Present Takeda Pharmaceuticals International Cambridge, MA

Biostatistics & Analytical Science, Coordination/Program Management (Jan. 2014 – Present)

Global team coordination/ program management for VP, Global Biostatistics and Programming – Oncology, Innovation & Consultation, CVM, CNS/ Immunology, GI & Phase I, Vaccines, Innovation & Consultation (Biomarkers and Translational Medicine) (Cambridge, Chicago, San Diego, London, Japan, China, Singapore, Zurich, and Copenhagen)

Manage new Takeda global Biostatistics/Analytical Science internal business channels, work streams, seminars, collaborations, team building, training/development, academic relations, and guest-speaker events across all therapeutic areas optimizing global team functioning

Coordinate consultants and academic speakers for Biostatistics Biomarkers/Translational Medicine Innovation Initiative

Coordinate inter-departmental meetings for global Biostats leadership: Governance, ODRC, Clinical Research, Development & Operations, Statistics, QA-Compliance, and Regulatory, given integral knowledge of team interdependence, program requirements, and corporate goals

Manage departmental financials for all events: Quarterly Global Teambuilding, Annual Biostatistics Summit, Biostatistics & Programming Events, Special Speaker Seminars

Departmental Contract Documentation Associate (CDA): manage contracts with vendors, contractors, special speakers, and consultants, including payments, tracking financials and resources

Manage international visa requirements for department biostatisticians – China, Taiwan, India, and Japan

Project/Program support and team participation, as required

Extensive knowledge of electronic documentation systems and regulatory requirements – (eCTD, ClinicalTrial.gov)

Additional Coordination Responsibilities – Global Restructuring (2015 – Present)

Informatics and Genomics, SVP of Informatics and Genomics

Global Medical Organization, Global Medical Officer – when in TBOS

Regulatory Affairs Administration/Coordination (Oct. 2011 – 2014)

Global team coordination for new Takeda Regulatory Leadership initiative: management and facilitation for Global Regulatory Submissions and Operations, Global Regulatory Publishing, and Global Regulatory Labeling – prioritizing/developing new global business channels, work streams, external relations for Boston, London, Chicago, and Japan.

Project support for RA Leadership Team: Regulatory CMC, International, Labeling & Promotions, and Submission

Information Operations and Management: monthly RA portfolio dashboards, translation documentation from LOC’s, fees for international health organizations, government organizations, KOLs (Sunshine Act compliance)

Coordinate special events logistics: FDA Briefing Meetings, seminars, global Takeda meetings, Ad Boards, Clinical Research meetings.

Project manager for monthly RA briefing book of dashboards for RA Leadership, Project Review meetings, GAP analyses metrics for RA training, ensure compliance with clinical trial disclosure and trial protocols/deviations for ClinicalTrials.gov, RA project assignments for Millennium portfolio, confidential FDA inter- and cross-departmental activities

Management of Regulatory Vendor/CRO/CRM contracts, payments, SOW’s, amendments, CDA’s, legal review, conflicts of interest disclosures, contracted FDA consultants, Health Authority fees and international banking requirements

Team member for Regulatory Submissions & Operations compliance oversight – change and rewrite of SOP’s/BP’s, deviations, archiving, tracking and reporting compliance with Corporate and FDA-mandated training

Coordinate FDA meetings, logistics, mock meetings, briefing books, contracts for CMC Regulatory meetings with FDA for IND/NDA submissions, conference logistics for international offices and global affiliates worldwide

Coordinate CTAs and MAAs for European Health Authorities and INDs, NDAs, and BLAs for FDA

Management of Regulatory Affairs visa requirements and International Regulatory documentation translations – ensure official validation, verification, signature, and fees/payments for global Regulatory LOC’s.

2010 to 2011 Sanofi-Aventis Cambridge, MA

Program Coordination/Management, Early Development Oncology Portfolio

Coordinate Early Development & Pre-Clinical projects, meetings, and international group conferences fostering cross-functional integration with Discovery, Translational Medicine, Bioinformatics/Biostatistics, and Clinical Development for the Senior Director of Early Development Oncology Portfolio

Coordinate MIT/Sanofi new alliance & partnership initiatives for Scientific Planning Committee with MIT scientific investigators, associated meetings, corporate grants for academic investigators

Organize domestic/ global team meetings and conference logistics for Clinical Development Directors and Medical Directors for clinical trials in all Phases I, II, III across 11 programs in target portfolio

Executive support and program initiation of lab start-up for Section Head, Cancer Biology to establish functional oncology laboratory unit requiring proficient written and oral French language communications.

Manage extensive and multifaceted global logistics for various Medical Affairs Advisory Board meetings

Coordinated clinical trial site explorative visits for Early Development, Translational Medicine, and Clinical Operations by overseeing Regional Medical Liaison and clinical site personnel initiatives

2009 to 2010 Abraxis Bioscience Burlington, MA

Administrative Management

Managed initial start-up operations and business channels for a 17 member new biotech startup

Managed global corporate events, meeting logistics for Executive Leadership (R&D, Clinical Operations, Program Managements, and Finance) venture capital engagements, partnership/licensing, Medical Affairs Ad Boards, and external academic collaborations.

Managed consulting, clinical contracts, and licensing agreements, and contractor and vendor payments

Wrote employee press biographies

2008 to 2009 Massachusetts Institute of Technology Cambridge, MA

Executive Coordinator to the Director, Division of Comparative Medicine – Gastrointestinal Oncology Research

Grant preparation and submission for DCM/NIH, NCI grants, abstracts, manuscripts, and journal reviews – extensive collaborations with global academic institutions, private and governmental organizations.

Program manager: Fellowship program and Post-doc programs (186 member lab)

Manuscript preparation/editing, and electronic submission of DCM scientific manuscripts to journals, payments, reprints, researching, retrieving supporting documentation, research material, author releases.

Manage DCM academic programs and internal/external seminars: logistics, coordination, collaboration, advertisement and promotion.

Coordinate team meetings with DCM, Whitehead Institute, Broad, MIT President and Provost, MIT Scientific Alliances, internal collaborations with various MIT science departments.

Coordinate IRB meetings (both internal/external), facility tours, meeting schedules, and associated research documentation, and animal research compliance (IACUC).

2007 to 2008 Northeastern University Boston, MA

Executive Coordinator to the Director, Center for Drugs Discovery (CDD)

Development officer for CDD: Public Relations, External Alliances, Licensing, Global Academic and Medical organizations, NEU internal publicity and promotion

Managed peer review engagements with NIH, NCI, and NIDA, logistics and promo for CDD seminars, conferences, and NEU mentoring programs (both internal/external)

Program manager for Fellowship programs and for graduate, post-doctoral, and research academic applications process, and thesis dissertations.

Managed domestic/ international scientific promotional events, including logistical support – Cyprus, Greece, Switzerland, France, Germany

Managed NIH, NIDA, and NCI grants and related grant activity – preparation, editing, budget, and submission

Managed scientific manuscript preparation and submission for scientific journal publication

SUPPORTING PROFESSIONAL EXPERIENCE

Canadian & British Consulates General, Boston, MA

INTERNATIONAL TRADE MANAGEMENT – Business Development & Trade, NAFTA, Diplomatic Events

Telefilm Canada

MARKETING MANAGEMENT – Foreign & Domestic Markets, Broadcast & Feature Film Fund – American Academy Awards (Oscars), Cannes Film Festival, Sundance Film Festival, Toronto International Film Festival (TIFF)

Canadian Broadcasting Corporation (CBC)

PROGRAM RESEARCH – CBC News, Hockey Night in Canada, The Nature of Things, The Fifth Estate, Second City TV

EDUCATION

John’s Hopkins University, Baltimore, MD MS, Regulatory Science – Currently enrolled online

Foundations in Bioscience Translational Biotechnology: Intellectual Property to Licensing

Biological Processes in Regulatory Affairs Clinical Development of Drugs and Biologics (GCP, Strategy, Pathways)

International Regulatory Affairs cGMP Compliance (QMS, CAPA and Risk Management)

Medical Devices & Companion Diagnostics Regulatory Strategies FDA Law

Worcester State University, Worcester, MA MS, Communication Disorders, Clinical Fellowship incomplete

Neurological Disorders Cognition and Cognitive Disorders Degenerative Disease

Diagnostics and testing Research Design Chemistry

Clinical Writing and Practice Anatomy Biology

Audiology Dysphagia & Swallowing Disorders Phonological Processes & Disorders

University of Western Ontario, Canada BA, Honors, English and Classical Studies

LANGUAGES

Proficient in French

SKILLS

SharePoint, Project, Excel (Macros), PowerPoint, Adobe, Galaxy, End Note, SAP, Visio, Photo Shop

ORGANIZATIONS

PMC – Personalized Medicine Coalition

AACR – American Association of Cancer Research

ASHA – American Speech, Language & Hearing Association

Takeda Ambassador for Healthcare Business Association – Boston Chapter (HBA)

Takeda Volunteer Initiatives: Corporate Communications, Systems Integration Focus Group, Learning & Development Team, and Patient Advocacy

Active in various philanthropic volunteer initiatives

Worked in Hong Kong and traveled extensively throughout East Asia

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