CHRISTINE A. FAIR

San Francisco, CA 650-***-**** ad06ek@r.postjobfree.com linkedin/in/christine-fair LIFE SCIENCES/BIOTECH, MEDICAL DEVICES, AND PHARMA PROGRAM MANAGER & PRODUCT LEADER

q Results-driven, innovative, and energetic executive with sound experience in medical research, product development, and managing complex regulatory approval processes to launch novel drug therapies and medical devices. Excels at meeting project timelines, leading resource planning initiatives, analyzing program risks, building risk mitigation plans, performing contingency planning, and driving operational alignment. q Proven track record of contributing to the advancement of medical technologies and pharmaceuticals, with expertise across multiple areas, including Research and Development, Clinical Trials and Testing, and Product Commercialization. q Demonstrated expertise in implementing quality control measures to maintain product safety, efficacy, and policy compliance throughout all stages of product development processes to support key business partners, including Gilead, Arena Pharmaceuticals/Pfizer, Bayer, Hitachi - DNA Sequencers, Phillips, Baxalta, and Allergan. q Spearheads program planning and execution by actively collaborating with technologists and operations teams to ensure timely delivery on budget.

q Proven success in leading technical teams through product development lifecycle from early-stage research through late-stage clinical development to commercialization in fast-paced, changing environments. Remarkable acumen to oversee multiple tasks, work effectively under pressure, lead cross - functional teams, and meet tight deadlines. CORE SKILLS AND COMPETENCIES

• Medical Device & Product Development

• Strategic Planning & Execution

• Drug Development and Manufacturing

• Regulatory Compliance

• Project and Alliance Management

• Team Building & Leadership

• Quality Control and Assurance

• Clinical Operations

• Complex Problem Solving

• Cross-Functional Collaboration

• Process Optimization

• Relationship Management

SELECTED CAREER ACHIEVEMENTS

§ HUYABIO INTERNATIONAL − Guaranteed efficient and timely communication between functions and senior management on issues and interdependencies, including budget and resource constraints.

§ SECOND GENOME – Led a highly skilled team of Technical Program Leads through drug discovery and early development to regulatory filing, such as developing program plans, budgets, and performance metrics.

§ TAKEDA (FORMERLY SHIRE PHARMACEUTICALS) – Spearheaded the development of medical devices in compliance with FDA Title 21 DFR part 820 regulations that included prefilled syringes, auto-injectors, and diagnostic monitor devices for variable dosing applications in adults and pediatrics. PROFESSIONAL EXPERIENCE

HUYABIO INTERNATIONAL, SAN DIEGO, CA (Oct 2022 to Aug 2023) Vice President, Program Management

Presented thoughtful oversight and leadership to support a highly talented team of 4 program managers overseeing a clinical portfolio for oncology and cardiovascular therapies with a $65M budget. Defined and monitored key performance indicators (KPIs) to assess program success and make data-driven decisions.

§ Acted as Chief of Staff to Executive Vice President of Clinical Development and Medical Affairs.

§ Monitored activities with external business partners and alliances to meet partnership contract deliverables.

§ Provided regular updates and reports to senior leadership, stakeholders, and board members influencing future business decisions.

§ Oversaw advancements of R&D and Clinical corporate objectives, prioritized concurrent program and departmental requirements, managed correspondence with the Board and investment partners, formulated meeting agendas, composed meeting summaries, and conducted critical program discussions to address challenges and steer data- informed decision-making.

CELLULAR LONGEVITY, INC., DBA LOYAL, SAN FRANCISCO, CA (Jun 2022 to Sep 2022) Vice President, Program and Portfolio Management

Developed and executed strategic plans to develop and launch the company's programs and portfolios in alignment with organizational goals and objectives. Presented program leadership for pipeline programs, early-stage R&D, and clinical corporate goals. Fostered collaboration between different departments and internal teams to drive organizational alignment and synergy across various programs and projects.

§ Built program development plans, developed cross-functional team structures, managed Board communications, created fully integrated program schedules, led critical program discussions, and monitored program budgets to influence major data-driven decisions.

§ Consistently met targeted program milestones and deliverables. SECOND GENOME, SOUTH SAN FRANCISCO, CA (Apr 2020 to Jun 2022) Vice President, Operations, Program, Alliance and Portfolio Management Created and implemented R&D operational functions to align program plans with corporate goals and objectives as well as day-to-day planning, coordinating, and tracking of critical R&D activities. Facilitated program strategy and maintained accountability of program execution across the portfolio.

§ Delivered valuable support to Chief Operating Officer and Chief Scientific Officer to optimize the value of strategic alliances and business partnerships, attaining successful execution of business strategies and operational goals.

§ Partnered with CFO and Controller to transition finance system to FP&A organizational structure, integrating program schedules, streamlining program spending efforts, and mitigating potential risks.

§ Ensured external partners, collaborators, contractors, consultants, and CROs upheld contractual obligations, including generating scientific data, resourcing, finances, timelines, reports, and information-sharing disclosures.

§ Applied R&D operational functions to develop and refine program plans and budgets.

§ Set key performance indicators and created timelines for driving internal and external programs on schedule. TAKEDA (FORMERLY SHIRE PHARMACEUTICALS), CAMBRIDGE, MA (Mar 2016 to Dec 2019) Executive Director, Global Program Management, Medical Devices & Combination Products Spearheaded a high-performing team of 10 program managers supporting drug/device combination product and medical device teams through product development lifecycles. Created robust alliances between Commercial Product Strategy Teams, Finance, Regulatory, Quality, Global Clinical Development, and Operations.

§ Introduced digital mobile applications in 40 countries to support Hematology therapies to create a positive impact on patient care and treatment management.

§ Designed, tested, and deployed personalized devices for at-home IV infusion systems, implantable devices, wearable infusion pumps, and precision medicine applications for novel drug therapies, optimizing drug development processes to reduce time-to-market efforts.

§ Spearheaded successful product launches, featuring Natpara Injector Pen to treat Hypoparathyroidism and myPKFit Digital Applications to treat hemophilia, Intrathecal drug delivery device platform to treat Hunter Syndrome and Metachromatic Leukodystrophy (MLD) during Phase 3 clinical studies.

§ Examined alternative routes of delivery for rare disease therapies to improve effectiveness and patient experience in treating rare diseases.

§ Generated more than 50% of Shire revenue supported by medical devices successfully. PHILIPS HEALTHCARE, CAMBRIDGE, MA (Jul 2015 to Mar 2016) Senior Director, Regulatory Program Management

Administered Premarket Approval Submissions to FDA for Emergency Care and Resuscitation business.

§ Evaluated potential regulatory risks and advised senior management on strategies to mitigate them effectively.

§ Maintained effective communication with regulatory authorities, addressing inquiries and representing the company's interests during regulatory inspections and audits.

§ Ensured that programs and projects adhered to relevant regulatory requirements and quality standards. BIOMARIN PHARMACEUTICALS, INC., SAN RAFAEL, CA (Dec 2014 to Jul 2015) Consultant, Program Management, Clinical Development Sciences Operations Oversaw budget allocation and resource planning for clinical programs, ensuring efficient utilization of resources. Developed and implemented effective program strategies that supported the overall clinical development goals and objectives of the company.

§ Enhanced business processes and championed change management initiatives, supporting product teams and clinical operations teams.

§ Optimized program team resources by partnering with key leads from the Clinical Operations, Contract Research Organizations (CROs), Registered Nurses (RNs), and Program Managers to achieve targeted goals, monitor Key Performance Indicators (KPIs), and spearhead Product Development initiatives. Early Career

Director, Program Management · Global R&D Portfolio, Program Management and Finance – Allergan Medical, Santa Barbara, CA / Raindance Technologies, Lexington, MA Senior Program Manager – Thoratec Corporation, Pleasanton, CA / Life Technologies (Formerly Applied Biosystems), Foster City, CA

EDUCATION

Master of Science (M.S.), Biology (Physiology and Behavioral Biology) SAN FRANCISCO STATE UNIVERSITY, SAN FRANCISCO, CA THESIS: EXCITABILITY OF A PEPTIDERGIC NEURAL SYSTEM IN THE MARINE MOLLUSK, APLYSIA RESEARCH: DR. EARL MAYERI, DEPT OF NEUROSCIENCE, UNIVERSITY OF CALIFORNIA - SAN FRANCISCO Bachelor of Science (B.S.), Electrical Engineering SAINT CLOUD STATE UNIVERSITY, ST. CLOUD, MN Medical Degree Coursework ST. GEORGE’S UNIVERSITY SCHOOL OF MEDICINE, WEST INDIES CERTIFICATIONS AND PROFESSIONAL DEVELOPMENT

Drug Development: Biopharmaceutical Research & Development, Pharmaceutical Education, Boston, MA Medical Device Regulations: Medicinal Products/ Drugs EU regulations meet FDA Medical Devices, Barcelona, Spain Stanford University Executive Management Program: Marketing Strategy for Technology-Based Companies, Stanford, CA Medical Science Courses: St. George’s University School of Medicine, Grenada, West Indies Surgery Clinical Rotation: San Joaquin General Hospital Stockton, CA Anatomy Selective: University of Alabama School of Medicine, Birmingham, AL Project Management Instructor: Certification and Project Management Professional, PMP New England BioLabs Molecular Biology Intensive Research Workshop: Smith College, Northampton, MA Population Genetics Statistical Analysis for Forensics Scientists: Applied Biosystems, Foster City, CA

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