Mark A. Lanfear

Mark A. Lanfear Email and Phone Number

Chief Solutions Officer | FSP - Workforce Solution Architect | Global Staffing & Recruitment Leader | Biopharmaceutical R&D SME | Regulatory Affairs Professional | Certified Clinical Research Associate @ Proclinical Group
Detroit, Michigan, United States
Mark A. Lanfear's Location
Detroit Metropolitan Area, United States, United States
Mark A. Lanfear's Contact Details
About Mark A. Lanfear

Community and purpose are the drivers for everything I do as an Innovative Business Development and Advisory thought leader in Work Force and Life Science. My affiliations working with the Jalen Rose Leadership Academy(JRLA), Whitelake Schools and Promise Schools to drive diverse STEM education is the cornerstone of both my WorkForce and Clinical Research Strategy. My passion for the Future of Work is highlighted by my position as Board of Directors and Chair of Fund Development at the Coalition on Temporary Shelter (COTs) cotsdetroit.org, bringing work opportunities in STEM to all persons of greater Detroit. To do this I collaborate across Consumer Health, Healthcare, BioTech, Pharmaceutical, CRO and Medical Device. My Vision for my customers and partners : Yield Speed to Discovery, Development & Market through Best-in-class in Human Capital and Strategic Workforce Solutions for Life Science organizations. Hybridizing spend-visibility, partner coordination and solution architecture with Talent Supply Chain Management methodology into one optimized Workforce Environment for Drug and Device Development. Uniquely, I have driven strategic workforce operations on both the consulting and sponsor sides of this industry. This has put me in the situations to experience the diverse ways companies execute similar processes and gained me the wisdom to implement best practices derived from these. I have designed and implemented the full suite of Workforce programs across the global including RPO, FSP, CRO, MSP and CWO. I've taken my experiences and shared them with industry leaders through my writing and speaking opportunities. I've thrived due to shared development of ideas in this industry. Specialties: Life Science, Workforce Analysis, Talent Acquisition, Procurement, Global Operational, Strategic Business Development, Bio-Pharmaceutical Operations, Clinical Outsourcing and Vendor Management, Talent Supply Chain Management and Project Excellence.

Mark A. Lanfear's Current Company Details
Proclinical Group

Proclinical Group

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Chief Solutions Officer | FSP - Workforce Solution Architect | Global Staffing & Recruitment Leader | Biopharmaceutical R&D SME | Regulatory Affairs Professional | Certified Clinical Research Associate
Detroit, Michigan, United States
Website:
proclinical.com
Employees:
62
Mark A. Lanfear Work Experience Details
  • Proclinical Group
    Proclinical Group
    Detroit, Michigan, United States
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  • Proclinical Group
    Chief Solutions Officer
    Proclinical Group Dec 2021 - Present
    City Of London, London, Gb
    Executive Vice President and Chief Solutions Officer, Global Head of Solution Architecture, Worldwide FSP (Functional Service Provider) Lead. Flex to Serve (F2S). FSO (Full Service Outsourcing0. Advisory and Consulting. Strategic Staffing. Client Services.As Global Growth Partners, we provide a unique proposition; delivering on every stage of the life science process to help individuals, teams and whole organizations reach their goals faster. Through our suite of services, we help you to grow so that you can bring about a positive impact on global health. Our approach is one of partnership - forming long-term relationships built on integrity and trust. Collaborative from the get-go, our client services team utilize their expertise and understanding to look deeper at your challenges and create tailored solutions.Our Life Sciences sector experts can help you navigate forward and achieve sustainable success in the new outcomes-driven ecosystem of Business, Medical Research, Health Care and Patient outcomes. Proven Business Development and Workforce Product innovator with a track record of commercial accomplishments, market analysis publications, and disruptive influence driving new ideas and industry discussions. Responsible for helping companies to identify business weaknesses and challenges, determine relevant solutions through product development and alliance partnership.
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  • Coalition On Temporary Shelter (Cots)
    Board Of Directors
    Coalition On Temporary Shelter (Cots) Sep 2014 - 2023
    On any given night, there are more than 14,000 homeless in Detroit; one-third of these are children.​For nearly 35 years, COTS has served the most vul­ner­a­ble in our com­mu­ni­ty.​COTS’ Emer­gen­cy Shel­ter oper­ates at capac­i­ty through­out the year, offer­ing pro­grams and pro­vid­ing ser­vices for more than 900 men, wom­en and chil­dren dai­ly.​COTS is one of the largest providers of hous­ing to home­less fam­i­lies in the City of Detroit — shel­ter­ing more than 100 home­less chil­dren night­ly. COTS pro­vides emer­gen­cy shel­ter for fam­i­lies, sup­port­ive ser­vices, mobil­i­ty coach­ing through our Pass­port to Self-Suf­fi­cien­cy™, child care, long-term hous­ing and safe tran­si­tion­al hous­ing for fam­i­lies.​COTS’ Pass­port to Self-Suf­fi­cien­cy™ assists fam­i­lies in reach­ing their hous­ing, eco­nom­ic, health, edu­ca­tion, and career goals through coach­ing, men­tor­ship, and sup­port as they strive to over­come home­less­ness and break the cycle of pover­ty for the next gen­er­a­tion and beyond.
  • Oxford Global Resources
    Vice President And Global Strategy Head, Life Science Sector
    Oxford Global Resources Oct 2018 - Dec 2021
    Beverly, Massachusetts, Us
    World Wide Head of Strategic Accounts in the Life Science sector. Function Service Provider (FSP) Global Practice Leader. Accountable for operational talent delivery into premier client programs. Clinical Research Advisory Subject Matter Expert (SME) for consulting services. Drug and Device Development KOL. Head of Client Services for Life Science Strategic Partnerships. Workforce Solutions Architect
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  • Kelly Services
    Vice President & Global Practice Lead, Life Science Consulting And Outsourcing
    Kelly Services Sep 2011 - Oct 2018
    Troy, Michigan, Us
    Business Development and Recruitment Leader with proven success selling and delivering Enterprise Solutions through design thinking using Alliance Partnerships, FLEX Staffing, FSP (Functional Service Provider), MSP (Managed Service Provider), RPO (Recruitment Process Outsource), CRO ( Contract Research Organization), BPO (Business Process Optimization), and CWO (Contingent Workforce Outsourcing) solutions; to deliver a single-source, optimize and efficient workforce platform globally. Individual Contributor and 3x President's Club winner driving revenue and building new business models. Responsible for talent delivery into FSP/SOW programs.Proven track record building relationships with executives to sell large scale strategic services. Life Sciences & Healthcare Management Consulting Expert. Documented Thought Leader and Advisory Principal for all aspects of global drug and device development.Innovator of ROW Stratigic Partenrship and Alliance Governance.Leader of cross functional teams in R&D, Human Capital Management, and Procurement though Work Force Solution Architecture for Fortune 1000 Clients within the Healthcare Value, Medical Device, Biopharmaceuticals.Management Consulting for Business Units and Divisions in US and EMEAOversee Execution of solutions using Workforce Planning & Analysis combined with Talent Supply Chain Management methodology blending Research & Development and Life Science with Workforce solutions.
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  • Advanced Clinical
    Vice President Clinical Operations
    Advanced Clinical Aug 2010 - Sep 2011
    Deerfield, Illinois, Us
    Commercial and Client Relationship Leader. Reporting to the CEO, devlivering Strategy & Leadership leading to outsized profitable growth. Innovative Go-to-Market and Product Develoment Strategy, Sales and Marketing Effectiveness, and Pricing & Promotional Effectiveness. Developed consulting and advisory offerings. Individual contributor leading, prospecting and delivering business development oportunities for all solutions. Global cross-functional teams in sales and operations to deliver high quality engagements within timeline and budget. Advisory and Thought leader analysiing and creating business and industry trends eccential to the fortune 500 client's business. Cost Transformation – Share intilecutal capital to driving business diagnostic ans organizational effectiveness.– Structure & Organizational Design, Process Optimization, Performance and Program Management Clinical Operations and Development. Expert and thought leeader on Human Capital Management, Clinical Research Organisation Sloutions, Strategic Sourcing, and Supply Chain Design and Management.-Responsible for P&L, Investment, budgeting and and allocation leading quickly reaching internal and external business opperation goal-Accountable for Clinical Research Operartions and uccessful prgram execution globally for our customers and partners.-Advised product develoment and marketing across our business units-Supported FDA and MOH approvals for our partners and programs through advisory and subject matter expertise-Advanced scientific and operational skill/knowledge through professional organizations and conference participation
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  • Kforce Global Solutions, Inc.
    Vice President, Head Of Strategic Accounts And Fsp
    Kforce Global Solutions, Inc. Aug 2008 - Aug 2010
    Tampa, Florida, Us
    Commercial and Client Relationship Leader over FSP and Strategic Accounts. Accountable for Talent Acquisition, Operational Execution and Revenue Growth. Directed the AMER, EMEA, and APAC Strategic Alliance Workforce Solutions and Operations between Kforce Inc and its Pharmaceutical partners. Reporting to the President of Kforce Clinical Research, Lead and inspire a team of 5 Directors of Business Development and 6 VP of Clinical Operations. Accountable for 250 million dollar P&L and delivering outsized growth as compared to the market place. Provided leadership to recruitment teams, strategic oversight and guidance of the clinical operations organization to meet quality, timeline, resourcing and budgetary goals Lead the scientific and clinical activities, including grants, publications, evidence, relationships with medical stakeholders, Advisory Boards, clinical education, and overall medical strategy. This team was uniquely positioned to deliver highly credible, scientific advisory and information to internal and external stakeholders.
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  • Hoffmann-La Roche
    Director Clinical Development
    Hoffmann-La Roche Feb 2005 - Aug 2008
    Switzerland 🇨🇭 , Ch
    Clinical Operations over Study Management and Monitoring. Responsible for program budget and reaching operations milestones. Established and approved scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Responsible for directing human clinical trials, phases I-IV for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinated and developed reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion. Responsible for the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements. Develops and implements clinical program strategy and directs those systems and programs in order to meet Company goals and objectives. Lead and managed staff, responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews, participated in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Directed the design of pivotal clinical studies for product and registration. Identifies and develops collaborations with external investigators and opinion leaders. Responsible for working closely with and managing groups such as, Clinical Research, Data Management ,Regulatory Affairs, Clinical Operations, Marketing and Business Development. Acts as a clinical opinion leader working with physicians at a peer level. Works closely with Data Management and Biostatics to provide clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products. Vendor Management and act as consultant/liaison with other corporations when working under licensing agreements. Recruit clinical investigators and negotiates study design and costs.
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  • Kv Pharmaceutical
    Director Clinical Development
    Kv Pharmaceutical May 2003 - Mar 2005
    Chesterfield, Mo, Us
    -Gained FDA approval for products.-Contributed to IND and NDA submissions-Executed Early Phase and Pivotal Clinical Trials GlobalPushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery. Pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. Oversaw, lead and managed cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors and consultants) to conduct trials on time, on budget, in compliance and of highest quality. Directed Clinical Project Management and Clinical Study Monitoring. Responsible and accountable for the outcomes of programs. Lead the coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).Planned and managed Investigator meetings, advisory boards and other scientific committees, as required by the protocol (e.g. independent reviews, DSMBs etc.).Provide business and clinical input to help evaluate and priorities new product development opportunities, both internal and external. Provide business input to preclinical research teams to support optimal development of potential new products. Developed and managed a network of external experts relevant to the company's development programs and seek out competitor intelligence.Qualify, manage and maintain relations with all external vendors, including CROs, clinical trial sites, Principal Investigators and patient recruitment programs, delivering to target.
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  • Pfizer
    Senior Manager Clinical Operations
    Pfizer Sep 2000 - May 2003
    New York, New York, Us
    Innovative, risk manager, with the ability to interpret the overall division’s strategy to establish business priorities that support and achieve the set long term direction and strategy.-Directed and executed global Phase II, III, IIIB, and IV Clinical Trials.-Achieved NDA Approval on 2 metabolic Disease products-Lead a multidiscipline team of Clinical Operations, Data Management, Statistics, Medical, and ProgramingAccountable for the day-to-day oversight of all clinical, scientific, technical and operational aspects of the clinical trials. Including feasibility, study placement and scheduling, volunteer and patient recruiting, project management, clinical operations staffing and resource management, quality activities and data management.Participates in strategic planning with Pfizer global leadership, lead strategic planning for the clinical research teams within my group and levering technical/functional expertise internally and externally. Oversaw project management function ensuring cross functional project leadership for Pfizer study teams regarding input into protocol development; study feasibility and execution; study delivery according to agreed quality, timeline and cost parameters; study data integrity and data quality, and; study compliance with GCP, relevant SOPs and local regulatory requirements. Oversaw the recruitment function including volunteer and patient recruitment deliverables (eg, activities related to volunteer database management, preselection of suitable study candidates and overall interaction with clinical trial volunteers); development and management of volunteer recruitment capabilities to conduct a broad range of exploratory development studies; long term recruitment planning (eg, anticipation and preparation for all exploratory and full development studies conducted); and; building/ enhancing capabilities in recruitment and volunteer outreach (eg, social media and identifying and leveraging new channels for advertisement
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  • Abbott
    Clinical Project Manager
    Abbott Jul 1998 - Sep 2000
    Abbott Park, Illinois, Us
    Designs; implements; and monitors clinical studies of new and modified products. Ensures that the clinical studies are designed to validate the products’ intended use and meet regulatory requirements. Ensures clinical studies are conducted in compliance with Good Clinical Practice (GCP). Prepares clinical data reviews and participates in the preparation of regulatory submissions. Manages large projects; more complex projects; and/or several smaller related projects.-Supervise clinical research associates (CRA) and other employees in the completion of tasks and projects; train and mentor new employees; and serve as a resource for newly hired CRAs.-Prepare and/or approve design validation plans; clinical protocols; clinical brochures; case report forms; sample consent forms; statistical plans; and other required documents for clinical studies.-Identify and qualify clinical investigators and clinical sites; proposes and negotiates budgets for clinical studies; initiates and track payments to sites and manage expenses within study budget.-Manage or coordinate all aspects of the clinical monitoring process in compliance with GCP guidelines and regulations including review of all required essential documents necessary for study initiation and ensure audit ready study files throughout the duration of the study.-Conduct site visits to provide training for investigator and staff; determine protocol and regulatory compliance and prepare required documentation ensuring data reported is accurate; complete and verifiable.-Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates. Early identification of unsatisfactory results; operations; or specific problems allows immediate action to be taken by appropriate groups. Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project. Accountable for project scope and scheduled completion date.
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  • Lilly Venture (I3 Statprobe)
    Manager, Clinical Operations
    Lilly Venture (I3 Statprobe) Jun 1996 - Jul 1998
    Gb
    Responsible for strategic oversight and leadership direction within the Clinical Operations function and team.Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates. Early identification of unsatisfactory results; operations; or specific problems allows immediate action to be taken by appropriate groups. Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project. Accountable for project scope and scheduled completion date. Works under general management direction. Participates in professional activities in the US and/or Internationally. Responsible for mentoring direct reports and their career development.
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Mark A. Lanfear Skills

Cro Clinical Trials Pharmaceutical Industry Strategy Leadership Management Clinical Development Talent Management Outsourcing Lifesciences Talent Acquisition Business Development Clinical Research Life Sciences Ctms Cro Management Program Management Recruiting Business Process Improvement Life Science Industry Project Management Consulting Biotechnology Vendor Management Oncology Good Clinical Practice Medical Devices U.s. Food And Drug Administration Regulatory Affairs Msp Cross Functional Team Leadership Drug Development Pharmaceutics Customer Relationship Management Customer Experience Account Management Healthcare Consulting Strategic Consulting Consultative Selling Drug Discovery Product Launch Competitive Analysis Marketing Business Intelligence Data Analysis Commercialization Public Speaking Customer Service Team Building Negotiation Clinical Operations Supply Chain Consulting Strategic Business Strategic Planning

Mark A. Lanfear Education Details

  • University Of Michigan
    University Of Michigan
    Physical Therapy

Frequently Asked Questions about Mark A. Lanfear

What company does Mark A. Lanfear work for?

Mark A. Lanfear works for Proclinical Group

What is Mark A. Lanfear's role at the current company?

Mark A. Lanfear's current role is Chief Solutions Officer | FSP - Workforce Solution Architect | Global Staffing & Recruitment Leader | Biopharmaceutical R&D SME | Regulatory Affairs Professional | Certified Clinical Research Associate.

What is Mark A. Lanfear's email address?

Mark A. Lanfear's email address is ma****@****bal.net

What is Mark A. Lanfear's direct phone number?

Mark A. Lanfear's direct phone number is +184726*****

What schools did Mark A. Lanfear attend?

Mark A. Lanfear attended University Of Michigan.

What skills is Mark A. Lanfear known for?

Mark A. Lanfear has skills like Cro, Clinical Trials, Pharmaceutical Industry, Strategy, Leadership, Management, Clinical Development, Talent Management, Outsourcing, Lifesciences, Talent Acquisition, Business Development.

Who are Mark A. Lanfear's colleagues?

Mark A. Lanfear's colleagues are Anna Klemencic, 平林唯, Brigitte Walter, Jana Van Zyl, Jessica Gibson, Star Jones, Dante Powell.

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