Doug Lytle, Phd, Mba, Jd Email & Phone Number

Bethlehem, Pa, Us

Durham, North Carolina, Us

NOT a new position - I am continuing my role and responsibilities which started at Covance, Labcorp Drug Development and now Fortrea. Fortrea is a carve out of Covance/Labcorp CRO services that are focused on executing Phase 1-4 clinical trials with excellence.

Burlington, North Carolina, Us

• Advised on strategies for 100+ FIH Phase 1 and clinical pharmacology studies; • Trained and consulted on Diversity Action Plans for clinical studies; • Reviewed and revised clinical pharmacology protocol designs and timelines;• Developed and reviewed documents for IND, IB, protocols, and other regulatory submissions;• Collaborated with nonclinical teams to transition from IND-enabling to Phase I studies;• Worked on studies using small molecules, proteins, and large molecules in all therapeutic areas;• Mentored and educated teams within the Clinical Pharmacology business development group;• Conducted legal review of FAR clauses and government requirements for SAM registration;• Implemented financial forecasting to track sales and revenue goals;

Research Triangle Park, Nc, Us

I serve as a leader for the Clinical Assessment Technologies (CAT) department supervising a team of 16 project management and clinical team members. CAT provides specialized compliance of clinical trial sites to increase the reliability of efficacy assessments. I was brought on to: 1) streamline/upgrade all aspects of our processes, 2) implement technologies to improve operations, and 3) facilitate business development.Key achievements include:• Developed and deployed innovative patient eligibility review process, going beyond traditional in/exclusion criteria* Produced ten (10) detailed and refined process maps for all departmental services* Updated all (3) departmental SOPs and Working Instructions (4) with updated process maps* Accountable and responsible for development of study-specific plans and timelines* Ensured departmental compliance, never received internal or external CAPA; resolved previous CAPAs and audit findings* Developed and deployed company-wide, SharePoint-based RAID log (Risk, Actions, Issues and Decisions)* Established four (4) key and ten (10) ancillary departmental KPIs; managed all within acceptable/green levels* Deployed external vendor solution to capture TMF-quality surveys at sites * Spoke/presented at four (4) international conferences and five (5) IMs as subject matter expert* Hired six (6) new team members in roles ranging from Project Associate to Director level* Integrated EDC solutions to automate and streamline processes saving >60 hours weekly * Developed data visualizations/dashboards of key efficacy and safety assessments, including specific views that streamlined a patient-specific clinical review process* Transitioned three strategic clients from very dissatisfied to satisfied/happy; maintained every client with satisfied to very satisfied dispositions* Completed comprehensive competitive landscape of all rater reliability competitors; developed strategy to increase competitive position in the industry

Consult with clinical study teams and Sr Leadership positions within the pharmaceutical industry to deploy the best services and technologies that optimize site start up, patient recruitment/engagement, and overall clinical trial management. • Worked directly with 15 clinical teams post award to implement specific areas improvements in clinical studies• Consulted with ~80 project teams across 35+ pharma companies to address specific issues with clinical studies• Responsible to develop and deploy innovative site startup and global patient engagement solutions• Developed specific expertise as a site compliance (GCP, SAE, etc.) and CNS Rater Reliability Specialist• Significant focus on making oncology studies more efficient during startup and enrollment periods• Helped develop and designing a comprehensive site startup service able to get academic sites IP ready in 2 months• Collaborated with groups in Medical Affairs, Clinical Operations, Project Management and Clinical Development• Deployed global post-marketing study with branding and brand awareness to facilitate marketing and development• Increased site compliance and patient compliance using tools and clinical trial technologies at sites and with patients• Implemented technologies and services to make Investigator Meetings more efficient and effective• Worked closely with local and central institutional review boards (IRB) to expedite and facilitate ethical review of protocols, informed consents (ICF) and protocol amendments

Zug, Ch

A Senior Leadership role in a Clinical Research Organization (CRO) serving the pharmaceutical industry within the clinical development function. I delivered proposals, budgets and strategies, focusing on medical and technical challenges of protocols across Central/Eastern Europe and the US. • Consulted on proposals, documentation and strategies, focusing on medical and technical aspects of protocols• Served as a medical leader at bid defense meetings and in proposal development process• Provided strategic insight into key aspects and protocol specific challenges of clinical development • Concentrated in oncology (three pancreatic protocols, bladder and AML, CLL, others)

Slough, Berkshire Sl1 4Aa, Gb

• Brought in long term, global clinical research partnerships with budget values over $100 million in 2008-2009• Developed new top-five pharma account which became one of top three clients in 2006, 2007 and 2008• Strategic lead for Vaccine and Biological sales initiatives; developed oncology and traditional vaccine clients• Managed and mentored new and junior team members – documented and delivered training in GCP and SOPs• Lead various key partnerships strategies, negotiations, and strategic plans to gain new customers

Dublin, Ie

• Immediate impact by winning over $4 million of work across two clients within first two months of start• Recovered relationships with two key customers after poor project management and communication issues• Worked with groups in Medical Affairs, Clinical Operations, Project Management and Clinical Development

Us

Started in finance department, then moved to general clinical management and then managed change order development and negotiation for entire company.• Head of Change Order Development and negotiated $10 million of budgets in 2001 and 2002• Clinical operations management remits assigning and accounting for CRA responsibilities• Lead company-wide monthly clinical budgets, operations and project management meetings • Forecasted budgets and revenues and identified variances from project and departmental budgets• Managed staff of 5+ people in two separate roles (accounting, finance and operations)• First trained on GCP, Safety Reporting, SOPs and compliance in clinical research and project management

Doctor Of Law - Jd

Mba, Finance, General

Phd, Pharmacology

Bs, Neuroscience