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;

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.
• 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).

• 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.
• 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

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.
• 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)

Doctor Of Law - Jd

Mba, Finance, General

Phd, Pharmacology

Bs, Neuroscience