Global Clinical Trial Project Manager

JEFFREY BURGESS

***** ******** **., ******, ** **074 (C) 317-***-**** ********@***.***

professional summary

Seasoned Clinical Trial Project Manager with more than 22 years of experience planning, developing and implementing ~25 clinical trials ranging from phase 1, exploratory to phase 3, global pivotal trials. Focus has been CRO-managed trials over the past 10 years; currently starting up a global phase 3 that is managed in-house.

Leadership: Leading cross-functional global teams, budget development & management of multi-million dollar budgets (typical phase 3 of ~ $60M). Skilled at budget forecasting, risk assessment/mitigation and problem solving.

skills

•Clinical trial leadership experience includes protocol writing, exploratory to late-phase clinical trial development, cross-functional management. Expertise in clinical trial budget development, forecasting & control. Timeline development and risk assessment, vendor management, global trial planning & implementation, clinical trial reporting & close-out, FDA submissions, inspection readiness and support of an on-site, sponsor FDA inspection.

• Strong knowledge of regulations, guidelines & GCPs for conducting global clinical trials.

• Sponsor and CRO clinical research project management, building high-performing teams, relationship management, vendor bid assessment, change control, negotiation

• Process improvement, trial management tool development, coaching

Knowledge of therapeutic areas: Autoimmune (psoriasis, psoriatic arthritis, spondyloarthropathies, atopic dermatitis), Neuroscience (Neurodegenerative, Mood & Sleep Disorders; migraine & pain)

• Microsoft Office suite (especially Excel & Project), Outlook

work history

Eli Lilly & Company, Pharmaceutical Indianapolis, IN Jun 1991 – Current

Global Clinical Trial Project Manager (Feb 2011 – current)

Manages multiple clinical trials in the autoimmune portfolio.

Expert at coordinating all trial development & execution activities via cross-functional teams and vendors according to the contract and scope of work.

Proven accountability in support of an NDA global submission, follow-up safety submission and on-site FDA inspection (lead CTPM for OSI/BIMO, Financial Disclosure data completeness, accuracy and reporting)

Proven project leadership in managing cross-functional teams with delivery of right to operate documents (e.g. IB and annual reports) and notable patient narratives for NDA ahead of deadline.

Manages expanded access trial for Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated Temperature (CANDLE) Syndrome, CANDLE-like syndrome, SAVI and AGS.

Associate Consultant Clinical Trial Manager (Aug 2005 – Jan 2011)

Managed multiple clinical trials in the neuroscience portfolio: sleep disorders.

Lead cross-functional study teams in the development and execution of the trials. Accountable to deliver trials with quality, on time, and within scope and budget

Aggressively recruited by COO to the transition to phase 3 team. Partnered with CRO in the planning, design & sourcing strategy for the phase 3 program

Managed and executed a complex exploratory phase 2 sleep disorders study that involved polysomnography & e-data capture. Lead the CRO RFI-Bid selection process, contracts and procurement process

Sr. Portfolio Clinical Development Associate (Apr 2004 – Jul 2005)

Managed multiple clinical trials in the neuroscience portfolio: sleep disorders.

Lead cross-functional study teams in the development and execution of the trials.

Sr. Clinical Development Associate (Apr 2001 – Mar 2004)

Managed multiple clinical trials in the neuroscience portfolio: migraine & pain

Lead cross-functional study teams in the development and execution of US-only clinical trials.

Part of a small team that designed, developed and executed trials under an novel, exploratory development set of SOPs.

Oversaw the activities of the small group of CRA who monitored the trial.

Clinical Development Associate (Jan 2000 – Mar 2001)

Managed multiple clinical trials in the neurodegenerative disorders portfolio: ALS

Lead cross-functional study teams in the development and execution of US-only clinical trials.

Clinical Research Associate (Jul 1996 – Dec 1999)

Managed clinical trial activities for Phase II in Neuroscience (anxiety, depression), erectile dysfunction.

Performed site evaluations, initiations, data cleaning/query review, closeouts and the writing of patient narratives for clinical study reports.

Associate Pharmaceutical Project Manager (Jul 1994 – Jul 1996)

Co-lead cross-functional teams with lead manager with the planning and development of new drug candidates (neuroscience, depression and urinary incontinence)

Virologist (Jun 1991 – Jun 1994)

Hepatitis B research. Optimized and ran bioassay lab operation to rapidly screen bioavailability of HIV protease inhibitor candidate molecules.

Pandex Corporation, Biotechnology Mundelein, IL Aug 1988 – May 1991

Virologist

Created cell lines expressing viral antigens and scaled production for this biotech’s magnetic bead-based, automated immunoassay technology

education

University of Illinois at Champaign-Urbana Champaign, IL

Bachelors of Science: Biochemistry & Microbiology

accomplishments

As Lilly clinical project manager, built and managed a team that was awarded with the Quintiles-Customer Joint Operations Committee Excellence in Partnership Award.

As Lead Sponsor Clinical Trial Project Manager, supported the successful, on-site FDA inspection: neither significant findings nor requested interviews during the one-week inspection.

Recipient of stock grant awards for excellent performance.

Recognized across the clinical development organization as a budget subject matter expert.

certifications

Certified Project Manager (completed week-long Certified Project Manager Boot Camp)

references

Provided upon request

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