Richard Gill, President

Who I am:

Analytical, energetic and innovative pharmaceutical industry professional with 25 years operational and compliance experience.
Highly successful corporate team player.
Process-oriented, with exceptional logical, problem solving and organizational skills.
Direct, clear communicator with ability to communicate at all levels of an organization.

Expertise:

Instituting compliance programs that meet regulatory and legal requirements, including procedural frameworks, risk-based auditing and employee training programs.
Leading cross-functional groups to establish efficient, high-quality and compliant working practices.

International Pharmaceutical Development Experience

RCG Consulting, Inc.

President 2007 -

Established a consulting business offering compliance and operational support to biopharmaceutical and device companies.

Successfully supported 17 pharmaceutical companies in preparing for FDA and EMA sponsor-monitor inspections.
Inspection readiness for $20B healthcare company in advance of triggered regulatory inspection.
Advice on management of late-phase clinical studies and role of MSLs for a leading oncology company.
Development of pharmacovigilance processes for 3 global organizations.
Reengineered QA function for an 80% down-sized biopharmaceutical company.
Reorganized global quality function to provide QA operation, auditing and validation groups supporting GXP activities.
Procedural framework for one of the top 6 global Pharmaceutical companies.
Process mapping of Development operations for $250M oncology company.

Chiron Corporation, Emeryville, CA

Vice President, Compliance and Process Improvement 2005 - 2006

Reported to the SVP, Global Regulatory Affairs, Pharmacovigilance & Compliance with dotted line report to President, BioPharmaceuticals.

Established commercial compliance function meeting PhRMA and OIG Guideline requirements.
As Corporate Compliance Officer for BioPharmaceuticals, developed key corporate policies and practices.
Led cross-functional team to develop and implement global Development work practices.
Implemented business continuity plans for Development organization.

Elan Pharmaceuticals, San Diego, CA 2002 – 2005

Vice President & Global Head, Quality & Process

Reported to the EVP, Antegren Business as a member of the Tysabri® launch team. Involved in key strategic decisions regarding sales, marketing, medical support, distribution and pricing of this blockbuster. Ensured key processes would support commercialization of Tysabri® in two indications:

Designed and built-out customer support services, including product website.
Established data feeds to provide management reporting metrics.
Implemented global pharmacovigilance process.

Vice President, Global Regulatory Compliance

Reported to the President, Research & Development and responsible for driving initiatives to optimize the output of Elan’s Global Development function.

Implemented a global GCP-QA Group with audit, SOP and document management, training and IT validation functions to support clinical studies of development (Antegren, Prialt, Alzheimer’s program) and marketed (Zonegran, Myobloc) products.
Led cross-functional teams to develop global clinical operational structure.
Created and led Strategic Outsourcing function and, through new preferred provider relationships, reduced outsourcing spend >$7M during the period 2003-5.

Quintiles Transnational Corp., Durham, NC 1999 – 2002

Head, Global Quality Management Group

Reported to the CEO, Clinical Development Services with dotted line report to SVP, Corporate Compliance. Established and led this group, focusing on initiatives that reduced corporate risk.

Analyzed competitive intelligence and customer feedback to identify and remediate areas of business vulnerability.
Managed and re-engineered centralized subject enrollment, randomization and drug management services (IVR Services).
Led global Part 11 compliance program.

Acting General Manager, Quintiles Laboratories

Reported to the Global COO of this $100M global analytical laboratory headquartered in Atlanta. Working with Outside Counsel, led and managed six functional areas (350 people) and re-engineered business process to optimize operational efficiency, ensure data integrity and meet regulatory and contractual obligations.

Campbell Charles Associates Limited, East Horsley, Surrey, UK

Founder / Managing Director 1988 – 1999

Campbell Charles Associates was a boutique provider of pharmaceutical development resource to international drug companies. Responsible for founding this company and management of clinical research, business development and medical advisory personnel.

Provided clinical trial services to clients including: Bayer (metrifonate, oxymoxyfloxaccin), Glaxo (ondansetron), Kabi Pharmacia (terodiline), Medeva (tetanus/diphtheria and flu vaccines), Rhone Poulenc (zimovane, perchlorperazine), Sanofi Winthrop (ciprofibrate, verapamil), Solvay-Duphar (fluvoxamine) and Zyma (OTC cold medications).
Expanded corporate experience to encompass 18 therapeutic areas, including cardiovascular, CNS, endocrinology, neurology, urology and virology/immunology.

May & Baker Pharmaceuticals Limited, Dagenham, Essex, UK

Senior Clinical Research Associate 1986 – 1988

Reported to the UK Medical Director. Jointly responsible for the planning, initiation, monitoring and reporting of Phase 1-3 studies within the CNS Area. Products included chlorpromazine (Largactil), perchlorperazine (Stemetil and Stemetil Eff), pipothiazine (Piportil), suriclone and zopiclone (launched as Zimovane).

Summary of Education, Qualifications and Interests

Six Sigma Black Belt                                       2001
PhD in Experimental Surgery (University of London)                   1983
BSc (First Class Honours) in Biochemistry/Physiology (University of London)       1978