Robert Exner Email & Phone Number

Westport, Ct, Us

Our Mission is to help clients in the Biotechnology Sector develop operationally excellent and scalable Clinical Operations solutions for their Clinical Research and Development programs. Our focus is to accelerate our clients' timeline to bringithier products to market.

New York, New York, Us

Engaged to integrate the vendors and vendor contracts of an acquired company in to Pfizer systems and processes and to manage the outsourcing process of clinical, early phase, and biosimilar studies. As an Outsourcing Lead, I am directly responsible for preparation of requests for proposal, contract development, contract negotiation, contract execution, amendments and change orders, of all categories of Pfizer agreements and for minimizing business risk and maximizing research dollars of each contract.

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Managed and provided strategic leadership to the company’s Contract Management, Clinical Outsourcing, Study Startup, Clinical Budgeting, and Clinical Trial Liability Insurance Functions. Responsible for growth and development of 15 employees across the six functions. Set quality standards, oversight plans and provided oversight of Contract Research Organization (CRO) performance as member of the company’s CRO Oversight Steering Committee. Won Presidents Award for successfully integrating two acquired companies and their studies into Forest's processes and procedures.

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Reduced Clinical Trial Liability Insurance costs by 50% by creating a strategic function to procure policies and by streamlining the procurement process. Created, staffed, and led a Clinical R&D Budgeting Group, which increased budget forecast accuracy by 10%.

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Reduced R&D costs by $2.25M annually through the implementation of targeted cost benchmarking and controls. Partnered with Human Resources and Strategic Sourcing to establish preferred staffing agencies for the company.

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Drove expansion of the Contract Management and Outsourcing Functions to support Drug Discovery, Toxicology, Early Phase Development, and Investigator Initiated Research.

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Recruited to start a new clinical Contract Management and Outsourcing Department to streamline operational efficiency and maximize productivity of Phase II-IIIb Cliical Trials. Accountable for all startup activities, including talent acquisition and developing core operational strategies, processes and procedures.

Lawrence Township, Nj, Us

Facilitated creation of unified global CRO outsourcing strategy, best practices, and related training program for suppliers and employees. Won the President’s Award for contributions. Excelled in team leadership, financial control, performance measurement and effective operational streamlining.

End to end Clinical Trial Management of non-small lung cancer clinical trials, including protocol and Case Report Form design, planning investigator meetings, site selection, contract negotiations, study startup, clinical supply management, interim monitoring, Serious Adverse Event reconciliations, and study closeout.

End to end Clinical Trial Management of Pediatric Acute Lymphoblastic Leukemia clinical trials, including protocol and Case Report Form design, planning investigator meetings, site selection, contract negotiations, study startup, clinical supply management, interim monitoring, Serious Adverse Event reconciliations, and study closeout.

Performed interim monitoring and site management of ten sites across of six sponsored clinical HIV studies.

Coordinated the scheduling of two scientists performing experiments across a wide variety of invivo experimental studies. Took a lead role in development and execution of relevant in vivo models critical to the evaluation of compound activity. Provided review and input on new therapeutic opportunities, competitive intelligence and participated in collaborations with partners regarding disease area activities.

Master Of Business Administration (Mba), Strategic Leadership

Bachelor Of Arts (Ba), Biology And English