Exec Med Dir/VP Global Prod Development

This is a leadership role that requires proven abilities to drive both strategic innovation and measurable business outcomes. The incumbent’s track record of therapeutic expertise will be extensive and ensure recognition of the incumbent as a peer of their Pharmaceutical Industry equivalents. This position will play a key part in the future business success of PPD as it seeks to continue its track record of successful growth and expand its Industry leading position.

The role comprises four major functions:First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs) including:Development strategy and regulatory issuesDrug class issuesProtocol and indication considerations, including safetyTeam education on indicationInteractions with client physicians and/or client TA Head prior to or during the bid defenseIdentifying opportunities for PPD® consultingSecondly, the incumbent is responsible for supporting outstanding input into other areas of PPD’s business activity including:Pro-active client engagement: peer-to-peer interaction with TA Heads and senior medical directors of companies whose product portfolio contains drugs of business interest to PPDStrategic alliance development & supportClient governance or advisory boardsPPD® Consulting practice. Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans, and top level design of clinical trial protocols that are required in the planThirdly, the incumbent will provide a supporting role in PPD’s Therapeutic Area Strategic Team (TAST), a cross functional team charged with championing PPD’s business development by creating focused solutions for client companies. Examples of activities related to the development of these integrated business offerings to client companies include:Identifying strategic client opportunitiesClient pipeline analysisIdentifying drug product opportunitiesPartner with business development to implement specific strategies to grow therapeutic area book of businessEvaluating and integrating PPD’s service offerings, such asPhase 1 first in human testing capabilitiesClinical trial operations expertiseRegulatory intelligence expertiseLaboratory capabilities (including biomarkers)Imaging capabilitiesPost-approval studies and outcomes expertiseSpecial services – i.e. DSMB management, ARO partnershipFourthly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal PPD teams including:Indication-specific training for clinical teamsGuidance during clinical trial executionClinical data review and evaluationInvestigator brochure, clinical study report, NDA/MAA documents, and regulatory briefing documents review and editingContribute to design and reporting of feasibility studiesLiaise with investigators and KOLsMentor and supervise TA clinical scientists

This is a leadership role that requires proven abilities to drive both strategic innovation and measurable business outcomes. The incumbent’s track record of therapeutic expertise will be extensive and ensure recognition of the incumbent as a peer of their Pharmaceutical Industry equivalents. This position will play a key part in the future business success of PPD as it seeks to continue its track record of successful growth and expand its Industry leading position.

The role comprises four major functions:First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs) including:Development strategy and regulatory issuesDrug class issuesProtocol and indication considerations, including safetyTeam education on indicationInteractions with client physicians and/or client TA Head prior to or during the bid defenseIdentifying opportunities for PPD® consultingSecondly, the incumbent is responsible for supporting outstanding input into other areas of PPD’s business activity including:Pro-active client engagement: peer-to-peer interaction with TA Heads and senior medical directors of companies whose product portfolio contains drugs of business interest to PPDStrategic alliance development & supportClient governance or advisory boardsPPD® Consulting practice. Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans, and top level design of clinical trial protocols that are required in the planThirdly, the incumbent will provide a supporting role in PPD’s Therapeutic Area Strategic Team (TAST), a cross functional team charged with championing PPD’s business development by creating focused solutions for client companies. Examples of activities related to the development of these integrated business offerings to client companies include:Identifying strategic client opportunitiesClient pipeline analysisIdentifying drug product opportunitiesPartner with business development to implement specific strategies to grow therapeutic area book of businessEvaluating and integrating PPD’s service offerings, such asPhase 1 first in human testing capabilitiesClinical trial operations expertiseRegulatory intelligence expertiseLaboratory capabilities (including biomarkers)Imaging capabilitiesPost-approval studies and outcomes expertiseSpecial services – i.e. DSMB management, ARO partnershipFourthly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal PPD teams including:Indication-specific training for clinical teamsGuidance during clinical trial executionClinical data review and evaluationInvestigator brochure, clinical study report, NDA/MAA documents, and regulatory briefing documents review and editingContribute to design and reporting of feasibility studiesLiaise with investigators and KOLsMentor and supervise TA clinical scientists

Education and Experience Required:MD or equivalent requiredMinimum of 10 years of post-education experience in clinical and/or research settingMinimum of 5 years of global drug development experience and 3 years in a leadership role in the pharmaceutical or CRO IndustryExcellent verbal and written communication skills Education and Experience Required:MD or equivalent requiredMinimum of 10 years of post-education experience in clinical and/or research settingMinimum of 5 years of global drug development experience and 3 years in a leadership role in the pharmaceutical or CRO IndustryExcellent verbal and written communication skills