GPD VP - Part time

The Rare Disease Therapeutic Area Vice President 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 positionThe 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 issuesInvestigational product class issuesProtocol and indication considerations, including safetyTeam education on indicationInteractions with client physicians and/or client TA Head or CMO 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 CMOs, TA Heads and senior medical directors of companies whose product portfolio contains investigational products of business interest to PPDStrategic alliance development & supportClient governance or advisory boardsPPD® Consulting practiceThrough 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 Rare Disease strategy team, 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 investigational 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

The Rare Disease Therapeutic Area Vice President 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 positionThe 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 issuesInvestigational product class issuesProtocol and indication considerations, including safetyTeam education on indicationInteractions with client physicians and/or client TA Head or CMO 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 CMOs, TA Heads and senior medical directors of companies whose product portfolio contains investigational products of business interest to PPDStrategic alliance development & supportClient governance or advisory boardsPPD® Consulting practiceThrough 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 Rare Disease strategy team, 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 investigational 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

Job Qualification:MD or equivalent required;Minimum of 10 years of post-education experience in clinical and/or research settingMinimum of 5 years of global HemOnc development experience (Gene Therapy exp preferred) and 3 years in a leadership role in the pharmaceutical, biotech or CRO IndustryExcellent verbal and written communication skills

Job Qualification:MD or equivalent required;Minimum of 10 years of post-education experience in clinical and/or research settingMinimum of 5 years of global HemOnc development experience (Gene Therapy exp preferred) and 3 years in a leadership role in the pharmaceutical, biotech or CRO IndustryExcellent verbal and written communication skills