We have a vacancy for Exec Med Director - Global Product Development - Nephrology. The GPD leadership role 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: 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 Therapy Area leaders prior to or during bid defensesIdentifying business opportunities for PPDResponsible for supporting outstanding input into other areas of PPD's business activity including:Pro-active client engagement: peer-to-peer interaction with TA leaders and senior medical directors of companies whose product portfolio contains drugs of business interest to PPDStrategic alliance development & supportClient governance or advisory boardsThrough 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 plan.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 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 as Phase 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 partnershipResponsible 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 clinical scientistsKnowledge, Skills, and Abilities: Thorough understanding of overall biologic/pharmaceutical product development process, from pre-clinical through post-marketing, including all stages of development and all functional rolesTherapeutic and indication-specific development expertise across one or more therapeutic areas and one or more drug classes, including deep knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscapeThorough understanding of core cross-functional concepts (e.g., preclinical, translational medicine, CMC) and major program requirements at different development stagesDeep knowledge of important regulatory considerations and experience with FDA, EMA and other national regulatory authoritiesExperience as a medical strategy leader on one or more asset development teamsExperience with KOL and investigator interactionsStrong decision-making and analytical skillsExcellent communication and influencing skillsExcellent organizational skills and detail-orientated leadership approachFlexibility to travel domestically and internationallyAbility to work independently on multiple tasks in a fast-paced environmentEducation and Experience: MD or equivalent with experience implementing therapeutic programsNephrology experience requiredDirect experience with the creation and implementation of full asset development including pre-clinical, clinical, regulatory, CMC and (if applicable) biomarker strategy developmentOur Mission is to enable our customers to make the world healthier, cleaner and safer.
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