OverviewSRG are working with a global pharmaceutical company seeking a Clinical Development Director to join their team.Job Title: Clinical Development Director – ImmunologyContract Type: 18 monthsLocation: Hybrid or RemoteJob purposeThe Clinical Development Director (CDD) is a clinical/scientific expert responsible for leading and supporting clinical development deliverables within a global clinical program or trial. This role operates under the leadership of the Global Program Clinical Head (GPCH).Key ResponsibilitiesSupports and if assigned leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review and program specific standards, clinical components of regulatory documents/registration dossiers, and publicationsProvides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentationsLeads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)Oversees/conducts ongoing clinical and scientific review of clinical trial data with medical monitor, Clinical Scientific Expert(s) with appropriate oversight from Medical Lead. Works in close collaboration with the data management and statistics teams to ensure proper data quality and analysis of clinical trial resultsInspection Readiness and interaction with QA - risk assessments, audit preparation, mock interviews, storyboard and presentation prep; Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and contentMay be the Program Manager of other associates (e.g., CSE)Provides support to Sr CDMD and/or GPCH in monitoring and safety data and signals the molecule for the assigned section of the clinical trial, may be a member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., PSURs, DSURs, and other safety related documents) in collaboration with the medical monitor, CDMD and Patient SafetyAs a clinical development expert, may support the GPCH or CDH in interactions with external stakeholders (regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boardsMay work with Biomedical Research/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with other medical mattersEnsures career development of Program reports and other clinical colleagues through active participation in performance management and talent planning processes. Provides on-boarding, training, & mentoring supportContributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific trainingMay serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)May be assigned to lead clinical trial(s) as Clinical Scientific Lead and provide leadership and guidance for all clinical aspects of a clinical trial in close collaboration with the assigned medical monitor and/or CDMDRequirementsQualified in Immunology or related field. PhD preferredExtensive experience in Immunology and late-phase clinical development≥ 7 years in clinical research or drug development (Phases I–IV). Phase 2 preferably≥ 3 years of global clinical trial execution experienceStrong knowledge of GCP, trial design, statistical methods, and regulatory processesAdvanced knowledge of assigned therapeutic areaExcellent communication, negotiation, and interpersonal skillsSeniority and Employment detailsSeniority level: DirectorEmployment type: TemporaryJob function: Research and ScienceIndustries: Pharmaceutical ManufacturingReferrals increase your chances of interviewing at SRG by 2x #J-18808-Ljbffr