Director Clinical Operations
We’re partnering with a growing pharma company advancing a clinical-stage pipeline. They are seeking a Clinical Director to provide medical and scientific leadership across their portfolio of programs.Key ResponsibilitiesLead the design and execution of clinical development plans across Phase I–III studiesProvide medical oversight and strategic input into clinical trial design, endpoints, and patient populationsContribute to overall program strategy and decision-making at the leadership levelOversee clinical trials to ensure scientific integrity, patient safety, and operational excellenceReview and interpret clinical data to inform ongoing development decisionsPartner with Clinical Operations to ensure timelines, budgets, and deliverables are metServe as Medical Monitor for clinical studies (as needed)Review safety data, adverse events, and support safety signal detectionCollaborate with Pharmacovigilance on safety strategy and reportingProvide clinical input into regulatory submissions and health authority interactionsSupport development of key documents (protocols, IBs, CSRs, briefing packages)Represent the company at investigator meetings, advisory boards, and conferencesLead data review meetings and contribute to interpretation of clinical resultsPresent clinical data internally and externally to stakeholdersProvide clinical risk assessment and competitive landscape insightsRequired QualificationsMD (or equivalent medical degree) required8–12+ years of clinical development experience in biotech/pharmaExperience in clinical trial design and execution (Phase I–III)Prior experience serving as Medical Monitor Strong understanding of GCP and clinical regulatory requirementsExperience working cross-functionally in a drug development environmentAbility to interpret clinical data and translate into strategic decisionsStrong communication and stakeholder management skillsPreferred QualificationsBoard certification or clinical practice experience in a relevant therapeutic area (oncology, CNS, rare disease)Experience leading clinical programs in a mid-sized or growing biotech environmentDirect interaction with regulatory agencies (FDA, EMA)Experience contributing to regulatory submissions (INDs, NDAs, BLAs)Track record of advancing programs through key clinical milestonesPrior involvement in KOL engagement and external scientific communicationExperience supporting business development or due diligence activities