Travere Therapeutics

Travere Therapeutics

Associate Director, Clinical Operations

San Diego · Director

Sponsorship not specified$10k-$20kDetected 14 hours ago
Operations ManagementLogisticsClinical TrialsClinical ResearchPharmacologyResearchLeadershipCommunicationCollaborationMentoringPublic SpeakingOrganizational SkillsMicrosoft Office

About the role

  • The Associate Director, Clinical Operations is accountable for the execution and on-time delivery of milestones for Phase 1 clinical pharmacology clinical trials (e.g. FIH, SAD/MAD, DDI, QTc, Human ADME, food effect).

Responsibilities

  • Lead operational execution of Phase 1 Clinical Pharmacology studies.
  • Manage operational aspects of DDI, food effect, BA/BE, QTc, and organ impairment.
  • Partner with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical group.
  • Drives key SMT deliverables in line with approved program timeline.
  • Provides daily oversight and support of Clinical Operations representatives in leading the SMTs and assigned areas.
  • Provides guidance and support to the various SMT members to ensure SMT activities are delivered per the overall clinical operations plan for assigned study(ies).
  • Provide input into clinical study documents with a focus on operational feasibility review of intensive sampling schedules, confinement logistics, and crossover study designs (e.g., clinical study protocol, ICF templates, study plans/tools, and site-facing materials such as site budgets, recruitment material, etc).

Requirements

  • Bachelor's degree in life sciences, nursing, pharmacy or related discipline required.
  • 8+ years of progressive clinical trial experience including at least 2 years in a leadership role overseeing the execution of clinical trials or programs required.
  • Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH E6 (R2) GCP.
  • The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.

Nice to have

  • Driven, intelligent, passionate about making a difference for patients with rare diseases.
  • Ability to think analytically to quickly triage multiple solutions to an issue and determine best path forward.
  • Should have strong skills in MS Office and timeline software such as MS Project or Smartsheet.
  • Experience with clinical systems such as IRT, eTMF, etc.
  • Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
  • Demonstrates excellent understanding of cross functional activities and input into clinical studies.
  • Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, and respond to situations affecting staff preferred.
  • Ability to travel 10-20% domestic and internationally.

Compensation

  • Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
  • Target Base Pay Range:
  • $150,000.00 - $195,000.00
  • This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Benefits

  • Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
  • Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Equal opportunity

  • If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com.
  • Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only.
  • Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
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