Pulmovant

Head of Clinical Operations

Pulmovant

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

About the role

  • Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO/vendor selection, contracts & budgets, CRO/vendor oversight, and proactive risk management to ensure the quality conduct of trials with a high level of quality and data integrity
  • Responsible for the successful planning and execution of Phase 2 and 3 trials
  • Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement
  • Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals
  • Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs
  • Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; heavy emphasis on late-stage development experience
  • Develops and optimizes critical SOPs needed for program success, inspection readiness and compliance
  • Oversee identification, qualification, and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders with CRO
  • Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
  • Provide scientific/clinical expertise in the design and interpretation of clinical studies
  • Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
  • Provide direct line management and training/mentoring of Clinical Operations team members
  • Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness
  • Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
  • Create and oversee clinical program budget(s) and long-range clinical planning/forecasting activities
  • Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed
  • Contribute as required to the authoring of key regulatory documents, study protocols, investigator’s brochures, IND reports, study postings, ensuring document and operating standards are established and maintained
  • Participate in business development and process improvement/quality initiatives, as needed

Requirements

  • Bachelor's Degree in a scientific discipline; with a minimum of 12-15 years clinical development experience.
  • Extensive clinical operations management experience, including program leadership or TA leadership at a minimum
  • Proven excellence in clinical operations strategy and execution, including Ph I-IV studies, global clinical trial operations, and multiple clinical trials simultaneously. Experience in Respiratory/Pulmonary diseases preferred
  • Hands-on, detail-oriented leader with operational fluency
  • Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills
  • Experience in building infrastructure (including SOPs) required
  • Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy. Strong coaching and mentoring skills leading to the success and development of subordinates
  • Willingness/ability to travel (domestic and international)
Benefits
  • Equal employment opportunities for all employees and applicants without discrimination
  • Prohibits discrimination and harassment of any type

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical operations strategyclinical trials executionCRO/vendor selectionrisk managementSOP developmentbudget managementregulatory complianceclinical study designprogram leadershipclinical development experience
Soft skills
leadershipproblem-solvingtime managementnegotiationorganizational skillscollaborationanalytical thinkingcoachingmentoringgoal setting
Certifications
Bachelor's Degree in a scientific discipline