Senior Clinical Project Manager
Alimentiv
PMP
Senior Director, Clinical Operations
Dianthus Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Oversee and direct relevant clinical operations resources while also contributing to strategy, tactics, and driving execution of multiple global clinical programs.
- Influence, oversee and lead the planning, budgeting, and study management processes in global clinical studies.
- Leads direct reports to successfully manage external service providers including CRO(s), vendors and subcontractors, in addition to internal cross-functional colleagues responsible for conducting global clinical trials to ensure project deliverables are executed on time and within budget.
- Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
- Creates/supports scenario planning and risk benefit analyses to make recommendations to align with corporate strategies.
- Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in department.
- Review, assess and manage resource strategies with internal and external groups for global drug development programs, working strategically with suppliers/CROs.
- Manage relationships with pharmaceutical partners and suppliers in clinical programs to optimize delivery.
- Ensures efficient and effective communication and exchange of information across projects and reporting functions.
- Leads/participates in clinical data review.
- Participates in Clinical submission activities.
- May serve as the clinical operations representative at regulatory agency meetings.
- As needed, participates in due diligence activities for in-licensing opportunities.
- Develop training plans, act as mentor and conduct performance reviews for all direct reports.
- Supports the development and implementation of department level SOPs for clinical trials and related activities.
- Interface with departments within and outside of Clinical, including Finance, Regulatory Affairs, Legal Affairs, and Business Development.
- Represent the company at Investigator Meetings.
Requirements
- Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advance degree desirable.
- Experience in the pharmaceutical or biotechnology industry as a clinical research professional, including successful project leadership role and hands-on managerial experience running high-quality clinical trials from inception to completion.
- Excellent knowledge of international regulatory and ICH GCP guidelines.
- Experience in direct line management and hands-on experience in monitoring and managing high-functioning clinical trial project teams.
- Demonstrated success in coordinating external resources for clinical development and in working with pharmaceutical partners.
- Demonstrated ability to manage large complex budgets.
- Experience and understanding of the drug development process, clinical development planning and clinical trial execution.
- Understanding of clinical aspects of therapeutic area along with willingness to develop in-depth expertise.
- Prior experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, IVR/IWRS, CTMS).
- Ability to work well independently as well as a member of multiple, integrated teams.
- Ability to contribute creative yet practical solutions to problems.
- Ability to multi-task and manage several projects in parallel while paying attention to detail. A wide degree of creativity and latitude is expected.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
- Highly effective verbal and written communication skills with internal and external stakeholders.
- Effectively collaborates with team members.
- Ability to travel (including internationally) and work across cultures.
Benefits
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementproject leadershipbudget managementclinical development planningdrug development processrisk benefit analysisperformance measurementscenario planningclinical data reviewregulatory compliance
Soft skills
leadershipcommunicationproblem-solvingcollaborationindependent workmulti-taskingattention to detailcreativitymentoringrelationship management
Certifications
Undergraduate degree in Life SciencesRN degreeadvanced degree (desirable)
