Senior Operational Strategy Director
New
P
Precision for MedicineClinical trials
Remote, United StatesFull-TimeDirector
Salary$202,400 — $304,800 USD
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Job Details
- Experience
- Approximately 18 years in the CRO/Pharmaceutical industry or equivalent relevant experience and/or demonstrated competencies.
- Required Skills
- Data AnalysisMicrosoft ExcelPowerPoint
Requirements
- Approximately 18 years in the CRO/pharmaceutical industry, or equivalent relevant experience and/or demonstrated competencies.
- Demonstrated competence in operational strategy analysis and budget review.
- Strong experience in the identified target therapeutic area, including clinical development, operational delivery, strategy, feasibility, and budget development.
- Experience with operational execution across all phases of clinical trials.
- Proven leadership and organizational skills.
- Strong oral and written communication, presentation, active listening, and collaboration skills.
- Strong analytical thinking, problem-solving, and attention to detail.
- Ability to develop and review study budgets in alignment with study delivery strategy; numeric and financial management skills.
- Strong computer skills, including MS Word, Excel, PowerPoint, and web- or data-based platforms.
- Mastery knowledge of ICH-GCP, relevant Precision for Medicine SOPs, and regulatory guidance.
- Ability to work independently and in a matrix team environment, manage competing priorities, and meet tight timelines.
- Postgraduate degree preferred.
Responsibilities
- Develop and refine operational strategies for potential opportunities, including enrollment, feasibility, study timelines, startup timelines, relevant experience, and competitive landscape.
- Collaborate with Feasibility colleagues on data-driven country and site recommendations, competitive analysis, and projected recruitment rates.
- Develop proposal text describing operational strategy and conduct comprehensive proposal reviews before sponsor delivery.
- Ensure proposals reflect strategic, operational, scientific, medical, and clinical development planning.
- Create and refine study budgets and support budget development and finalization with functional leadership.
- Coordinate with Project Management and Clinical Trial Management to transition operational strategy before bid defense meetings and support follow-up.
- Participate in post-award engagement meetings to explain the study strategy and its rationale to the study team.
- Mentor and train colleagues in operational strategy and clinical research budgeting.
- Represent Precision for Medicine in client meetings, capabilities presentations, industry meetings, speaking engagements, and publications.
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