Operational Strategy Director - Clinical Trials
Remote, United States
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stagesâfrom early development through approvalâwith embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Wonât you join us today as a Operational Strategy Director, Clinical Trials?
Position Summary:
The Operational Director will be a core member of the expert team within Operational Strategy Department of Precision for Medicine. As part of this team, they will drive and support the operational strategy considerations for the RFPs, bid defense meetings (BDMs) and support the operational teams at BDM. This will entail drawing on strong experience of operationalizing complex clinical studies globally, knowledge and analysis of the competitive environment and analysis of the study design and rationale. The Operational Strategy Director will support the business development team by representing Precision operations at pre-award meetings. In addition, this team member may lead specific projects that will enable Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.
Essential functions of the job include but are not limited to:
- Provide operational strategy input, text and budget review for proposals:
- Collaborate with medical, operational, business development, proposal colleagues and other Precision functional leadership as required to:
- Create, develop, and refine the strategy for potential opportunities specifically regarding operational considerations such as enrollment, feasibility, study timelines, startup timelines, relevant experience, competitive landscape.
- Collaborate and work closely with colleagues from Feasibility to provide data driven analysis to support the operational strategy, particularly with respect to country and site recommendations, competitive environment and projected recruitment rate.
- Develop proposal text that describes the operational strategy and conduct a comprehensive proposal review prior to sponsor delivery.
- Ensure proposals reflect robust strategic, operational, scientific, medical and clinical development planning.
- Create and refine study budgets and support the development and finalization of study budgets for potential opportunities in partnership with other functional leadership as necessary.
- Work closely with colleagues in Project Management and Clinical âŚ
- Collaborate with medical, operational, business development, proposal colleagues and other Precision functional leadership as required to:
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Annual bonus Disability benefits Discretionary annual bonus Health insurance Life Insurance Life insurance and disability benefits Paid Time Off Paid time off for sick leave and vacation Parental leave Retirement savings Retirement savings benefits
Tasks- Business development
- Consulting
- Develop proposals
- Drive operational strategy
- Mentor colleagues
- Project management
- Support business development
Analytical Analytical thinking Attention to detail BioTech Budgeting Business Development Client Engagement Clinical Development Clinical operations Clinical Research Clinical Studies Clinical Trial Management Clinical trials Collaboration Communication Competitive analysis Continuous Improvement Data analysis Data sciences Excel Financial Management GCP ICH Laboratory expertise Leadership Life sciences Management Mentoring MS Word Oncology Operational strategy Organizational Pharma Pharmaceutical Industry PowerPoint Precision Medicine Presentation Project Management Proposal Development Rare Disease Recruiting Regulatory Guidance Research and development SOPS Study Design Training Word Written communication
Experience5 years
EducationAdvanced degree Business Degree Equivalent Life Sciences MS Postgraduate Postgraduate degree Scientific
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9