Senior Operational Strategy Director

Overview

Senior Operational Strategy Director within Precision Medicine Group's Operational Strategy Department, driving operational strategy for RFPs, bid defense meetings (BDMs) and pre-award meetings, and leading projects that keep Precision at the forefront of innovation as a scientifically driven partner to biotech and pharma clients.

What you'll do

• Create, develop and refine the operational strategy for potential opportunities, including enrollment, feasibility, study timelines, startup timelines, relevant experience and competitive landscape.
• Collaborate with Feasibility colleagues to provide data-driven analysis supporting operational strategy, particularly country and site recommendations, competitive environment and projected recruitment rate.
• Develop proposal text describing the operational strategy and conduct a comprehensive proposal review prior to sponsor delivery, ensuring 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.
• Work with Project Management and Clinical Trial Management to transition the operational strategy approach ahead of opportunity BDM and support post-BDM follow-up items.
• Participate in the post-award engagement meeting to ensure the study team has the information and rationale behind the strategy position.
• Mentor and train Operational Strategy colleagues and Precision colleagues in aspects of strategy and budgeting for clinical research.
• Represent Precision for Medicine in client meetings, support capabilities presentations, and provide feasibility and competitive landscape direction input and support for BDMs using software and web-based applications.
• Create innovative solutions in conjunction with medical and scientific strategy, and provide consulting as needed for clients seeking input.
• Work with the Precision for Medicine team to support pre-award collaboration and inclusion of translational and data innovation strategies where appropriate.
• Represent the Company by attending industry meetings, speaking engagements and booth exhibitions, and by publishing scientific or industry-related articles in industry journals and digital media.

What you'll need

• Approximately 18 years in the CRO/Pharmaceutical industry or equivalent relevant experience and/or demonstrated competencies.
• Demonstrated competence and relevant experience in operational strategy analysis and budget review.
• Strong experience in Precision's identified target therapeutic area clinical development, focused on operational delivery considerations, strategy, feasibility, budget development and operational execution of all phases of clinical trials.
• Proven leadership and organizational skills.
• Strong oral and written communication skills.
• Strong rationale and analytical thinking.
• Strong ability to develop and review study budgets in alignment with study delivery strategy.
• Active listening and strong presentation abilities.
• Ability to collaborate with diverse stakeholders.
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and web/data-based platforms.
• Mastery knowledge of ICH-GCP, relevant Precision for Medicine SOPs and regulatory guidance.
• Numeric and financial management skills.
• Exceptional analytical and problem-solving skills.
• Strong attention to detail and ability to multitask to tight timelines while maintaining high quality standards.
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.

Nice to have

• Postgraduate degree.

Details

• Remote, United States.
• Domestic and international travel, including overnight stays, required.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.