Operational Strategy Director - Clinical Trials

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 stages—from early development through approval—with 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. Won’t 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 Trial Management to transition the operational strategy approach ahead of opportunity BDM and support in 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 client meetings
  • Provide feasibility and competitive landscape direction input, and support for BDMs utilizing software and web-based applications.
  • Create innovative solutions in conjunction with medical and scientific strategy, and provide consulting, as needed, for clients who are seeking input. 
  • Work with Precision for Medicine team to support pre-award collaboration and inclusion of translational and data innovation strategies where appropriate, to help optimize Precision impact.
  • Represent the Company by attending industry meetings, speaking engagements, booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals and digital media.

Qualifications:

Minimum Required:

• Advanced degree in a life sciences discipline or equivalent relevant experience

Other Required:

• 15+ years in the CRO/Pharmaceutical industry or equivalent relevant experience and/or demonstrated competencies.
• Relevant experience in the required activities for the role including 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.

Preferred

• Postgraduate degree preferred.

Skills:

• Strong leadership and organizational skills
• Strong oral and written communication skills in English
• 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.
• Able to collaborate with diverse stakeholders.
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms.

Competencies

• Strong sense of ownership and pride in quality of outputs.
• Strong attention to detail.
• Ability to multitask to tight timelines prioritizing workload and maintaining high quality standards.
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Accomplished at maintaining a sustained focus at the macro level while being able to manage at the micro level as needed.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective in delivering results with appropriate quality and timeline performance.
• Numeric and financial management skills.
• Embraces and embodies the established Precision for Medicine’s Cultural Values as an underlying tenet to drive work behaviors.
• Demonstrates mastery knowledge of ICH-GCP, relevant Precision for Medicine’s SOPs and regulatory guidance.
• Ability to work as part of a team.

Travel required

• Domestic and international travel including overnight stays

 #LI-KH1 #LI-Remote