Senior Operational Strategy Director

Position Summary:

The Senior Operational Strategy 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 Senior Operational Strategy Director will support the business development team by representing Precision operations at pre-award meetings. In addition, this team member will 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:

• 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:

• 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.

Other Required:

•  Approximately 18 years in the CRO/Pharmaceutical industry or equivalent relevant experience and/or demonstrated competencies.
• Demonstrated competence and 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:

•  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.
• Able to collaborate with diverse stakeholders.
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms. 

Competencies:

• Exceptional analytical and problem-solving skills
• Highly organized with excellent interpersonal, presentation, oral and written communication skills
• 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. 

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Reasonable estimate of the current range 202400 - 304800 USD