Vice President, Strategy & Optimization

JOB SUMMARY

The Vice President (VP), Study Strategy & Optimization is responsible for driving and overseeing Strategy & Optimization. The primary focus for this role is on strategic direction for clinical trial optimization, including leading the team that develops clinical development strategy, feasibility, site engagement and patient engagement strategies and sells/delivers the company feasibility and patient engagement services. Oversight and operational activities include, but are not limited to, staffing and staff development/training, financial forecasting, budget planning and P&L management, procedures and process as well as support of business development and marketing activities. This role has direct reports within Strategy & Optimization and serves as part of the leadership/management team. This role requires both strategic and tactical capabilities, execution, excellence in business processes and innovation in problem solving and business growth initiatives. The scope of responsibilities includes leadership, policy-making, global infrastructure development, personnel development, training and oversight, support of execution of projects within the function and meeting all time frames and targets to the internal and external client's satisfaction. In addition, the VP, Study Strategy & Optimization is responsible for the execution of the scope of work, objectives, the quality of deliverables, and other components of clinical development strategy, feasibility and patient engagement execution, which may be multi-regional or international in scope.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Oversee all aspects of study optimization, including clinical development strategy, global feasibility services, patient engagement services, and site engagement execution.
• P&L management of the functional area with Strategy & Optimization
• Day-to-day performance management and skills development of specific department employees within Strategy & Optimization.
• Develop and execute strategy for continuing cross-departmental collaboration and company growth and provide hands-on leadership to create a results-orientated, internal and external client focused and team environment.
• Strategically design, plan and oversee implementation of clinical development strategy, patient engagement, feasibility and site engagement programs to position Advanced Clinical as a trustworthy leader within the industry and with internal stakeholders.
• Lead functional team to devise strategic plans, enhance processes and execute across clinical development strategy, feasibility, site engagement and patient engagement to successfully:
  
  
  
  • Execute pre-award and post-award feasibility and patient engagement assessments/projects
  • Oversee development, integration, expansion and further development of the clinical development strategy role and function, including plans, standard processes, roles/responsibilities, deliverables and expectations
  • Develop processes and provide guidance on best practices for approach across all service lines
  • Serve as the functional subject matter expert with internal and external stakeholders
  • Serve in primary role and mentoring functional team members to support new business opportunities, including proposals and bid defense meetings
  • Lead budgetary standards and marketing efforts for feasibility and patient engagement functions
  
  
• Routinely assess tools, subscriptions, vendors, etc. related to function, including but not limited to: patient engagement, feasibility, site engagement, DCT, RBQM and other applicable areas related to clinical development strategy to ensure efficiencies are recognized while maintaining industry leading strategy and solutions.
• Develop strategy for a formalized DE&I and Site Engagement Program(s), including site and PI relationships for Advanced Clinical to offer our customers. Also responsible for tracking and reporting in order to ensure global, therapeutic, and diverse population coverage.
• Serve as the functional area leader and support the functional team in Business Development and Sponsor presentations and meetings (i.e. capabilities meetings, bid defense meetings, feasibility findings meetings, feasibility report presentations, etc.).
• Responsible for overseeing process and optimization of cross-functional participation with clinical operations, regulatory, study start-up, medical, data management, biostatistics and other relevant functions participating in the clinical strategy, feasibility, patient engagement and site engagement process.
• Oversee execution on pre-award and paid feasibility and patient engagement assessments and consult for strategic and/or key accounts as needed.
• Lead and/or participate in strategic initiatives to enhance or refine service offerings, process and/or for purposes of corporate growth.
• Responsible for achieving study optimization set goals and financial targets.
• Prepare and implement the Study Optimization department's annual budgets and review and approve all respective department staff expense reports and timesheets, as well as invoices payable up to the agreed monetary limit.
• Accountable for customer satisfaction related to Study Optimization deliverables.
• Develop, track and monitor functional KPIs to represent contribution to overall corporate goals.
• Oversee all aspects of Study Optimization department including resource planning, deliverables, staff training, staff appraisals, performance reviews, and annual salary reviews.
• Initiate, lead, and develop strategic business growth initiatives, technology solutions, and or process improvements that improve efficiencies and global company growth.
• Attend and train Study Optimization team members to attend RFI/RFP proposal strategy meetings and operationally lead strategy development and approve proposals and budgets.
• Develop departmental SOPs and ensure staff adherence to company policies, SOPs, guidelines and GCPs.
• Adhere to strict code of confidentiality as it relates to study subjects, sponsors, physicians and policies and procedures.

QUALIFICATIONS

• Minimum 12 years of professional experience in Clinical research and/or Drug Development, with at least 10 years in direct Feasibility, Patient Recruitment/Engagement and/or Clinical Strategy experience. Experience should include working knowledge of study management logistics, medical management and protocol design, patient recruitment/engagement, regulatory/start-up logistics, trial design, country-level nuances and robust protocol, country and site feasibility assessment conduct. Experience within a CRO preferred.
• In-depth knowledge regarding the drug development process, operational clinical trial management and challenges within clinical research required.
• Knowledgeable of frequently utilized systems in the pharmaceutical/clinical research/CRO industry.
• Must be able to see the "big picture" and project manage to the detail.
• Excellent communication and presentation skills, including written, spoken and listening skills.
• Demonstrated ability to work in a fast-paced environment.
• Demonstrated leadership ability, including experience in customer and industry meeting presentations.
• Must have a positive demeanor with strong problem analytic and problem-solving skills.
• Exceptional ability to consult and collaborate with individuals across various levels of the organization, as well as individuals across all levels outside of the organization.
• Computer skills, including Power Point, Excel and frequently utilized business intelligence tools (i.e. Citeline, Claims Databases, Impact Assessment Tools, etc.)

ROLE COMPETENCIES

• Established internal and external reputation as a credible, trustworthy professional and clinical strategy, global feasibility, patient and site engagement subject matter expert in order to execute, enhance sales, and serve as a resource to guide cross-functional teams as it relates to study optimization.
• Proven leader with the ability to transparently communicate with internal and external stakeholders to ensure project milestones and goals are achieved.
• Extensive experience and understanding of multiple therapeutic areas, with flexibility and willingness to apply therapeutic knowledge and training to areas of non-specialty, study designs, clinical trial development strategy and feasibility strategy and execution.
• Tenacious and self-motivated to uncover information outside of analytical tools/software to support and guide the functional team in feasibility findings and outputs.
• Mastery of the skills and knowledge relevant to the function. Significant success in performing the most demanding assignments under no supervision.
• Proactively discovers the needs of customers and creates solutions to meet the customer's changing needs. Works in partnership to improve customer experience.
• Communicates broadly and strategically with complex issues and communicates project and goal status clearly and credibly with widely varied audiences. Ensures appropriate individuals are informed.
• Develops alignment from cross-functional teams to drive projects, process and functional goals. Facilitates discussions and considers a range of interests, opinions, possibilities and situational variables.
• Demonstrates awareness, flexibility and willingness to adapt approach and/or apply different leadership styles when the situation or individual requires it.
• Champions department programs and projects to meet the changing needs of Advanced Clinical and our customers. Remains informed on customer needs and industry trends to ensure integration into organizational priorities.
• Links strategy to a series of clearly actionable initiatives, programs and procedures.
• Translates strategic goals into clear departmental programs and projects. Develops short- and long-term plans and incorporates cross departmental input to generate plans.
• Introduces changes in direction, policy, or procedure. Brainstorms and resolves issues in organizational process efficiency. Uses facilitation tools and techniques to stimulate creative thinking and discussion at all levels.

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).