Head of Feasibility

Job Title: Head of Feasibility

Location: Swiftwater, PA

About the Job

The Head of Feasibility (HF) is responsible for developing winning country, site, patient, and data strategies to ensure the platform’s operational success with adherence to study timelines. In this role you will provide expert guidance on country and site selection strategies, regulatory considerations and start-up timelines, as well as patient access considerations, using operational experience, clinical trial knowledge, real-world data (RWD) and predictive analytics, thus ensuring efficient, accelerated and successful operational delivery. You will oversee the design of each therapeutically customized site identification and patient strategy with the start-up team, collaborates with Project Management Leads, Clinical Trial Management, as well as drug development experts, to ensure that the overarching strategy is operationally realized within the agreed upon timelines and budgets. You will apply an objective and data-driven approach to significantly influence the functional strategy, designed to give the competitive edge.

The Head of Feasibility will exhibit an in-depth understanding of emerging use of real-world evidence (RWE) and predictive analytics; demonstrate an ability to discover, evaluate and/or recommend innovative data-driven approaches; and a willingness to explore ground-breaking technologies in RWE, AI or other spaces, ensuring is the global leader in feasibility.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Vaccine Strategy and Coordination

As a member of Global Clinical Study Management Team:

• Knowledgeable about overall R&D and Franchise strategy for Sanofi Vaccines; understands the implications of the strategy for Clinical Programs.

• Provides relevant, knowledge and insights to support the development of the Global Platform strategy; provides specific information and insights.

• Actively engages in decision-making process with other Platform Management Team members, providing input as needed to Global Platform Head. As appropriate, also works with CPMT members and colleagues across Clinical R&D, to support cross-functional problem solving and decision-making.

• Ensures proactive, timely reporting on progress of operational components of clinical trials and communicates operational opportunities and risks to the Global Platform; openly raises issues that require input from and discussion with other members of the global platforms and addresses questions from colleagues.

• Stays abreast of the needs of partners and key stakeholders and works with other CPMT members to create integrated plans for collaborating effectively with partners and stakeholders and ensuring optimal delivery of clinical studies.

• Provides regular, up to date, consistent and accurate reports on operational components of ICH-GCP compliance, quality standards and regulatory considerations for his /her platform.

Leadership / Management

• Leads and manages a Study Startup team within the CSM platform.

• Manage team members of a global and multicultural platform; 8+ direct reports, 5 indirect reports, plus outsourced resources.

• Focuses on developing skills and capabilities that support strategic goals and objectives of the function, including alignment with the GCD organization.

• Attracts, motivates and retains qualified staff to ensure the attainment of GSM platform objectives.

• Manage team members of a global and multicultural platform; 8+ direct reports, 5 indirect reports, plus outsourced resources.

• Negotiates for her/his assigned programs, resources (FTEs and funding) to meet the clinical requirements of the clinical programs/projects in order to ensure the timely and efficient meeting of the program or project clinical milestones.

• Provides regular one-to-one time with his/her direct reports to discuss project-related and non-project related (development, performance feedback) matters.

• Supports his/her direct reports with definition of annual objectives, ad performs mid-year and end-year performance evaluations.

• Actively engages in decision-making process with the Management Team, providing input as needed to the Global Head of the CSM platform.

Communication / Interfaces

• Team Communication: Foster teamwork by communicating openly, balanced, and objectively with the team.

• Drives and consolidates key communication and meaningful reports for his / her team and maintains cross functional communication.

• Acts as an interface between CSM Platform and GCD or, by delegation, other enabling functions such as GRA, GPV, CM&QO, GMA, FPRM and GCI, especially in the context of issues resolution on his/her Team assigned projects.

• Ensures clear and timely information is shared between projects/programs, Clinical Teams and Management.

Coordination of Study Start-up Activities

• Real World Data and predictive analytics: Identification of the processes and systems required to enhance the data-driven approach and work to define the way of working and generating standardization among study start up team.

• Recruitment and Screening: Assist with the creation and review of recruitment and screening documents for clinical team and relevant boards and committees for approval. Ensure standards are applied to the study startup process across project portfolios and support continuous improvement

• Recruitment Effectiveness: Assist with the analysis of recruitment effectiveness.  

In reviewing the feasibility, ensure the teams output by:

• Provide accurate projections and timelines to study teams based upon country's historical performance

• Report progress and feasibility challenges in trials. Identify potential risks to timelines and results and manage issues independently.

• Monitor start up activities to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual.

• Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.

• Guide the collection and analysis of all data to influence study startup timelines.

• Establish, developing, and delivery of the Global Study Startup Project Plan.

• Provide information on local regulatory guidelines to project team ensuring projects are conducted.

• Provide support and recommendations to project team in resolving local issues.

• Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation.

• Coordinates the start-up deliverable of assigned studies (Including overall accountability for delivery to time, cost, and quality etc.)

Planning / Resources / Budget / Risks

• Ensures appropriate capacity /resource planning and management in conjunction with other functions within GCD and Clinical R&D.

• Ensures that her/his Team allocated projects/programs operational strategy are delivered on time, within budget with adequate resources by regular review budget and resources allocation for her/his Clinical Franchise.

• Ensures that risks are properly identified and managed for her/his Team allocated projects/programs.

Context of the job/major challenges

• Process Improvement: As a manager, create a culture of process improvement focused on streamlining processes, adding value to the business, and supporting the broader organizational needs.

• Department Leadership: As the Head of C3S, ensure the department has a well-organized infrastructure and adequate resources to complete projects on time and within budget.

• Expertise and Consultation: Provide expertise, facilitate metrics collection, and develop action plans with project leaders and other functional leaders to keep projects on track.

• Process Implementation: Implement process improvements based on corporate metrics, client feedback, and team feedback.

• Partner Management: Manage partners providing clinical informatics technologies or services as needed.

• Committee Participation: Participate in committees and task force groups as requested by functional and executive leaders.

• Team Development: Develop a team, ensure compliance with training curriculum, career development, and performance management. Conduct advanced process management within the Feasibility function.

• Excellence in Life Sciences: Drive excellence in applied life sciences, real-world evidence, and bioinformatics services in drug development by adopting new information resources and validating forecasting and

 Dimensions/Scope

• Provide numerical data if available to describe the size of the job, or its impact on the business. Use annual figures and specify currency. Figures should include budgetary responsibility, purchasing authority, resources available. Highlight the key decisions made in this job. Outline the sphere of the job, such as whether the accountabilities are global, country specific, or function specific.

• The HF provides oversight of activities in the planning, feasibility and execution of clinical trials design through daily management of C3Ss. Is responsible for project assignments, coaching, mentoring, talent management and performance reviews for C3Ss. The HF serve as a key interface between the Global Clinical Deveopment teams and external platforms i.e. the Franchises/CTLs & CSs, PPFP, R&D Procurement, and Legal Dept. to ensure appropriate communication on planned clinical trials/program timelines and resource needs. Must proactively monitor the achievement of project key milestones (PKMs) and Clinical Key milestones (CKMs). Therefore, this position will have direct impact on study design & planning to investigator selection, and impact on clinical budgets and successful achievement of clinical project milestones.

About You

Education and Experience

• Bachelors degree in relevant field

• 12 years or greater experience in vaccinology or clinical research

• People management experience preferred

• Formal training in GCP methods

• Proven track record in delivering high quality GCP-compliant Clinical Trials

• Clinical Trial experience preferred

• Knowledge of Code of Federal Regulations (US) and regulatory agency documents

• Demonstrated interpersonal skills - ability to work with individuals at different levels

• Independent, self-motived and results oriented

• Demonstrated team and negotiation skills

• Resourcefulness; ability to find solutions to operational problems

• Project management, budget management experience required

• Knowledgeable in real word evidence/epidemiology

• Coordinates the start-up deliverable of assigned studies (Including overall accountability for delivery to time, cost, and quality etc.)

Why Choose us

• Bring the miracles of science to life alongside a supportive, future-focused team.​​

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.​

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SP ​
#LI-SP    

#LI-Onsite
#vhd