Senior Feasibility Strategist

.pre {white-space: pre-wrap;} Your tasks and responsibilities

 

The primary responsibilities of this role, Senior Feasibility Strategist, are to:

 

  • Coordinate with Global Clinical Project Manager (GCPM), Global Clinical Leader (GCL) and other appropriate clinical and study team members to initiate the feasibility process as soon as the appropriate Clinical Development Plan (CDP)/Protocol elements (triggers) are available;
  • Lead the development of the feasibility plan through assessing the needs of the project and specific studies to define the end-to-end feasibility approach; This plan describes key feasibility activities and respective timelines and data requirements;
  • Own the feasibility plan and responsible for updating the plan regularly as required throughout the life-cycle of the study;
  • Act responsible for implementing the feasibility plan through developing appropriate action plans;
  • Ensure coordination and timely conduct of protocol and site feasibility assessments;
  • Ensure timely delivery of feasibility reports through proactive planning, appropriate delegation, thorough research and robust analysis and interpretations;
  • Meet and/or exceed customers’ expectations;
  • Assess the CDP/protocol elements including the trial objectives, design specifications, past therapeutic experiences and defines the depth and breadth of the research required;
  • Assess the needs for external (e.g. past performances, business/competitive intelligence, disease epidemiology) and internal data (e.g. past performance, strategic priorities) for each study, defines the data requirements and procures the data from the pre-selected preferred service providers;
  • Lead the analysis to generate an initial list of potential investigators and country allocation and site distribution based on past performances, competitive intelligence, availability of patients, incidence and prevalence, standard of care, organizational strategy and other relevant metrics as part of early indication feasibility and presents the list to the GCT;
  • Guide the GCT to select countries/sites suitable to conduct protocol feasibility;
  • With appropriate help from GCL, GCPM, StM and SME, lead the design of study specific protocol and site feasibility questionnaires and set-up eSurveys;
  • Develop training materials and provides training concerning all aspects of the feasibility processes;
  • Lead scenario analysis using internal and external data with appropriate modelling tool to develop alternate scenarios with optimal site and country distribution based on robust data-driven rational. Identifies potential strategic (e.g. cost, timelines) operational (e.g. resource and start-up time) impact for each scenario and develop contingency plans;
  • Analyze survey responses and review recommendations received from external vendors and consolidate all data to formulate data driven and informed protocol and site feasibility recommendations; The report includes, but not limited to, an updated list of investigators, scenarios, recommendations on protocol design and potential strategic and operational challenges to execute the protocol; The reports should reflect an in-depth understanding of country, site and investigator profiles, standard of care, past performances, operational infrastructures of sites, availability of targeted patients, barriers to recruit and opportunities;
  • Share feasibility findings in meetings and handles clarifying questions and influences discussions;
  • Ensure appropriate and timely communications throughout the process with all the stakeholders;
  • Ensure that the information hub is fit-for purpose; To enable this it is important that the feasibility strategist makes regular recommendations to enhance capability of ‘Bayer Feasibility Information Hub’ through regular monitoring of industry trends, regulatory requirements, technological advances, proactive scouts and evaluations of new technologies and novel site intelligence data from external and internal sources;
  • Work closely with internal functions to ensure that site performance, recruitment metrics and benchmark data are systematically collected, stored and utilized regularly;
  • Provide oversight to team members in execution of their responsibilities thought the feasibility process;
  • Support the Head of Feasibility Excellence group to develop and implement visions, manage changes and continuously improve the feasibility processes and ‘Information-Hub’;
  • Recruit, train, coach and motivate feasibility strategists, analysts and other colleagues.

 

.pre {white-space: pre-wrap;} Who you are

 

Your success will be driven by your demonstration of our LIFE values (Leadership, Integrity, Flexibility, Efficiency). More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

  • M.D., Ph.D., M.Sc., or M.A. degree with minimum of 5 years Pharmaceutical industry experience, OR Bachelor’s degree with minimum of 8 years Pharmaceutical industry experience;
  • Minimum of 4+ years’ experience in data driven feasibility assessments, protocol synopsis assessment, site identification, patient enrollment forecasting and modeling;
  • In-depth understanding of the clinical development and operations and commercialization process, regulatory requirements and guidelines (e.g. ICH, GCP) with previous direct clinical development experience in an international setting within a similar role;
  • Deep understanding of clinical trial and site performance metrics;
  • Ability to define the internal and external data requirements to conduct data driven feasibility, design research methodology to conduct primary and secondary research;
  • Ability to build/select appropriate analysis techniques, quantitative models and present analysis findings effectively to the team;
  • Ability to formulate recommendations/generate insights from complex analysis – identifies the implications, “the so what”, from the analysis;
  • Strong communication, coordination and negotiation skills to ensure that accurate and concise feasibility reports developed using inputs from functions and internal and external experts;
  • Proven leadership ability of virtual teams and strong motivational and interpersonal skills;
  • Ability to execute responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively.

     

This position will provide relocation assistance within the U.S.  Preferred location is Whippany, NJ.

.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.