- Lead the development of the marketing feasibility plan through assessing the needs of the project and specific studies to define the end-to-end feasibility approach. (includes key feasibility activities, timelines and data requirements) Provide insights on challenges and opportunities as well as a set of recommendations to inform the recruitment strategy
- Evaluate 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, and procures the data from service providers and databases
- Assess country and therapeutic elements of the study including past therapeutic experiences, comorbidities, prevalence/incidence, country health systems standards of care, cultural norms, medical influencers and media utilization and informational search behaviors as well as competitive clinical studies in the geographic area and defines the depth and breadth of the research required
- Co-Lead with Clinical Research Analyst the analysis to generate an initial list of 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
- Develop an analysis from all data insights to formulate market feasibility recommendations; The report includes, but not limited to, general disease state information, an updated list of countries based on prevalence/incidence, updated list of country/therapeutic challenges, competitive studies, media restrictions, advocacy partnerships, Physician type/role in decision making, strategic and operational challenges to execute the protocol; The reports should reflect an in-depth understanding of availability of targeted patients, barriers to recruit and opportunities.
- Oversee country, therapeutic, marketing landscape assessments (standard of care, media channels and utilization, country attitudes toward clinical trials, language/country nuances, prevalence/incidence)
- Identify and enable utilization of centrally derived data sources to support program/study teams in obtaining insights and making data driven decisions
- Identify and leverage external knowledge of industry best practices, processes and current trends
- Ensure timely delivery of feasibility reports through proactive planning, thorough research and robust analysis and interpretations;
- Develop, maintain and share marketing and therapeutic assessment of international country healthcare systems, cultural attitudes and beliefs, media utilization, and assess developments for impact on study design and execution
- Liaison with Site Network to validate country knowledge and trends, insure country requirements are captured and integrated
- Works closely with the project teams for development of patient recruitment plan and coordination of activities to optimize site and patient engagement for clinical trials.
- Bachelor's degree (marketing, health care or scientific discipline)
- 3-5 years' experience in pharmaceutical industry, clinical trial information support or relevant experience preferred
- Global experience ideal
- Minimum of 3+ years' experience in data driven feasibility assessments,
- In-depth understanding of the patient recruitment, country marketing requirements, clinical operations and commercialization process,
- Deep understanding of marketing research and analysis
- Strong analytical competencies. Exposure to, and understanding of, epidemiological, healthcare, commercial, real world and clinical data sets as it relates to clinical trial planning and execution.
- Understanding of clinical trial processes, working with clinical, real-world data and KOL/VOC insights
- Work with various regions and cultures to share knowledge
- Ability to define the internal and external data requirements and design research methodology to conduct primary and secondary research
- Capability to formulate recommendations/generate insights from complex analysis - identifies the implications and present analysis findings effectively to the team;
Additional skill set:
- Ability to adjust to changing priorities, manage multiple projects and tasks in a fast-paced environment.
- Attention to detail and organizational skills, consultative attitude
- Excellent communication, coordination and negotiation skills to ensure that accurate and concise feasibility reports developed using inputs from functions and internal and external experts
- Ability to execute responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively.
Other: Computer work for long periods of time
This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.