Summary
The Senior Manager, Global Trial Optimization (GTO) will lead program or study level activities to inform the clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies.. They will play a key role in developing and maintaining relationships with external experts to facilitate a wide source of country and disease area intelligence that can be utilized in study design and operational planning.
Responsibilities
Essential Functions required for the job. List both technical and managerial requirements if applicable.
- Lead study level feasibility processes to generate high quality and timely data to inform study design, optimal geographical placement, and operational planning.
- Partner with teams during CRO led feasibility activities to support validation of study and country level enrolment rates and study start-up timelines to inform budget and baseline setting.
- Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management activities.
- Partner with Data and Analytics function to review and identify appropriate central data sources and work with study teams to define assumptions for data curation and insight development
- Articulate the data story to teams based on based on country-level feasibility and centrally derived data to support data-driven decisions to enhance protocol design
- Project management of study level country landscape assessment activities and the collection of targeted feasibility information to support an early assessment of operational feasibility for conducting clinical trials.
- Lead study level engagements to obtain, analyze and deliver high quality targeted information from external stakeholders to inform study design and operational planning decisions.
- Lead study level activities to generate and deliver patient level insights as required to teams to inform study design and operational planning.
- Prove input into a range of continuous improvement activities to ensure consistency of Global Trial Optimization process execution.
- In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors utilized in Global Trial Optimization processes
- Partner with study teams to develop and implement patient recruitment and retention tactics aligned with defined study strategy.
- Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
Experience And Required Skills :
- Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval
- Compelling communicator with the ability to translate complex messages to a variety of audiences.
- Proven ability to build strong working relationships in a diverse range of team environments
- Experience in utilizing data to inform clinical strategy development
- Ability to understand complex business questions and develop effective solutions
- Experience in process development, implementation and change management activities
- Thrives in a highly dynamic environment where creativity is key in meeting the needs of key stakeholders
- Self - motivated, good interpersonal and leadership skills, a team player
- Line management experience preferred
- At least 10 years of relevant industry experience within pharma/biotech, a CRO or consulting is required, with 2 years of functional leadership highly desirable.
Education:
- Qualified candidate will have a BS in a related discipline; A MS or MBA is highly desirable
Company Description:Our Client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, their unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in their own laboratories. Their medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.