WE SPECIALISE IN FINDING FANTASTIC OPPORTUNITIES
FOR DIGITAL AND DATA SPECIALISTS WITH THE MOST INNOVATIVE BUSINESS ACROSS EUROPE AND THE USA.
2 months ago
Principal Duties and Responsibilities
- Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
- In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plan to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization
- Collaborate within Development on the review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
- Identify study issues and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution. Conduct literature reviews as needed for the interpretation of study data and development of next steps.
- Works closely with the medical monitor to assure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
- Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
- Translational medicine: Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support stratification biomarkers.
- In conjunction with the Team Leader/Clinical Leader/CMO, develop presentations and communicates study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Serve as clinical science representative on cross-function teams as assigned
- Candidates must have an advanced clinical or science degree e.g. Pharm.D., PhD in a clinical discipline, M.D.
- 5+ years of clinical research experience in planning, executing, reporting and publishing studies within the pharmaceutical industry. Demonstrated ability to review and summarize study data, including experience in preparing and presenting data. Late stage development/registrational experience is preferred.
- Thorough understanding of the drug development process from pre-IND through registration and post-registration required
- Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
- Fluency in the English language, both written and verbal.
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
- Successful track record for the ability to interpret, analyze, and present clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy.
- Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
- Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audience.
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Strong organization, documentation and communication skills with an ability to multitask.
- Excellent interpersonal skills; ability to collaborate across disciplines.
- Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
- Local to Cambridge MA; ability to travel up to approximately 30% of time.
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.