Clinical Development Scientist, Manager

The Clinical Development Scientist (Manager) provides support for scientific oversight data integrity and quality of clinical trials in Internal Medicine with direct responsibility for clinical deliverables for one or more studies.

JOB RESPONSIBILITIES

• Provides clinical support for one or more studies; may provide support for program level clinical deliverables

• Contributes to development of the protocol including protocol amendments Protocol Administrative Change Letters and Dear Investigator Letters

• Supports the study team in internal protocol review governance submissions and interactions

• Contributes to Study Informed Consent Documents and responses to external stakeholder (e.g. Health Authority and Independent Ethics Committee) requests

• May provide clinical input to the development of the Statistical Analysis Plan and Tables Listings and Figures

• Performs clinical data review in accordance with the data review plan and clinical data review best practices; may present data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock

• Reviews safety data and may contribute to clinical document updates in response to emerging safety profile; tracks and reconciles Serious Adverse Events; participates in clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives

• Contributes to clinical activities consistent with the approved Risk Management Plan

• Supports establishment and management of External Data Monitoring Committees and Adjudication Committees including chartering contracting provision and presentation of data and documentation and dissemination of Committee recommendations

• Contributes to site selection criteria provides clinical input to selection of sites and may deliver protocol training to site-facing colleagues

• May participate in investigator meeting; may contribute to ongoing protocol training in response to e.g. protocol amendments emerging data issues and quality events

• Contributes to clinical response development delivery documentation and curation (e.g. in FAQ) for questions relating to clinical aspects of the protocol

• May contribute to protocol deviation sub-category development; ensures protocol deviations identified during clinical data review are reported; contributes to protocol deviation management and reconciliation; may contribute to protocol deviation trends review

• Ensures TMF compliance for clinical documents

• Provides clinical input and review of the Clinical Study Report

• Provides clinical support to disclosure of safety and efficacy data and trial conclusions; may contribute to primary publications

• Provides clinical support to audits and inspections including responding to and addressing audit and inspection findings

• Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution

BASIC QUALIFICATIONS

• Science degree (PhD PharmD or equivalent) with some or MA/MS with at least 2 years or BA/BS with at least 4 years of Clinical Research experience in a similar role in industry

• Clinical research experience preferably in Phase 3/pivotal trial space on the side of the sponsor preferably with experience in study design start-up conduct and close-out including regulatory submissions and inspections

PREFERRED QUALIFICATIONS

• Cardiometabolic disease experience e.g. obesity diabetes endocrinology etc.

• Scientific productivity via publications posters abstracts and/or presentations

• Knowledge of clinical development global and regional regulation and ICH/GCP

• Clinical and administrative capabilities; effective verbal and written communication skills

• Able to set priorities to deliver milestones according to budgets and priorities

• Able to resolve conflicts equitably; fosters open dialogue; addresses conflicts; reads situations quickly; negotiates agreements; escalates issues when appropriate; takes responsibility for decisions

• Shares wins and success; defines success in terms of the whole team; develops strong team morale and spirit; creates a sense of belonging

• Takes personal responsibility for delivery of results

• Able to demonstrate perspective and poise in uncertainty and organizational change

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Global travel may be required

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.