Clinical Development Scientist, Senior Manager

Clinical Development Scientist (Senior Manager)

The Clinical Development Scientist (Senior Manager) is responsible for scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies. They may also supervise and mentor others.

Job Responsibilities

Provides clinical support for one or more studies; may be accountable for program level clinical deliverables.

May provide input to the protocol design document; 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; supports the Global Development Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions.

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

Provides clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and Figures.

Provides clinical input to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; performs clinical data review; 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.

Provides clinical input to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and may update clinical documents 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.

Provides clinical input to the development of the Risk Management Plan; conducts clinical activities consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations.

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.

Participates in investigator meeting planning and may develop and deliver protocol training; may develop and deliver ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events.

May serve as a clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; contributes to clinical response development, delivery, documentation, and curation (e.g., in FAQ).

May author protocol deviation sub-categories; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; may lead 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 publications.

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

May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests).

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

May supervise, mentor, or develop others.

Basic Qualifications

Science degree (PhD, PharmD, or equivalent) with at least 1 year, or MA/MS with at least 5 years, or BA/BS with at least 6 years of Clinical Research experience in a similar role in the biopharmaceutical industry.

Preferred Qualifications

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

Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out, including regulatory submissions and inspections.

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.

Track record of achievement in pharmaceutical development; able to execute clinical development during design, start-up, conduct, close-out, and reporting.

Understands the complexities and recent developments in the principal disease areas; competent discussing scientific and regulatory aspects of drug development.

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

Effective leader; able to mentor/coach, delegate to, and oversee others; able to develop others' skills and move them toward autonomy.

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.

Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.