Director, Clinical Development Scientist (Non-MD)

Role Summary

The Director, Clinical Development Scientist is accountable for the scientific integrity of the study and the well-being of the patients enrolled in one or more clinical trials. The role applies technical and clinical skills to ensure the design of efficient and high-quality clinical trials, employing quantitative design principles, and clinical best practices to deliver both clinical and operational excellence. Responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. The Clinical Development Scientist is accountable for timely delivery of a quality protocol, clinical execution of one or more large and / or complex clinical trials and supports appropriate interpretation and communication of clinical trial data. Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety and protocol deviation review. Will also be the primary contact with external investigators and the internal study team for questions relating to clinical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy. May also provide matrix management support of one or more IM clinicians on one or more clinical studies or across a clinical program.

Responsibilities

• Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact. May be accountable for program level clinical deliverables.
• Provides clinical input to support development of the protocol design document (PDD).
• Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/supports the Global Development Lead in governance review and approval process.
• Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical input to the development of data collection tools. Responsible for providing clinical input to SAP, TLFs and BDR.
• Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
• Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Inputs to, reviews and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders to develop and implement any risk mitigations.
• Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
• Serves as the primary contact with external investigators and internal study team for questions relating to clinical aspects of protocol.
• Reviews, reports and manages protocol deviations.
• Reviews patient level and cumulative data per the data review plan across one or more studies.
• Reviews safety data, SAE reports, TME‚Äôs, DME‚Äôs and ensures clinical documents (ICD) are updated as required.
• Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
• Ensures TMF compliance for clinical documents.
• Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.
• Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection.
• May contribute to clinical sections of regulatory filings and regulatory authority responses if required; may support development of responses to regulatory queries and audit/inspection findings and CTAs.
• Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
• May provide matrix management support to one or more clinical colleagues.

Qualifications

• Advanced degree or professional certification in a health care related, scientific or technical discipline required
• 5+ years of experience and track record of success in biopharmaceutical industry in clinical research and development
• Clinical research experience in phase 3/pivotal space
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
• Demonstrated clinical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English
• Demonstrated experience establishing, managing, and training teams in clinical development

Skills

• Clinical development and trial design
• Regulatory knowledge (ICH/GCP, AE management)
• Data monitoring and safety oversight
• Protocol development and amendment management
• Stakeholder management and cross-functional collaboration
• Project management and leadership

Education

• Advanced degree or professional certification in a health care related, scientific or technical discipline

Additional Requirements

• Global travel may be required
• This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week