Sr. Manager, Clinical Development Scientist (Non-MD)

Role Summary

The Sr. Manager, Clinical Development Scientist is accountable for the scientific integrity of the study and the well-being of 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 clinical and operational excellence. The role is responsible for effective execution of studies, partnering with clinical and medical colleagues, clinical operations, and other functional lines to deliver a quality protocol, clinical trial execution, and interpretation and communication of clinical trial data. Maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical issues through timely clinical data, safety and protocol deviation review. Serves as the primary contact with external investigators and internal study teams for questions relating to clinical aspects of the protocol and partners with the Global Development Lead regarding study disease area strategy.

Responsibilities

• Provides clinical input to support development of the protocol design document (PDD).
• Leads or supports development of the protocol from the approved PDD, ensuring efficient protocols that maximize operational efficiency, trial quality, and participant/site engagement, while minimizing amendments or quality issues. Partners with the Global Development Lead in governance review and approval processes.
• Leads or supports 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 the Integrated Quality Management Plan (IQMP). Reviews and approves the final document.
• Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data, and documentation of outcomes.
• Inputs to, reviews, and approves the Risk Management and Safety Review Plan. Ensures activities are conducted per the plan and coordinates with stakeholders to implement mitigations.
• Reviews and approves country selection, develops site selection criteria, and contributes to site training materials.
• Serves as the primary contact with external investigators and internal study team for clinical protocol questions.
• 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, TMEs, DMEs, and ensures clinical documents (eg ICD) are updated as required. Tracks and reconciles SAEs and leads data presentation during Safety Review Team meetings.
• Ensures TMF compliance for clinical documents.
• Inputs and reviews the Clinical Study Report including narrative review. Supports disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of results.
• Provides clinical support to the study team or clinical program in response to audits/inspections, including support as needed.
• May contribute to clinical sections of regulatory filings (e.g., Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports) and regulatory authority responses if required.
• May support colleagues with responses to regulatory queries and audit/inspection findings and CTAs.
• Contributes to continuous improvement and innovative approaches to maximize effectiveness of clinical trial execution.

Qualifications

• Required: BA/BS or equivalent with 6+ years in biopharmaceutical clinical research and development.
• Preferred: MBA or MS with 5+ years of experience; Advanced Degree with 1+ years of experience.
• Demonstrated clinical, administrative, and project management capabilities, plus excellent verbal and written English communication skills in interactions inside and outside the organization.

Skills

• Clinical development knowledge, global/regional regulation familiarity (ICH/GCP), adverse event management.
• Strong collaboration and leadership capabilities; ability to influence and coach others; capable of overseeing others to achieve outcomes.

Education

• Advanced degree in a relevant field (as applicable per qualifications).

Additional Requirements

• Non-standard Work Schedule, Travel or Environment: 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.