Clinical Development Scientist, Director

Job Responsibilities
- Leadership:
- Autonomously and independently lead clinical execution of one or more studies (medium–high complexity; significant business impact); may be accountable for program-level clinical deliverables.
- Contribute to continuous improvement/process enhancement and innovative approaches to maximize clinical trial execution effectiveness.
- May provide matrix management support to one or more clinical colleagues.
- Content Creation:
- Provide clinical input to the development of the protocol design document (PDD).
- Lead protocol development from the approved PDD to maximize operational efficiency, trial quality, and participant/site engagement; minimize likelihood of amendments or quality issues; partner/support Global Development Lead in governance review/approval.
- Lead development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Author and manage approval of Informed Consent Documents (ICDs), including responses to external stakeholder questions.
- Clinical & Safety Oversight:
- Provide clinical input to development of data collection tools.
- Provide clinical input to SAP, tables/listings/figures (TLFs), and blinded data review (BDR).
- Establish Data Monitoring Committees (DMCs) and endpoint adjudication committees (chartering, contracts, provision of relevant data/documentation of outcomes).
- Provide clinical input to the Integrated Quality Management Plan (IQMP); review and approve final.
- Input to/review/approve Risk Management and Safety Review Plan; ensure activities align and support implementation of risk mitigations.
- Review/approve country selection; develop site selection criteria; contribute to site training materials.
- Serve as primary contact for external investigators and internal teams on protocol clinical questions.
- Review, report, and manage protocol deviations.
- Review patient-level and cumulative data per data review plan across one or more studies.
- Review safety data, SAE reports, TMEs, DMEs; ensure clinical documents (e.g., ICD) are updated as required.
- Track/reconcile SAEs; lead presentation during Safety Review Team meetings.
- Ensure trial master file (TMF) compliance for clinical documents.
- Clinical Reporting:
- May contribute to clinical sections of regulatory filings (e.g., Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, regulatory authority responses).
- May support responses to regulatory queries and Clinical Trial Applications (CTAs).
- Input to/review Clinical Study Report (including narratives); support disclosure of safety/efficacy and trial conclusions; contribute to primary publication of results.
- Provide clinical support to audits/inspections.

Basic Qualifications
- Advanced degree or professional certification in a health care related, scientific, or technical discipline.
- Biopharmaceutical clinical research & development experience:
- BA/BS: 8+ years
- MBA/MS: 7+ years
- PhD/PharmD: 5+ years
- Clinical research experience in phase 3/pivotal space.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical, administrative, and project management capabilities; excellent English verbal/written communication with internal and external stakeholders.
- Demonstrated experience establishing, managing, and training clinical development teams.

Preferred Qualifications
- Oncology experience highly preferred.
- Passion for helping patients.
- Proven analytical skills with ability to work on large data sets.
- Effective communication, presentation, and organizational skills.
- Demonstrated scientific writing skills.
- Global perspective; effective in diverse teams and with internal/external partners and investigators/medical professionals.
- Solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance).
- Proficient with basic IT; uses computer and telecommunications (voice/video) effectively.
- Flexibility to adapt to changing environments while maintaining integrity/quality.
- Competencies: problem-solving and agile decision-making; leverage others’ support/knowledge; adopt evolving technologies/best practices; promote team health; foresight/judgment, communication, partnership building, collaborative conflict resolution; promotes innovation and appropriate risk-taking; proactive independent work and organization of tasks/time/priorities.

Application instructions
- None provided.