Director, Clinical Science

Responsibilities:
- Support the clinical lead or serve as clinical lead for early phase program(s)
- Independently lead clinical execution of one or more studies; may be accountable for program level clinical deliverables
- Lead development of protocols and associated amendments to ensure quality and operational delivery; partner with/support Clinical Lead in governance review and approvals
- Lead development, review, or approval of key documents (Informed Consent Documents, Investigator Brochure, Investigator Letters, and safety documents)
- Lead development of recommendations on strategies for internal committees
- Provide scientific/medical guidance to study teams, including CRO teams
- Review safety data, serious adverse events (SAE) reports; author/review/update safety and regulatory documents as required; track SAE and present data during Safety Review Team meetings
- Collaborate with research and translational scientists to provide clinical input supporting pre-clinical compound development
- Lead development and review of publication content/quality and provide input to publication strategy
- Examine and interpret clinical data at study and program level; author or review Clinical Study Reports (including narratives)
- Attend site initiation visits (in person or by TC) to present study design and protocol key aspects
- Lead compilation and analysis of data for/from dose critical issue and/or safety review committees, in collaboration with the program physician
- Develop, build, and maintain investigator and site relationships to support site selection and study start-up
- Represent the project internally and support drug development externally as a medical scientific expert; support alliance development as appropriate

Qualifications:
- Ph.D., PharmD, or Master’s degree in a relevant clinical or biomedical field
- 8+ years of clinical drug development or medical research experience in pharmaceutical/biotech or academic environments
- Oncology or immunology experience

Skills/Experience (required/preferred):
- Advanced understanding of clinical practice across tumor types and how it is evolving with new therapies; understanding of cancer cell biology
- Experience leading delivery and influencing at senior leadership levels (internally and externally)
- Experience working/leading in matrix teams
- Strong collaborative communication skills; ability to lead through conflict with a diverse client base
- Proven problem-solving and solution-focused issue management
- Experience collaborating externally with clear requirements for collaborative contracts and scientific engagement
- Effective communication, presentation, and organizational skills to ensure coordinated, timely delivery
- Demonstrated scientific writing skills
- Experience adopting AI and evolving technologies to improve efficiency and quality of clinical practice
- Proven team leadership experience (2–3 years) in a clinical setting
- Ability to work proactively and independently; strong organizational skills
- Ability to support and mentor junior team members