Associate Director, Clinical Scientist, Genetics Medicine

As an Associate Director, Clinical Sciences, leads in the development, evaluation, planning, and execution of clinical studies; ensures scientific integrity and interpretation of study data for a clinical development program. Collaborates in a matrix, cross-functional environment and supports early and/or late phase candidate development.

Typical day may include:
- Serve as lead Clinical Scientist (for program and/or delegate of Therapeutic area lead)
- Contribute to program team meetings; participate in scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent function with other departments
- Maintain deep knowledge of therapeutic area(s), disease biology, clinical manifestations, standard practice, and drug/candidate mechanism of action and landscape
- Propose, design, and execute early and/or late stage clinical research and development studies; develop strategy proposals supported by literature
- Develop Expanded Synopsis; author clinically relevant sections; review protocol/amendment scientific content
- Author/review trial documents (medical monitoring plans, SAPs, informed consents, Clinical Study Report components) and support regulatory document development; perform quality review/approvals; adjudicate and resolve cross-functional comments
- Ensure compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs for clinical safety
- Lead planning for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority) and present data (SIV) to external investigators and internal collaborators
- Perform clinical/medical data review including safety monitoring to ensure patient safety
- Apply analytical skills to understand how objectives/design impact data analysis; identify risks and mitigation strategies
- Promote consistent clinical data review techniques; review clinical data review plan and medical monitoring plan for assigned studies/programs
- Peer coach/mentor junior team members as appropriate

This role may be for you if:
- Can lead in a matrix environment; demonstrates diplomacy and can influence across functions
- Shows initiative, creativity, and innovation; identifies process improvements
- Resolves novel problems with advanced skills and creative application
- Has proven leadership in global clinical trials and clinical program execution
- Has strong cross-functional management, interpersonal, and problem-solving skills
- Has proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP
- Has a track record of clinical trial process improvements; substantial cross-functional experience

Qualifications:
- Bachelor’s degree required
- Advanced degree (PhD/MD/PharmD/MSc) preferred
- ≥ 10 years of pharmaceutical clinical drug development experience (other levels considered based on experience)
- Proficient knowledge of drug development process, Good Clinical Practice, study design, clinical research methodology
- Solid medical writing skills

Benefits (U.S., if applicable): health and wellness programs (medical/dental/vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).

Application instructions:
- Apply now.