Note: The job is a remote job and is open to candidates in USA. Alector develops therapies that harness the immune system to combat neurodegeneration. The Senior Director, Clinical Development will serve as the senior clinical development physician and clinical lead for AL137 as it enters Phase 1 trials, guiding clinical strategy, protocol execution, data interpretation, cross-functional collaboration, and the use of AI in drug development.
Responsibilities
- Lead the clinical development strategy for AL137! Own the clinical and medical strategy for Phase 1 and help shape the program's path toward later-stage development, integrating emerging clinical, translational, safety, and biomarker data into clear decisions
- Deliver a high-quality Phase 1 program! Provide medical leadership for protocol design and execution, eligibility and safety considerations, dose escalation, clinical data review, and interpretation of emerging results while partnering closely with Clinical Operations and investigators
- Be Alector's clinical voice! Serve as the internal physician expert for AL137 and provide clear clinical perspectives to program teams and senior leadership. Build productive relationships with investigators, external experts, partners, and regulatory authorities as appropriate
- Turn data into decisions! Partner across Biometrics, Translational Medicine, Safety, Regulatory, and other functions to define evidence needed for critical development decisions and communicate the clinical meaning of emerging data
- Integrate innovative technologies, including AI, into clinical development! Identify practical ways to use AI and emerging technologies to accelerate analysis, improve decision-making, streamline clinical-development work, and conserve valuable time and resources
Skills
- Ph.D. in Neuroscience, Neurobiology, or equivalent field required
- 10+ years' experience leading clinical development in the biotechnology or pharmaceutical industry; experience taking programs through early clinical development is essential
- Drug development experience in neurodegenerative disease
- Strong knowledge of clinical trial design, medical monitoring, clinical data interpretation, benefit-risk assessment, and the regulatory requirements supporting clinical drug development
- Experience designing and executing first-in-human and Phase 1 and 2 studies, including dose escalation and interpretation of early safety, pharmacokinetic, pharmacodynamic, and biomarker data
- Experience working with regulators and contributing clinical content to regulatory submissions and interactions
- Demonstrated ability to exercise independent medical judgment and provide clinical leadership within cross-functional development teams; you are comfortable operating as the primary internal clinical expert for a program
- Ability to translate complex scientific and clinical information into clear recommendations and collaborate effectively with scientists, development colleagues, executives, investigators, and external experts
- You are an active user of large language models (LLMs) and have a strong interest in evolving AI technologies and how they can improve the quality, speed, and efficiency of drug development
- Experience working in a small or rapidly evolving biotechnology organization where clinical leaders combine strategic thinking with hands-on execution
- M.D. (preferred)
Benefits
- Flexible hybrid work options
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