Senior Director, Clinical Development
- Compensation
- $290K–$380K / yr
- Location
- North America, United States
- Work setup
- Remote
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 8+ years
- Category
- Not specified
- Posted
Skills
Must have
- M.D. or Ph.D. in Neuroscience, Neurobiology, or equivalent field required.
- 8+ 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
- Ability to translate complex scientific and clinical information into clear recommendations and collaborate effectively with scientists, development colleagues, executives, investigators, and external
- 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.
Full description
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. By harnessing advancements in genetics, immunology and neuroscience, we are pioneering the development of potential therapies to counteract the devastating progression of neurodegeneration. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history.
As Senior Director, Clinical Development, you will serve as Alector’s senior clinical development physician and a key clinical leader for AL137 as the program enters Phase 1 clinical trials. You will bring your medical judgment, scientific curiosity, and drug development experience to help translate an innovative program into meaningful clinical evidence.
You will provide medical and clinical development leadership across the program, working closely with colleagues in Clinical Operations, Translational Medicine, Regulatory, Safety, Biometrics, and other functions. As the program clinical lead, you will have significant ownership and visibility, helping us make rigorous, patient-centered decisions as AL137 progresses through early clinical development.
This role is designed for a leader and “go-getter” who thrives through influence and hands-on contribution.
Key Goals & Accountabilities
- 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.