Chief Scientific Officer
6 days ago
Role Overview
Alera Bio is seeking an accomplished Chief Scientific Officer (CSO) to lead all preclinical, translational, and clinical science strategy for its rare disease therapeutic platform.
The CSO will oversee experimental design, IND-enabling development, and scientific partnerships across Alera's programs. This role is pivotal in translating Alera's mechanistic insights into regulatory-ready data packages and clinical trial readiness. The CSO will play a pivotal role in communicating the platform science and translational impact to potential investors.
Key Responsibilities
Scientific Leadership
- Define and execute Alera's integrated scientific roadmap, spanning formulation design, mechanistic validation, and translational modeling.
- Guide the scientific rationale and preclinical strategy for AB-101 and future pipeline.
- Ensure alignment of experimental approaches with FDA and EMA regulatory expectations for rare and pediatric indications.
- Lead interpretation of pharmacodynamic, toxicology, and pharmacokinetic results to inform dose selection and clinical study design.
R&D and Translational Development
- Direct preclinical study design with CRO partners and academic collaborators, ensuring GLP/GMP readiness and reproducibility.
- Oversee biomarker strategy, analytical method development, and formulation optimization.
- Lead scientific authorship of IND modules, investigator brochures, and regulatory briefing documents.
- Support manufacturing and analytical teams on stability, compatibility, and release specification development.
Strategic and External Partnerships
- Cultivate and manage collaborations with academic investigators, KOLs, and translational research centers.
- Liaise with NIH program officers, foundation partners, and grant reviewers to strengthen Alera's non-dilutive funding strategy (e.g., SBIR/STTR).
- Represent Alera Bio at scientific and investor conferences, communicating the company's platform and translational impact.
Regulatory and Clinical Interface
- Partner with regulatory consultants to ensure robust scientific justification in IND filings and Orphan Drug/Rare Pediatric Disease submissions.
- Support clinical protocol design and endpoint selection for first-in-human studies.
- Guide data interpretation and publication strategy to enhance scientific visibility.
Qualifications
Required
- PhD, MD, or MD/PhD in endocrinology, neuroscience, or pharmacology.
- 15+ years of leadership experience in translational or clinical research, with a record of advancing therapies from concept to IND or clinical stage.
- Expertise in endocrine or metabolic disease biology, small-molecule or hormone analog development, and CNS delivery strategies.
- Demonstrated success in managing multi-site R&D programs and CRO relationships.
- Strong familiarity with rare disease and pediatric drug development frameworks.
Preferred
- Experience leading or contributing to successful IND submissions or orphan drug designations.
- Previous CSO, VP of R&D, or scientific co-founder role in a biotech setting.
- Established network within the NIH, foundation, or rare disease research ecosystem.
- Excellent communication and scientific writing skills for regulatory and investor audiences.
- Previous work in start-up companies
Why Join Alera Bio
- Lead the scientific direction of a first-in-class rare disease therapy addressing a life-threatening unmet medical need.
- Collaborate with a proven biotech founder and executive team experienced in taking programs from seed to IPO.
- Shape the foundational R&D culture of a mission-driven company at the intersection of endocrinology, neuroscience, and precision medicine.
- Help accelerate transformative treatments for patients and families with MCT-8 deficiency and related disorders.
To Apply:
Send a brief statement of interest and relevant portfolio or publication list to
.
Include "Chief Scientific Officer - Alera Bio" in the subject line.
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