Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Associate Director, Clinical Scientist at Calico is responsible for the planning and execution of the translational and clinical development plans and protocols for several projects across therapeutic areas, related to Calico’s mission to improve human healthspan by understanding aging and age-related diseases. The successful candidate will participate in and drive the development of clinical strategies for assigned program(s)/indication(s) and should be able to support novel and innovative clinical plans while ensuring a positive and collaborative team environment.

Responsibilities:

• In coordination with the Head of Clinical Science and/or Medical Director(s), leads or represents the Clinical Science function in cross-functional project and study teams that develop and execute the clinical development plan to translate preclinical mechanistic data to humans for novel aging-related targets
• Authors clinical sections of assigned protocols from Phase 0 through Phase 2, collaborating with other functions required for protocol development, including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Biometrics, Pharmacovigilance, Toxicology, and Medical Writing
• Contributes to the design and execution of experimental medicine studies to demonstrate proof-of-mechanism of novel targets in aging and age-related diseases
• Interfaces with academic investigators to assist in execution of Investigator initiated trials
• Contributes to and/or reviews relevant study documents including Investigational Brochures, Clinical Study Reports, Statistical Analysis Plans, Operations/Technical Manuals, IND/CTAs, case report forms and data tables, listings and figures, CSRs
• Trains CROs and study site personnel on assigned protocols and addresses protocol queries as they arise
• Participates in the assessment of CROs and study vendors

Position Requirements:

•  BS/MS in a relevant scientific discipline with 8+ years or PhD/PharmD with 5+ years of experience in early clinical drug development in the biotech/pharmaceutical industry performing the responsibilities described above
• Experience in early clinical trial methodology (Phase 0, Phase 1, Phase 2) and knowledge of drug development process and clinical deliverables from IND through clinical proof-of-concept
• Excellent understanding of clinically relevant ICH GCP guidance, FDA and EMA regulations
• Ability to perform role responsibilities largely independently
• Proven leadership skills and ability to bring out the best in others on a cross-functional team
• Able to provide effective leadership through influence across organizations on partnered programs
• Detail-oriented mindset with excellent oral and written English communication skills 
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $238,000 - $245,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, academic and industry partners, and vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

Calico is seeking a highly motivated Associate Director/Director to join our Translational Medicine team. The successful candidate will lead our preclinical in vivo physiology efforts across multiple disease areas, including, but not limited to, bone disease, sarcopenia, inflammation, and other age-related disorders. In this role, the successful candidate will lead a team of physiology scientists who support indication prioritization, mechanism-of-action studies, and model development for aging and age-related disorders.

Key Responsibilities:

• Lead preclinical physiology team that develops and executes program-specific and indication-specific in vivo studies
• Mentor scientists and associate scientists to effectively serve as translational physiology representatives on project teams
• Contribute to the development of preclinical strategies to advance aging targets to indication-specific and geroscience clinical studies
• Collaborate closely with cross-functional teams to ensure the timely execution of in vivo studies for efficacy, mechanism of action, and biomarker discovery goals
• Prepare and present research findings to project teams and leadership
• Serve as the subject matter expert for in vivo modeling of age-related diseases and conditions  

Position Requirements:

• PhD or equivalent in Physiology, Immunology, Pharmacology, or a related field, with 10-15 years of relevant research in drug discovery or development
• Extensive and wide breadth of experience in in vivo model development and utilization for target validation and drug development
• Strong analytical and problem-solving skills with the ability to navigate challenges within project timelines and identify the critical path activities for drug development
• Demonstrated success in working within cross-functional teams in a collaborative environment as evidenced by IND submissions, patents, or scientific publications 
• Excellent organizational skills with the ability to work on multiple projects concurrently and maintain detailed documentation
• Thorough knowledge of IACUC guidelines/regulations and experience in writing animal use protocols, experimental study design protocols, and standard operating procedures for preclinical studies
• Excellent communication skills, both verbal and written, with the ability to present research findings clearly at team meetings
• Must be willing to work onsite 5 days a week

The estimated base salary range for this role is $215,000 - $265,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents, in compliance with applicable guidelines and regulations. The successful candidate should be able to effectively collaborate with cross-functional representatives, collaboration partners, external vendors, and stakeholders while maintaining a positive team environment. This role will function as a strong project manager and technical leader with demonstrated scientific and stakeholder-focused leadership skills.

Key Responsibilities:

• Document Leadership and Authoring: 
• Provides medical writing leadership for clinical programs
• Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator’s Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)
• Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissions
• Vendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities
• Process Improvement: 
• Develops medical writing best practices (e.g. standard timelines, clinical document templates, Calico Style Guide)
• Partners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirements

Position Requirements:

• Master’s degree in a life science discipline from an accredited college or university; PharmD or PhD preferred
• Minimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization setting
• Expert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g. ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)
• Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials
• Expert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g. SharePoint) and documents management (e.g. Veeva RIM)
• Experience in resource planning and management experience of contractors
• Excellent organization skills with a passion for delivering quality results
• Detail-oriented mindset with excellent verbal and written communication skills
• Self-motivated and able to work collaboratively
• Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $230,000 - $240,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to deepen our understanding of the biology that controls human aging. Calico aims to use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description: 

We are seeking a highly motivated and creative Scientist/Senior Scientist, Aging Biology to join our Translational Medicine team. This role is pivotal in elucidating the mechanism of action (MOA) of therapeutic targets within our aging biology pipeline. The successful candidate will be responsible for defining the molecular and cellular pathways that are fundamental to the program's biology. This role is critical for translating novel in vivo findings into a deep mechanistic understanding to guide its path toward clinical development. The ideal candidate will bring deep expertise in cell biology, MOA studies, and complex signaling pathways to this challenge.

Responsibilities:

• Independently design and lead experimental strategies to elucidate the molecular and cellular mechanisms of action for aging targets and biomarkers, generating insights that guide program direction
• Conduct in vitro and ex vivo studies to investigate target biology in key aging-related processes, including stem cell function, tissue repair, and signaling or transcriptional regulation
• Compare acute and chronic pathway modulation in tissue injury and aging models to understand how stress responses and repair mechanisms evolve with age
• Investigate the molecular drivers of in vivo phenotypes in preclinical aging models to identify biomarkers and translatable mechanisms relevant to clinical development
• Collaborate with in vivo pharmacology and biomarker teams to select and leverage preclinical models that best probe target biology
• Partner with cross-functional groups (e.g., Biomarkers, Genomics, Protein Sciences) to integrate multi-omic datasets and build a comprehensive mechanistic framework
• Analyze, interpret, and present complex data and strategic recommendations to internal project teams and senior leadership
• Maintain rigorous experimental documentation and contribute to internal reports, publications, and regulatory submissions

Position Requirements:

• Ph.D. in Cell Biology, Molecular Biology, Physiology, or a related field, with 2-5 years (for Scientist level) or 5+ years (for Senior Scientist level) of relevant industry or post-doctoral experience
• Demonstrated expertise in designing and executing complex experiments to elucidate mechanisms of action in age-related disease models
• Strong hands-on experience with a range of cellular and molecular biology techniques (e.g., primary cell culture, flow cytometry, single-cell RNAseq, qPCR, Western blot, ELISA, functional assays)
• Proven ability to think critically and solve complex biological problems
• Strong data analysis skills and proficiency with Prism or similar software
• Exceptional organizational skills and meticulous attention to detail, with a proven ability to manage complex projects
• Strong teamwork and communication skills, with an ability to collaborate effectively in a cross-functional environment
• Flexible, able to respond quickly to shifting priorities and to multitask
• Must be willing to work onsite five days per week

Nice to Have:

• Working knowledge of formulation approaches for various routes of administration, including intravenous (IV), subcutaneous (SC), intraperitoneal (IP), and oral
• Familiarity with in vivo models of metabolic or fibrotic disease
• Expertise in mesenchymal or hematopoietic stem cell biology, fibrosis, or tissue repair
• Experience with R or Python for data integration and visualization
• Background in growth factor signaling, extracellular matrix biology, or proteomics

The estimated base salary range for this role is $156,000 - $191,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Medical Director/Senior Medical Director at Calico will report to the Head of Clinical Sciences and will be responsible for providing strategic input to the translational and clinical development of projects related to Calico’s mission to improve human health span by understanding aging and age-related diseases. This position is focused on neurologic/neuropsychiatric indications.

Position Responsibilities:

• Leads cross-functional teams which develop the strategy to translate preclinical mechanistic data to humans and to develop translational biomarkers for novel targets in neurological/neuropsychiatric indications
• Actively interfaces with research and drug development leaders, at Calico and outside of Calico, to inform disease indication strategies for novel targets
• Utilizes clinical expertise to guide the development and utilization of preclinical models in close collaboration with discovery and biomarker scientists at Calico and Calico’s business partners
• Works closely with other drug developmental functional areas to shape new clinical programs at multiple points in their evolution, with an emphasis on translational/early clinical development (Phase 0 through Phase 2)
• Designs and executes experimental medicine studies to demonstrate proof-of-mechanism of novel targets in neuropsychiatric diseases
• Designs and executes early clinical development plans to demonstrate proof-of-concept in various neuropsychiatric indications
• Provides scientific/medical content and other input as appropriate for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents

Position Requirements:

• Scientifically minded Physician (M.D.) or Physician-Scientist (M.D./Ph.D.)
• At least 5 years of translational, clinical trial, or drug development experience in the biotech/pharmaceutical industry, academia, or equivalent
• Board-certified/eligible in Neurology and/or Pediatric Neurology highly preferred
• Clinical/translational research and/or drug development experience across various neuropsychiatric disease areas
• Medical knowledge in treating patients across various neuropsychiatric or neurological indications
• Working knowledge or direct experience in early clinical trial methodology (Phase 0, Phase 1, Phase 2)
• Proven leadership skills and ability to bring out the best in others on a cross-functional team
• Able to provide effective leadership through influence in a highly matrixed environment, including various drug development functions within Calico and its development partners
• Must possess excellent oral and written English communication skills
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $374,000 - $435,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical development and ensure seamless commercialization. Acting as a key partner to CMC and Quality, this role is responsible for the CMC content of all investigational and marketing applications, ensuring technical consistency and compliance across all stages of the product lifecycle, from early-stage development through commercialization. This role requires a blend of deep scientific fluency, meticulous attention to detail, and the ability to negotiate effectively with global health authorities. The ideal candidate has a deep understanding of the nuanced differences in regulatory pathways for both small molecules and monoclonal antibodies.

Key Responsibilities:

Regulatory Strategy and Agency Interactions

• Design and implement innovative global CMC regulatory strategies to secure approvals and maintain compliance for clinical and commercial products, identifying potential risks and creating robust mitigation plans
• Provide expert guidance on CMC requirements for both Small Molecules (NCEs) and Biologics (mAbs), including comparability protocols and stability requirements
• Act as the primary CMC point of contact for the FDA, EMA, and other global health authorities
• Lead preparations for and represent the company in formal regulatory meetings and in generating responses to Health Authority queries
• Assess the impact of manufacturing changes on global registrations and determine the necessary reporting categories globally
• Define the necessary data packages to support post-approval supplements

Submissions and Document Leadership

• Author or direct the preparation, authoring, and technical review of CMC sections for global filings:

-ND/IMPD: Investigational applications for early-phase trials

-NDA/BLA/MAA: Marketing applications for US, EU, and other major markets

• Manage the lifecycle of the Common Technical Document (CTD) specifically focusing on Module 3 (Quality) and Module 2.3 (Quality Overall Summary)

Cross-Functional Partnership

• Collaborate closely with Process Development, Analytical Development, and Quality Assurance to ensure data integrity and filing readiness
• Provide regulatory risk assessments for various manufacturing scenarios (e.g., changing CDMO sites or scaling up bioreactors)
• Monitor and stay current on the evolving CMC regulations (ICH guidelines, FDA/EMA guidance) and translate complex requirements into actionable internal plans

Position Requirements:

• B.S./M.S. in a scientific discipline (Chemistry, Biology, or Pharmacy); A Ph.D. or PharmD is highly preferred
• 10+ years of experience in the biopharmaceutical industry, with at least 7 years focused specifically on CMC Regulatory Affairs
• Successful track record of contributing to least one major marketing application (NDA or BLA) from initial drafting through approval
• Strong understanding of GMP (Good Manufacturing Practices) and ICH guidelines and deep knowledge of small molecule and mAbs modalities
• Ability to interpret complex technical data (e.g., mass spectrometry, impurity profiles, dissolution data) and effectively present it in a clear, regulatory-compliant narrative
• Deep knowledge of FDA, EMA, ICH regulations, and global regulatory requirements
• Exceptional communication and interpersonal skills, with the ability to effectively interact and influence internally with cross-functional stakeholders and senior leadership and externally with CMOs and regulatory authorities
• Must be willing to work onsite at least four days per week

The estimated base salary range for this role is $275,000 - $280,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

We are seeking a highly skilled in vivo scientist to significantly advance neurodegenerative disease research, with a focus on Parkinson's disease. The individual will be instrumental in designing, executing, and interpreting experiments using rodent models to investigate neurological and aging disorders and evaluate therapeutic interventions. This will enhance the Translational Neuroscience team's in vivo research capacity, establish advanced models for due diligence, and test novel drug mechanisms of action. The scientist will also be crucial in modeling novel aspects of neurodegenerative diseases, incorporating human cohort findings, and setting up mechanistic models to test hypotheses from new target discovery.

Responsibilities:

• Develop and characterize novel in vivo models of neurodegeneration and age-related biology
• Design and execute in vivo functional experiments for target validation and mechanistic biology studies
• Conduct broad animal behavioral assessments to characterize neurological phenotypes
• Analyze, interpret, and communicate data and results effectively to the team
• Document data and protocols in accordance with Calico guidelines, maintaining meticulous records of experiments, data, and findings
• Contribute to experimental design, data interpretation, and presentation of results
• Collaborate effectively across multiple functional teams
• Adhere to all animal welfare regulations and institutional guidelines

Position Requirements:

• Ph.D. in Neuroscience, Biology, Pharmacology, or a related field, with 5+ years relevant postdoctoral or equivalent industrial experience
• In Vivo Expertise:
• Experience in live animal surgeries
• Extensive experience with broad animal behavioral assessment techniques
• Expertise in rodent handling, compound treatments, micro sampling, and CNS tissue harvests
• Experience in longitudinal monitoring of behavior and colony maintenance
• Laboratory Skills:
• Practical experience in cellular assays
• Skilled in cells and tissue immunohistochemistry and microscopy, including basic histological techniques for tissue processing, staining, and image analysis
• Analytical & Communication Skills:
• Excellent communication, interpersonal, and organizational skills
• Ability to work independently and collaboratively within multidisciplinary team
• Meticulous with attention to detail
• Must be willing to work onsite 5 days a week

The estimated base salary range for this role is $166,000 - $191,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.