Senior Director of Clinical Development
Cambrian Bio is a clinical-stage drug development company focused on building therapeutics to treat and ultimately prevent some of today's most debilitating chronic diseases, including platforms targeting critical metabolic pathways that decline with age such as AMPK, mitochondrial activation, and MTOR.
ATX-304, which the Cambrian team is advancing through clinical trials, is a novel, peripherally restricted, oral small molecule AMP-activated protein kinase (AMPK) and mitochondrial activator in clinical development for obesity.
Position Overview
Cambrian is seeking a Senior Director, Clinical Development to provide clinical and scientific leadership for the ATX-304 program. This role will be responsible for planning and executing assigned clinical studies and will participate in shaping the overall clinical development strategy for the program.
Reporting into senior clinical leadership, the Senior Director will work closely with Clinical Operations, Regulatory Affairs, Biostatistics, CMC, and external partners to ensure high quality execution of clinical studies in alignment with regulatory expectations and program objectives. This role is well suited for a clinically trained leader who can operate strategically while remaining closely engaged in study level execution.
Responsibilities
- Provide clinical leadership across assigned studies, from planning through completion and final clinical study reports.
- Participate in setting and refining the clinical development strategy for ATX-304, ensuring alignment with corporate objectives and regulatory requirements.
- In close partnership with the Head of Clinical Operations, support the execution of clinical studies from study startup through closeout, ensuring compliance with GCP and applicable regulatory guidelines.
- Collaborate with Medical Writing to support the development of key clinical and regulatory documents, including protocols, investigator brochures, and clinical study reports.
- Provide clinical input into study plans, including data management and statistical analysis plans, and support vendor selection and oversight as needed.
- Provide medical oversight for ongoing clinical trials, including medical monitoring and safety assessment activities, to ensure patient safety and trial integrity.
- Review and contribute to safety data reviews, emerging risk assessments, and escalation of safety related issues in collaboration with internal teams and external partners.
- Work closely with Regulatory Affairs, Biostatistics, CMC, and other internal teams to support regulatory interactions, data safety monitoring activities, and engagement with key opinion leaders.
- Represent the program in internal and external scientific, clinical, and regulatory discussions as appropriate.
- Analyze and interpret clinical study data, integrating safety, PK/PD, and emerging efficacy signals.
- Present clinical findings and program updates to internal stakeholders to inform decision-making and next stage development.
- Serve as a scientific/clinical spokesperson for ATX-304, supporting external presentations and communications (e.g., investor updates, scientific conferences, and key scientific meetings) as needed.
- Ensure clinical activities are conducted in accordance with GCP, ICH, and applicable regulatory standards.
- Support preparation of regulatory documentation and contributions to health authority submissions as needed.
Qualifications
- MD required; board certification strongly preferred.
- Minimum of 8+ years of experience, with at least 5+ in clinical development within the biotechnology or pharmaceutical industry.
- Experience across early and later stage clinical development, including studies conducted in both the US and Europe.
- Strong understanding of clinical development processes, regulatory expectations, and GCP.
- Demonstrated ability to operate effectively in a small or emerging biotech environment, working cross functionally and with external partners.
- Demonstrated experience contributing to clinical protocol development and study design, with hands on involvement across multiple phases of development.
- Prior exposure to regulatory interactions, including preparation of briefing materials and participation in meetings with health authorities, preferred.
- Proven ability to influence and collaborate effectively across cross functional teams in a matrixed, fast-paced environment.
- Demonstrated excellent verbal and written communication skills, with the ability to clearly convey complex clinical and scientific information to internal and external stakeholders.
Compensation
Cambrian offers competitive compensation packages that are made up of base salary, bonus, and equity:
- Salary: $225,000-$275,000 offered to NYC employees, commensurate with relevant experience; salary range may vary depending on state of residence
- Bonus: Performance-based bonus opportunity
- Equity: Employee stock options vesting over four years with a one-year cliff
Benefits
In addition to being part of a collaborative and mission-driven team, Cambrian offers a comprehensive benefits package, including:
- 16 company holidays and an unlimited vacation policy
- Comprehensive medical, dental, and vision insurance with fully employer-paid coverage options for employees
- 401(k) with pre-tax and Roth contribution options
- Employee Assistance Program providing free, confidential support through Optum's Life and Work Well
- Flexible Spending Accounts (FSA) and Health Savings Account (HSA)
- Adoption assistance
- Short- and long-term disability coverage
- Basic life and AD&D insurance, with optional voluntary life insurance
Senior Director of Clinical Development
Cambrian Bio is a clinical-stage drug development company focused on building therapeutics to treat and ultimately prevent some of today's most debilitating chronic diseases, including platforms targeting critical metabolic pathways that decline with age such as AMPK, mitochondrial activation, and MTOR.
ATX-304, which the Cambrian team is advancing through clinical trials, is a novel, peripherally restricted, oral small molecule AMP-activated protein kinase (AMPK) and mitochondrial activator in clinical development for obesity.
Position Overview
Cambrian is seeking a Senior Director, Clinical Development to provide clinical and scientific leadership for the ATX-304 program. This role will be responsible for planning and executing assigned clinical studies and will participate in shaping the overall clinical development strategy for the program.
Reporting into senior clinical leadership, the Senior Director will work closely with Clinical Operations, Regulatory Affairs, Biostatistics, CMC, and external partners to ensure high quality execution of clinical studies in alignment with regulatory expectations and program objectives. This role is well suited for a clinically trained leader who can operate strategically while remaining closely engaged in study level execution.
Responsibilities
- Provide clinical leadership across assigned studies, from planning through completion and final clinical study reports.
- Participate in setting and refining the clinical development strategy for ATX-304, ensuring alignment with corporate objectives and regulatory requirements.
- In close partnership with the Head of Clinical Operations, support the execution of clinical studies from study startup through closeout, ensuring compliance with GCP and applicable regulatory guidelines.
- Collaborate with Medical Writing to support the development of key clinical and regulatory documents, including protocols, investigator brochures, and clinical study reports.
- Provide clinical input into study plans, including data management and statistical analysis plans, and support vendor selection and oversight as needed.
- Provide medical oversight for ongoing clinical trials, including medical monitoring and safety assessment activities, to ensure patient safety and trial integrity.
- Review and contribute to safety data reviews, emerging risk assessments, and escalation of safety related issues in collaboration with internal teams and external partners.
- Work closely with Regulatory Affairs, Biostatistics, CMC, and other internal teams to support regulatory interactions, data safety monitoring activities, and engagement with key opinion leaders.
- Represent the program in internal and external scientific, clinical, and regulatory discussions as appropriate.
- Analyze and interpret clinical study data, integrating safety, PK/PD, and emerging efficacy signals.
- Present clinical findings and program updates to internal stakeholders to inform decision-making and next stage development.
- Serve as a scientific/clinical spokesperson for ATX-304, supporting external presentations and communications (e.g., investor updates, scientific conferences, and key scientific meetings) as needed.
- Ensure clinical activities are conducted in accordance with GCP, ICH, and applicable regulatory standards.
- Support preparation of regulatory documentation and contributions to health authority submissions as needed.
Qualifications
- MD required; board certification strongly preferred.
- Minimum of 8+ years of experience, with at least 5+ in clinical development within the biotechnology or pharmaceutical industry.
- Experience across early and later stage clinical development, including studies conducted in both the US and Europe.
- Strong understanding of clinical development processes, regulatory expectations, and GCP.
- Demonstrated ability to operate effectively in a small or emerging biotech environment, working cross functionally and with external partners.
- Demonstrated experience contributing to clinical protocol development and study design, with hands on involvement across multiple phases of development.
- Prior exposure to regulatory interactions, including preparation of briefing materials and participation in meetings with health authorities, preferred.
- Proven ability to influence and collaborate effectively across cross functional teams in a matrixed, fast-paced environment.
- Demonstrated excellent verbal and written communication skills, with the ability to clearly convey complex clinical and scientific information to internal and external stakeholders.
Compensation
Cambrian offers competitive compensation packages that are made up of base salary, bonus, and equity:
- Salary: $225,000-$275,000 offered to NYC employees, commensurate with relevant experience; salary range may vary depending on state of residence
- Bonus: Performance-based bonus opportunity
- Equity: Employee stock options vesting over four years with a one-year cliff
Benefits
In addition to being part of a collaborative and mission-driven team, Cambrian offers a comprehensive benefits package, including:
- 16 company holidays and an unlimited vacation policy
- Comprehensive medical, dental, and vision insurance with fully employer-paid coverage options for employees
- 401(k) with pre-tax and Roth contribution options
- Employee Assistance Program providing free, confidential support through Optum's Life and Work Well
- Flexible Spending Accounts (FSA) and Health Savings Account (HSA)
- Adoption assistance
- Short- and long-term disability coverage
- Basic life and AD&D insurance, with optional voluntary life insurance
