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Manager/Senior Manager, Toxicology and ADME

New York, NY

About the job


Position: Manager/Senior Manager, Toxicology and ADME


 Company: Gilgamesh Pharmaceuticals


 Location: Remote (USA); preference for the eastern US.

 

Company Background

Gilgamesh Pharmaceuticals is a clinical stage biopharmaceutical company aspiring to deliver innovative therapeutics to address the unprecedented unmet need for improved mental health treatments. Research to date for NMDA receptor antagonist and 5HT2A receptor agonist prototype molecules has revealed exciting efficacy outcomes and shows promise to be a true leap forward in allowing people to achieve more enjoyable, fulfilled lives. Key therapeutic indications under investigation include MDD, Bipolar Disorder, Substance Use Disorder and OCD. All Gilgamesh programs are entirely new proprietary chemical entities. 


 


Manager/Senior Manager, Toxicology and ADME

We are seeking a dynamic and experienced professional to join our team as the Senior Manager/Associate Director of Toxicology and ADME. The successful candidate will play a pivotal role in driving the development of small molecule drugs to support our diverse portfolio of pharmaceutical products. The successful candidate will be responsible for providing committed and accountable leadership to Gilgamesh management by delivering well-developed Toxicology and ADME solutions critical to advancing the company’s development pipeline. This position requires broad-based expertise to help create and implement stage-appropriate solutions for drug development. Specific responsibilities include vendor management and selection, study design, study monitoring of nonclinical toxicology and ADME studies and will work closely with the Head of Toxicology and ADME, Project Management, Clinical Operations, Regulatory, and multiple key stakeholders in internal and external governance committees.



 Key Responsibilities:

1. Leadership and Strategy:

· Provide leadership for nonclinical development that aligns with the overall corporate goals and objectives.

· Provide oversight and direction on nonclinical toxicology and ADME development activities including discovery and later stage development support.

2. Technical Expertise:

· Design, review, evaluate, interpret, report, and compile non-clinical toxicology, ADME, and drug safety data. 

· Oversee, design, and report on nonclinical studies in accordance with international regulatory requirements (FDA, ICH, MHRA, etc.). 

· Manage contract laboratories and ensure delivery of high-quality nonclinical reports that meet regulatory requirements. 

· Author nonclinical sections of applicable nonclinical sections in INDs, IBs, annual reports and NDAs. 

· Present research findings through manuscripts in peer-reviewed journals. 

3. Project Management:

· Develop and manage work plans that include nonclinical development strategies that translate into deliverables and milestones in a constantly evolving work environment.

· Develop contingency plans where necessary.

· Assist in management of the company’s outsourcing activities including selection of outsourcing partners, contract management, budget planning, technical collaboration/supervision and the progression of milestones and deliverables.

· Travel domestically and/or internationally to accomplish objectives, when necessary.

4. Cross-Functional Collaboration:

· Provide project teams with integrated technical, timeline, and budgetary packages to achieve pre-clinical, clinical development and regulatory objectives.

· Communicate risks and delays to line management/project teams in a timely fashion.

· Partner with pharmacology, biology, CMC, and medicinal chemistry to facilitate nonclinical development.

· Travel domestically and/or internationally to accomplish objectives, when necessary, including participation in periodic (~semi-annual) in-person meetings of Gilgamesh employees.

5. Continuous Improvement:

• Drive continuous improvement initiatives to enhance the efficiency and robustness of nonclinical development activities.

• Implement novel technologies and methodologies to stay at the forefront of industry trends.



Requirements:

· MS or PhD (preferred) in pharmacology, toxicology, biology, or a related scientific field is required. 

· Board Certification or eligibility in ATS, DABT, DACVP, or related certification is preferred. 

· Minimum 5 (PhD) to 7 (MS) years of experience in toxicology/ADME in the pharmaceutical/biotech industry is required. 

· Background in pharmacology, toxicology, pathology, DMPK, drug development, and global regulatory requirements is required. 

· Complete understanding of the current scientific advancements in the field. 

· Proficient knowledge of toxicology of small molecules. 

· Solid knowledge of the drug discovery and development processes. 

· Working knowledge of nonclinical regulatory guidelines. 

· Excellent communication and interpersonal skills.

· Ability to effectively collaborate with cross-functional teams and external partners.

· Demonstrated proficiency in multi-tasking and flexible work style in a fluid environment.

· Experience in preparing IND (or IMPD) and/or NDA/MAA submissions.

If you are a highly motivated individual with a passion for improving the lives of patients with neuroscience and mental health disorders, we encourage you to apply for this exciting opportunity. Our company offers a competitive salary, equity, benefits package, and opportunities for professional growth and development.


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