Scientific Associate Director – Project Toxicologist

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary scientific liaison between Translational Safety & Risk Sciences and various project teams from discovery to post-marketing.

• Represent the TSRS Project Team and lead the TSRS sub-team on essential project teams.

• Create and execute tailored nonclinical safety strategies that align with regulatory requirements.

• Modify safety strategies based on new data and the needs of the project team.

• Collaborate with teams focused on biotherapeutics, small molecules, targeted protein degraders, RNA-based therapies, and other intricate modalities.

• Oversee the TSRS sub-team and utilize the TSRS advisory network to guide human risk assessments and development strategies.

• Design, execute, manage, and analyze nonclinical safety assessment programs.

• Innovate study designs by incorporating AI-enabled methods and New Approach Methodologies to improve translational risk assessment.

• Assess experimental data and draft sections of nonclinical strategy, governance, and regulatory submissions, including first-in-human applications and marketing authorizations.

• Facilitate communication with TSRS, project teams, leadership, governance bodies, and regulatory agencies.

• Manage multiple project teams and stakeholders within a dynamic, highly matrixed environment.

• Work in concert with internal scientists and external collaborators.

• Contribute to licensing evaluations, due diligence reviews, and external partnerships.

• Mentor and guide fellow scientists in nonclinical studies and development initiatives.

⛳️ Requirements

• Doctorate degree (PhD, PharmD, or MD) with 4 years of experience in Toxicology, or a Master’s degree with 7 years of Toxicology experience, or a Bachelor’s degree with 9 years of Toxicology experience.

• At least 8 years of experience in drug development as a Project Toxicologist/Nonclinical Safety Project Team Representative at all stages of development, including late-stage assets and interactions with global regulatory bodies.

• Comprehensive experience in safety assessment for both small and large molecules across various therapeutic areas and modalities.

• Preferred background in nonclinical safety assessment of siRNA therapeutics, antibody-drug conjugates, antibody-peptide conjugates, and/or targeted protein degraders.

• Demonstrated capability to function as a cross-functional thought leader and foster alignment across R&D departments.

• Subject matter expertise in a specified area of toxicology.

• Experience in supporting business development initiatives through due diligence assessments.

• Proven scientific leadership with experience in matrixed management.

• Strong communication skills with the ability to influence a diverse range of partners.

• Recognized externally as a toxicology expert through presentations, publications, and participation in collaborative external groups.

• Board certification by the American Board of Toxicology is a preferred qualification.

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models, including remote and hybrid work arrangements, when feasible.

• Opportunities for career development.

• Financial planning options to assist in saving for retirement or other objectives.

• Support for work/life balance.