Aerial Talent
Sr. Director, Translational Development - Biologics
Aerial Talent, Cambridge, Massachusetts, us, 02140
Overview
Senior Director, Preclinical Development — stealth-mode biotech with an innovative approach to antibody-based therapeutics in the immunology space — seeks a Senior Director or Director of Preclinical Development to lead IND-enabling efforts with a proven track record of advancing antibody-based programs from DC nomination into clinical development. This role will involve managing a small team and overseeing all preclinical activities, including in-house and outsourced PK/PD, GLP Tox, DRF, and ADME. Highlights
Founded and backed by a blue-chip investor Newly created role due to company growth Multiple programs in pipeline Reports to VP, Immunology 2 Direct Reports Key Responsibilities
IND-Enabling Expertise:
Design, execute and lead ADME, PK/PD, DRF, GLP tox studies and provide hands-on expertise and guidance on all aspects of IND-enabling preclinical activities, ensuring studies meet regulatory requirements and scientific rigor. Strategic Leadership:
Develop and implement the preclinical strategy for antibody programs, specifically focusing on bi- or multi-specific antibodies, to support successful IND submissions and progression to clinical trials. Data Analysis & Interpretation:
Critically analyze and interpret complex preclinical data, draw sound conclusions, and effectively communicate findings to internal and external stakeholders. Team Management:
Manage and mentor a team of 1-2 direct reports. CRO Management:
Select, oversee, and manage external CROs for outsourced preclinical studies. Regulatory Submissions:
Contribute to the authorship and review of preclinical sections for regulatory documents, including INDs, IBs, and other regulatory filings. Quality & Compliance:
Ensure all preclinical activities are conducted in accordance with relevant regulatory guidelines (e.g., GLP) and internal SOPs. Communication:
Present preclinical data and strategies clearly and concisely to diverse audiences, including senior management, scientific advisory boards, and regulatory agencies. Hands-on Lab Work:
Participate in laboratory work, including conducting and overseeing in vivo studies and other relevant preclinical experiments as needed. Minimum Qualifications
Ph.D. in Pharmacology, Toxicology, Immunology, Biochemistry, or a related discipline. 8+ years of experience in preclinical drug development. 5+ years in a leadership role. Extensive experience in leading IND-enabling studies, including PK/PD, ADME, DRF, and GLP Tox for antibody-based therapeutics. Extensive hands-on experience designing, executing, and interpreting IND-enabling studies (in vitro and in vivo), including direct experience with in vivo model work. Proven track record of contributing to IND submissions for antibody-based therapeutics preferred. Experience managing scientific staff. Demonstrated ability to manage multiple projects simultaneously. Extensive experience in managing and overseeing external CROs. This Company is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
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Senior Director, Preclinical Development — stealth-mode biotech with an innovative approach to antibody-based therapeutics in the immunology space — seeks a Senior Director or Director of Preclinical Development to lead IND-enabling efforts with a proven track record of advancing antibody-based programs from DC nomination into clinical development. This role will involve managing a small team and overseeing all preclinical activities, including in-house and outsourced PK/PD, GLP Tox, DRF, and ADME. Highlights
Founded and backed by a blue-chip investor Newly created role due to company growth Multiple programs in pipeline Reports to VP, Immunology 2 Direct Reports Key Responsibilities
IND-Enabling Expertise:
Design, execute and lead ADME, PK/PD, DRF, GLP tox studies and provide hands-on expertise and guidance on all aspects of IND-enabling preclinical activities, ensuring studies meet regulatory requirements and scientific rigor. Strategic Leadership:
Develop and implement the preclinical strategy for antibody programs, specifically focusing on bi- or multi-specific antibodies, to support successful IND submissions and progression to clinical trials. Data Analysis & Interpretation:
Critically analyze and interpret complex preclinical data, draw sound conclusions, and effectively communicate findings to internal and external stakeholders. Team Management:
Manage and mentor a team of 1-2 direct reports. CRO Management:
Select, oversee, and manage external CROs for outsourced preclinical studies. Regulatory Submissions:
Contribute to the authorship and review of preclinical sections for regulatory documents, including INDs, IBs, and other regulatory filings. Quality & Compliance:
Ensure all preclinical activities are conducted in accordance with relevant regulatory guidelines (e.g., GLP) and internal SOPs. Communication:
Present preclinical data and strategies clearly and concisely to diverse audiences, including senior management, scientific advisory boards, and regulatory agencies. Hands-on Lab Work:
Participate in laboratory work, including conducting and overseeing in vivo studies and other relevant preclinical experiments as needed. Minimum Qualifications
Ph.D. in Pharmacology, Toxicology, Immunology, Biochemistry, or a related discipline. 8+ years of experience in preclinical drug development. 5+ years in a leadership role. Extensive experience in leading IND-enabling studies, including PK/PD, ADME, DRF, and GLP Tox for antibody-based therapeutics. Extensive hands-on experience designing, executing, and interpreting IND-enabling studies (in vitro and in vivo), including direct experience with in vivo model work. Proven track record of contributing to IND submissions for antibody-based therapeutics preferred. Experience managing scientific staff. Demonstrated ability to manage multiple projects simultaneously. Extensive experience in managing and overseeing external CROs. This Company is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
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