Senior Director, Preclinical and Translational Development

Job Description

Job Description

Zag Bios vision is to develop more precise, potent medicines for immune-mediated diseases. Zag Bio is pioneering engineered antibody therapies targeted directly to the thymus, with the goal of generating central tolerance. Our technology platform is inspired by the work of co-founder Diane Mathis of Harvard Medical School; additional co-founders include Alan Crane (Polaris Partners), Jo Viney (Seismic Therapeutic), and John Kulman (Zag Bio). Our first program is in Type 1 Diabetes, and we have raised a Series A financing that enables us to advance into the clinic. Our ultimate ambition is to transform the treatment of a broad range of immune-mediated diseases.

We are seeking an experienced Senior Director of Translational Science to join our dynamic biotech startup in Cambridge, MA. This critical leadership role will drive the translational science strategy and execution from development candidate into the clinic, including oversight and integration of non-clinical pharmacokinetics and pharmacodynamics (PK/PD), bioanalytical sciences (nonclinical and clinical), non-clinical safety assessment, biomarker development, and clinical pharmacology. Reporting to our Chief Operating Officer, as the first Translational Science leader you will play a pivotal role in advancing our innovative therapies to patients, beginning with our lead program in Type I Diabetes.

RESPONSIBILITIES:

• Lead the design and execution of integrated translational strategies that bridge preclinical and early clinical development, ensuring alignment across toxicology, DMPK, mechanistic biomarkers, and pharmacology.
• Ensure implementation of IND-enabling toxicology studies and bioanalytical assays, and quality and compliance at the functional level for IND/CTA and BLA filings for clinical studies.
• Contribute to clinical study design and regulatory materials and interactions.
• Implement biomarker strategies in the clinic, managing relationships with academic partners and CROs.
• Identify art-of-the-possible opportunities to maximize the value and probability of success of the program.
• Stay current with emerging scientific and clinical advantages in immune-mediated diseases, actively identifying and integrating novel technologies and approaches into the translational strategy.
• Proactively identify and manage translational risks.
• Serve as a key translational medicine liaison with cross-functional teams and external partners, communicating translational plans, progress, and data effectively to diverse audiences.
• Provide input to business development activities and decisions from the perspective of clinical pharmacology and translational medicine.

QUALIFICATIONS:

• Advanced degree (PhD, MD, or equivalent), preferably in immunology or related disciplines.
• Extensive experience (10+ years) in translational science within biotech or pharmaceutical settings, with demonstrated leadership in driving translational programs through preclinical and early clinical development, including:
  • Deep understanding of toxicology and DMPK principles as they relate to translational decision making.
  • Experience driving the implementation of mechanistic biomarkers in the clinic.
  • Experience engaging with regulators and driving IND/CTAs.
• Prior experience with translation of antibody biotherapeutics is required.
• Prior experience in immunology / inflammation is required.
• Prior experience with Type 1 Diabetes is highly desirable.
• Prior experience on the operational side for biomarker implementation, including engagement with external vendors and academic partners is desirable
• Prior experience in preparation and review of protocols, study reports, etc. for regulatory submission is desirable
• Prior experience with regulatory T cells (Tregs) in disease contexts is desirable.
• Able to identify academic and industry partnership opportunities to validate antigen selection for indications beyond Type 1 Diabetes
• Able to balance and drive both strategy and execution.
• Excellent communication and collaboration skills, capable of influencing cross-functional teams and external partners.
• Bias to action and capacity to thrive in a fast-paced, entrepreneurial startup environment at our Cambridge, MA location (on-site/hybrid).

Zag Bio values the diversity of our workforce and maintains a deeply respectful, values-driven working environment. We are committed to equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time .