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Director, Nonclinical Due Diligence & External Innovation
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-08-22
Listing for:
CSL Plasma Inc.
Full Time, Part Time
position Listed on 2026-08-22
Job specializations:
-
Research/Development
Regulatory Compliance Specialist
Job Description & How to Apply Below
EMEA, CH, Glattbrugg, CSL Behring:
Americas, US-MA, Waltham, CSL Behring time type:
Full time posted on:
Posted Todayjob requisition :
R-280300
The Director Non-Clinical Due Diligence & External Evaluations provides scientific leadership for nonclinical due diligence supporting CSL’s in‐licensing, acquisitions, and strategic collaborations. The role ensures integrated, objective, and decision‐relevant evaluations of nonclinical pharmacology, PK/QSP, and toxicology data to identify development risks, data gaps, and mitigation strategies and to inform portfolio decisions.
The incumbent will further act as nonclinical representative for selected Research programs and support oversight of nonclinical strategies and programs across all Therapeutic Areas.
The role reports to the Executive Director, Head of Nonclinical Development.
** Responsibilities and accountabilities
*** Leads operational execution of nonclinical due diligence for assigned opportunities.
* Acts as hands‐on scientific integrator, translating expert input into clear risk narratives.
* Trusted subject‐matter lead for nonclinical DD on individual deals.
* Lead end-to-end nonclinical due diligence for individual assets or transactions, from request through final governance readout.
* Integrate input from Toxicology, PK/QSP, Nonclinical Pharmacology, and external experts into a single, coherent scientific assessment.
* Identify FIH‐enabling gaps, translational risks, and regulatory limitations, with clear mitigation proposals.
* Prepare high‐quality DD reports, executive summaries, and risk tables for governance review.
* Act as NCD scientific interface to Business Development and Therapeutic Area teams at the project level.
* Contribute to maintenance and continuous improvement of nonclinical DD frameworks and templates.
* Mentor junior contributors and matrix team members as appropriate.
* Escalates complex or high‐impact issues to Head of NCD
* Chair of “NCD Review Committee”
*
* Qualifications:
***
* Education:
*** Advanced degree (Ph.D., D.V.M., or equivalent) in toxicology, pharmacology, or a related field
* Toxicology training, board certification preferred
** Experience :
*** Experience in nonclinical development (10+ years) with proven experience in due diligence or external innovation, ideally across various geographies.
* Strong understanding of FIH‐enabling nonclinical requirements, particularly for biologics and complex modalities.
* Ability to communicate complex scientific risk clearly to non‐expert stakeholders.
* Experience across multiple therapeutic areas and modalities is highly desirable.
*
* Competencies:
*** Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
* Experience in working in cross-functional, multicultural and international teams.
* Excellent communication and analytical skills.
* Experience in analyzing and presenting research results to scientific and professional audiences.
* Strong planning and organizational skills.
* Ability to work successfully in a matrix organizational structure.
* Strong negotiation skills and ability to identify and engage internal and external expertise as needed.
* Good understanding of drug development process, strong knowledge of ICH/GLP
* Fluent in English, oral and written;
The role requires onsite presence 3 days per week.
The role can be based in Zurich, Switzerland or Waltham, USA.
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