Orion Pharma · 1 week ago
Head of Preclinical Safety and Toxicology, Integrated DMPK & Safety, Research & Development
Boston, MA
Full-time
Hybrid
Director/Executive
15+ years expOrion Pharma is a well-established pharmaceutical company operating in over 35 countries, and they are seeking an experienced scientific leader to head their new Preclinical Safety and Toxicology team. In this senior leadership role, you will provide strategic direction for the Preclinical Safety & Toxicology function, guiding a high-performing team while ensuring robust nonclinical safety strategies that support all stages of drug development.
Pharmaceutical
Responsibilities
Lead and develop a high performing team of toxicologists and a pathologist, cultivating an environment that encourages scientific curiosity, collaboration, and continuous learning
Provide integrated strategic direction for all nonclinical safety activities supporting discovery, preclinical development, and clinical progression
Apply comprehensive knowledge of nonclinical safety disciplines and their integration across the business to support Orion’s competitive differentiation
Anticipate and evaluate nonclinical safety challenges in a fast evolving scientific and regulatory landscape, driving innovative, forward-looking solutions
Partner closely with cross functional and Therapy Area teams to guide and coach colleagues in the development of scientifically sound nonclinical safety strategies
Oversee the design, execution, and critical interpretation of in vitro and in vivo nonclinical safety studies across multiple species
Apply advanced scientific and regulatory writing skills to review and author nonclinical components of regulatory submissions (INDs, CTAs, BLAs, MAAs) and health authority interaction documents. Ensure alignment of toxicology input with clinical and regulatory strategies
Prepare and present nonclinical safety data to project teams, governance groups, external partners, and scientific stakeholders
Influence multiple complex development programs through strong cross functional leadership, sound scientific judgment, and effective communication with discovery, development, and regulatory partners
Collaborate closely with research, clinical development, DMPK, bioanalytics, clinical safety, and regulatory colleagues to ensure holistic, high-quality safety assessments. Serve as a key voice in regulatory agency interactions and internal governance discussions
Maintain an active scientific presence internally and externally by supporting publications, presenting at scientific conferences, and engaging with experts and the broader scientific community
In addition to leading the line function, contribute as an independent scientific expert for selected discovery, development, or in licensing programs as the designated Toxicology representative
Qualification
Required
DVM or PhD in toxicology, pathology, pharmacology, immunology, or another relevant scientific field
Extensive experience (15+ years) in biotech/pharmaceutical settings within preclinical safety evaluation, ideally in oncology and pain, across multiple modalities (e.g., SMEs, bsAbs, ADCs, CARTs)
Demonstrated experience serving as, or managing teams serving as, the Toxicology representative on discovery and development programs
Proven track record in designing and executing nonclinical toxicology strategies and studies to support clinical development and regulatory submissions
Experience in developing and mentoring scientific talent and guiding teams in nonclinical safety strategy
Strong knowledge of FDA, ICH, and GLP requirements related to toxicology and safety pharmacology
Hands‑on experience writing and reviewing nonclinical components of regulatory submissions and interacting with global health authorities
A passion for people leadership, team development, and organisational growth
Excellent written and verbal communication skills, with the ability to deliver clear and concise scientific presentations
Benefits
Competitive compensation
Comprehensive benefits package
Flexible hybrid work
Company
Orion Pharma
Orion Corporation is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.
1001-5000 employees
H1B Sponsorship
Orion Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
BlackRock
2025-09-25Post Ipo Equity
2006-07-03IPO
Recent News
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