Senior Principal Scientist Pharmacology Full-time

Senior Principal Scientist Pharmacology

3Rs Portfolio Innovation and External Engagement

Location: Beerse, Belgium or Spring House, US.

Role Summary: The Sr. Principal Scientist & SIS Scientific Lead is a senior scientific role within Scientific & In Vivo Strategies (SIS), responsible for driving the identification and enablement of 3Rs innovation opportunities into the discovery and preclinical portfolio, including new approach methodologies (NAMs).

Primary Responsibilities:

NAMs Scientific Engagement and Portfolio Integration:

• Engage with fellow SIS Scientific Leads and stakeholders to identify and evaluate ex vivo, in vitro, and in silico (in partnership with data science colleagues) NAM opportunities relevant to discovery and development programs
• Provide subject-matter expert-level guidance on applicability, strengths, limitations and readiness of NAMs within specific disease, modality and contexts of use
• Drive relevant incorporation of NAMs into program strategies, ensuring alignment with portfolio goals, scientific rigor and the broader enterprise 3Rs innovation framework

External NAMs Landscape and Regulatory Awareness:

• Maintain active awareness of the external NAMs landscape, including academic advances, emerging platforms and biotech innovations
• Evaluate external NAM developments in the context of scientific maturity, translational relevance, and evolving global regulatory perspectives (e.g., FDA, EMA, ICH, etc.)
• Translate external and regulatory signals into clear, balanced scientific insights to inform on current NAMs integration opportunities as well as to anticipate future state

Internal Capability Enablement:

• Liaison with fellow SIS Scientific Leads as well as internal functional and therapeutic area teams to assess existing NAM capabilities and gaps, relative to portfolio needs and regulatory expectations
• Inform prioritization of NAM development/evaluation and validation efforts based on scientific value-add, feasibility and anticipated regulatory acceptance
• Support development of internal guidance to enable confident and consistent application of NAMs

Scientific Collaboration and Communication:

• Serve as a scientific thought partner to drive project teams to consider 3Rs innovation/NAM-enabled approaches
• Contribute to internal scientific reviews, forums and working groups focused on 3Rs/NAMs innovation
• Support external scientific publications, presentations and internal communications that strengthen credibility and understanding of NAM-based strategies

Domestic and international travel may be required; up to 10%.

May perform other duties and matrix manage team members as assigned.

Education-Minimum Qualification:

• Ph.D. in bioengineering, biomedical engineering, pharmacology, toxicology, systems biology or a related discipline with a concentration in Oncology
• 5+ years postdoctoral experience, preferably in a pharma or biotech setting, focused on NAMs-related platform development (i.e., CIVM/MPS, etc.) within oncology R&D
• Understanding of pharmaceutical R&D governance frameworks
• Excellent communication, facilitation, and leadership skills.

Required Skills:

• Oncology therapeutic area expertise/experience
• Demonstrated expertise integrating models across the NAMs categorical landscape (i.e., combining ex vivo, in vitro/CIVM/MPS, etc.) to enable advanced physio- and pathophysiological relevance at scale
• Demonstrated expertise applying human-relevant models in drug discovery and/or preclinical research contexts
• Track record of scientific innovation or publication in NAMs-relevant field
• Ability to critically assess emerging technologies/platforms within the context of pharma R&D needs and the external global regulatory landscape and clearly communicate implications to stakeholders
• Expertise in basic pharmacology concepts and experience in relevant data analysis best practices and software/tools
• Demonstrated leadership on drafting of scientific publications, internal reports and/or technical presentations
• People and research project management experience
• Proven effectiveness working with cross-functional scientific and data science stakeholders
• Demonstrated experience leading cross-functional initiatives in a matrixed environment.
• Experience interfacing with external technology developers and/or academic collaborators

Preferred Skills:

• Experience managing and implementing organizational change
• General awareness of nonclinical safety and drug development concepts
• Familiarity with global regulatory agency considerations relevant to NAM acceptance

Required Skills: Clinical Data Management, Drug Discovery Development, Innovation, Leadership, Pharmacodynamics, Pharmacology, Pharmacometrics, Pharmacovigilance, Product Lifecycle Management (PLM), Product Management, Research Documents, Risk Management, Scientific Research, Tactical Planning