Director - Efficacy, Therapeutic Area - Endocrine /Internal Medicine

Main Responsibilities

• Efficacy Therapeutic Area Leadership
• Set the scientific and strategic direction for efficacy activities within the therapeutic area and translate that direction into clear execution priorities.
• Build and lead a high-performing, engaged team with strong accountability, collaboration and scientific excellence.
• Coach, develop, and empower Efficacy Leads to take ownership, make decisions and drive outcomes.
• Establish a strong delivery culture with clear expectations for quality, timelines and cross-functional collaboration.
• Act as the senior escalation point for scientific or operational efficacy challenges across programs.
• Ensure efficacy strategies and deliverables align with the Co-Development (CoDev) framework and associated governance processes.
• Portfolio and Project Oversight
• Maintain end-to-end visibility of all projects within the therapeutic area, including status, risks, dependencies and resource utilization.
• Ensure efficacy activities are aligned with portfolio priorities, timelines, budgets and regulatory strategies.
• Provide strategic input and recommendations to governance forums on portfolio performance, prioritization, and investment decisions.
• When required, act as Project Lead for selected programs of elevated complexity or strategic importance.
• Scientific and Translational Leadership
• Ensure scientifically robust and clinically relevant efficacy strategies, including study design, endpoint selection and success criteria.
• Drive integration of disease biology, clinical practice and translational science into development programs.
• Ensure efficacy strategies support regulatory approval, product differentiation and real-world clinical use.
• Maintain awareness of emerging scientific and clinical developments and translate these into program and portfolio direction.
• Platform and Model Development
• Lead the development, validation and life cycle management of in vitro and in vivo disease models required to support proof of concept, dose selection, and efficacy demonstration.
• Ensure models are fit for purpose, well characterized and scalable for use across multiple programs.
• Align model development priorities with current and future portfolio needs, ensuring readiness ahead of demand.
• Drive continuous improvement in model relevance, predictive value, scalability and scientific impact.
• Strategic Alignment with GMTE
• Partner closely with GMTE to align efficacy capabilities, disease models, and translational tools with target product profiles and business strategy.
• Translate future portfolio concepts into clear scientific capability roadmaps and model-development plans.
• External Scientific Ecosystem
• Identify and evaluate emerging therapeutic targets, technologies, and innovation opportunities.
• Establish and maintain strategic collaborations with key opinion leaders, academic institutions, CROs and specialist consultants.
• Build a high-performing external network capable of supporting translational research and development programs.
• Provide scientific leadership in due diligence and external partnership evaluations.
• Cross-Functional Leadership
• Partner closely with Regulatory Affairs, Safety, CMC, Clinical Operations, GMTE, Portfolio and Commercial functions to ensure integrated development strategies.
• Ensure efficacy considerations are fully integrated into development planning, decision-making and execution.
• Communicate scientific rationale, risks, trade-offs, and decisions clearly across project teams and governance forums.

Qualifications

• DVM, BVMed, or equivalent or Biomedical or animal science degree with significant experience in veterinary drug development.
• Advanced degree (MSc, PhD, doctorate), specialty board certification, or diploma (desirable).
• Experience in companion-animal or equine clinical practice or research (essential).
• 10+ years’ experience in veterinary pharmaceutical or biopharmaceutical R&D (essential).
• Experience designing and delivering efficacy programs aligned with VICH, GCP and GLP requirements (essential).
• Experience interacting with regulatory agencies (FDA-CVM, USDA, EMA-CVMP, UK-VMD) (essential).
• Experience developing, validating and applying disease models (essential).
• Track record of delivering multi-site and/or multi-national studies (desirable).