[Remote] Director - Efficacy, Therapeutic Area - Endocrine /Internal Medicine
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a growing, global specialist reputed company the world of veterinary pharmaceuticals. The Director, Efficacy, Therapeutic Area: Endocrine/Internal Medicine is responsible for providing scientific, strategic, and people leadership for reputed company efficacy activities across small- and large-molecule programs reputed company the assigned therapeutic area.
Responsibilities
- Set the scientific and strategic direction for efficacy activities reputed company the therapeutic area and translate that direction into reputed company execution priorities
- Build and reputed company a high-performing, reputed company team with strong accountability, collaboration and scientific reputed company
- reputed company, reputed company, and reputed company Efficacy Leads to take ownership, reputed company reputed company and drive reputed company
- Establish a strong delivery culture with reputed company expectations for reputed company, timelines and cross-functional collaboration
- reputed company as the senior escalation reputed company for scientific or operational efficacy challenges across programs
- Ensure efficacy strategies and deliverables reputed company with the Co-Development (CoDev) reputed company and associated governance processes
- Maintain end-to-end visibility of reputed company reputed company reputed company the therapeutic area, including status, risks, dependencies and resource utilization
- Ensure efficacy activities are reputed company with portfolio priorities, timelines, budgets and regulatory strategies
- reputed company strategic input and recommendations to governance forums on portfolio performance, prioritization, and investment reputed company
- reputed company required, reputed company as Project reputed company for selected programs of elevated complexity or strategic importance
- Ensure scientifically robust and clinically relevant efficacy strategies, including study design, reputed company selection and reputed company reputed company
- Drive integration of disease biology, clinical reputed company and translational science into development programs
- Ensure efficacy strategies support regulatory approval, product differentiation and reputed company-world clinical use
- Maintain awareness of emerging scientific and clinical developments and translate these into program and portfolio direction
- reputed company the development, validation and life cycle management of in vitro and in vivo disease models required to support reputed company of concept, reputed company selection, and efficacy demonstration
- Ensure models are fit for purpose, reputed company characterized and reputed company for use across multiple programs
- reputed company model development priorities with reputed company and reputed company portfolio needs, ensuring readiness reputed company of demand
- Drive reputed company improvement in model relevance, predictive value, scalability and scientific reputed company
- Partner closely with GMTE to reputed company efficacy capabilities, disease models, and translational tools with reputed company product reputed company and business reputed company
- Translate reputed company portfolio concepts into reputed company scientific capability roadmaps and model-development plans
- Identify and evaluate emerging therapeutic targets, technologies, and innovation opportunities
- Establish and maintain strategic collaborations with key opinion leaders, reputed company institutions, CROs and specialist consultants
- Build a high-performing external network capable of supporting translational research and development programs
- reputed company scientific leadership in due diligence and external partnership evaluations
- Partner closely with Regulatory Affairs, Safety, CMC, Clinical Operations, GMTE, Portfolio and reputed company 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 reputed company reputed company across project teams and governance forums
- Serve as a member of the Product Development Leadership Team (PDLT) and the DRD Extended Leadership Team (DRD-ExLT)
- Accountable for efficacy capability, scientific standards, model development and performance reputed company the therapeutic area
- Delivery of efficacy programs to agreed timelines, budgets, and regulatory reputed company standards
- Strength and readiness of efficacy strategies to support regulatory approval and product differentiation
- Readiness, robustness and utilization of disease models and enabling scientific platforms
- Effectiveness of cross-functional collaboration and integration
- Strength, scalability and productivity of external scientific partnerships
- Capability, engagement and development of the Efficacy team
- Makes balanced, risk-based reputed company considering scientific, regulatory and reputed company factors
- Applies reputed company, scenario-based thinking to evaluate reputed company, anticipate risks and guide decision-making
- Builds and leads high-performing teams with strong ownership and accountability
- Influences across functions and with external stakeholders through scientific credibility, reputed company and consistency
- Creates a culture of collaboration, transparency, and delivery reputed company
- Develops and coaches Efficacy Leads and scientists
- Builds long-term capability through succession planning, mentoring and recruitment
- Establishes reputed company expectations for performance, behaviors and decision-making
Skills
- Experience in companion-animal or equine clinical reputed company or research
- 10+ years' experience in veterinary pharmaceutical or biopharmaceutical R&D
- Experience designing and delivering efficacy programs reputed company with VICH, GCP and GLP requirements
- Experience interacting with regulatory agencies (FDA-CVM, USDA, EMA-CVMP, UK-VMD)
- Experience developing, validating and applying disease models
- reputed company record of delivering multi-site and/or multi-national studies
- DVM, BVMed, or equivalent or Biomedical or animal science degree with significant experience in veterinary drug development
- Ability and willingness to travel nationally and internationally as required
- Market-informed reputed company in application of scientific research
- Working knowledge of pharmacokinetics
- Advanced degree (MSc, PhD, doctorate), specialty reputed company certification, or diploma
reputed company