Director Clinical Science

Primary Job Function

Clinical Development Leadership

• Serve on the clinical development leadership team and help set strategic direction for global and regional functions.
• Govern critical issues and non-conformances arising from clinical studies and escalate them when needed.
• Participate in budget planning, workload review, resource planning, and efficiency strategies.
• Participate in strategic and project teams and provide pharmacokinetic expertise to development, regulatory, and product teams.

Subject Matter Expertise

• Provide leadership and guidance to pharmacology and clinical pharmacology teams.
• Guide teams on technical clinical guidelines and relevant guidelines in EPD markets.
• Guide formulation teams on formulation technology and pharmacokinetic impacts.
• Partner with CROs, project management, regulatory affairs, marketing, product development, and medical affairs.
• Review pharmacokinetic sections of regulatory and safety documents when needed.
• Guide due diligence for compounds under investigation for licensing and co-development.

People and Resource Management

• Set team goals aligned with business objectives.
• Manage resources for PK and safety physicians across ongoing studies and forecasting.
• Evaluate team development needs and plan training implementation.
• Share pharmacokinetic expertise and train the team on techniques, tools, formulation development, and current guidelines.

Accountability and Scope

• Allocate clinical pharmacology and bioanalytic teams and budgets to project teams to meet timelines, patient safety, and data quality objectives.
• Align the Clinical Pharmacology and Bioanalytics department with EPD strategy.
• Provide guidance to clinical pharmacology teams so programs run within agreed timelines and budgets.
• Ensure implementation of the Clinical Pharmacology and Bioanalytics strategy in regional teams.
• Maintain relationships with external experts, CROs, and regional EPD groups.

Education and Experience

• MD, PhD, or equivalent education.
• Demonstrated ability to lead and guide teams in a complex, multinational organization.
• Ten to fifteen years of pharmaceutical industry experience.
• Strong understanding of formulation development programs and targeted product profiles.
• Experience with differentiated generics and clinical programs for biosimilars or biologics.
• Understanding of CROs in emerging markets and technology and formulation knowledge.

Core Competencies

• Communication, customer service orientation, decision making, leadership, and strategic innovative thinking.
• Coaching and consulting, cross-team integration, planning and organizing, and stakeholder management.

Location

• The position is located at Abbott's Mumbai Development Center in Mumbai, India.
• Travel is not specified.

Compensation

• The base pay is listed as N/A.