Director Clinical Science

Abbott Laboratories; Mumbai; On-site; INR 3,000,000 - 5,500,000; Full time

Job summary

Abbott Laboratories in Mumbai, India seeks a Clinical Sciences Director to head the Clinical Sciences Team, providing strategic, scientific and managerial leadership for Clinical Pharmacology and Bioanalytics. This senior role participates in global and regional development and interfaces with regulatory authorities to ensure high-quality deliverables.

The role requires an MD/PhD or equivalent with 10–15 years in pharma, strong leadership, and expertise across clinical development, pharmacology,

Qualifications

• MD/PhD or equivalent required.
• Demonstrated ability to lead and guide teams in multi-country complex organization.
• Strong understanding of pharmaceutical development programs and regulatory guidelines.

Responsibilities

• Head and lead Clinical Pharmacology & Bioanalytics team within Clinical Sciences.
• Set strategic direction for global and regional clinical development aligned with EPD goals.
• Governance of critical issues and non-conformances across clinical studies.
• Lead budget planning and resource allocation for the department.
• Provide pharmacokinetic expertise to project teams and RA as needed.
• Liaise with CRO, PM, Marketing, and Medical Affairs to ensure product success.

Skills

Leadership

Strategic thinking

Communication

Decision making

Coaching & Consulting

Education

MD/PhD or equivalent

Job description

JOB DESCRIPTION:

Primary Job Function: The Clinical Sciences Director heads the department, and provides strategic, scientific and managerial leadership to the Clinical Sciences Team. Ensure that all clinical development work assigned to the Function ie Clinical Pharmacology and Bioanalytics department is carried out in a timely manner with the required quality standards. Ensures scientific excellence and compliance with ethical and regulatory standards of all deliverables of the team ie Clinical Pharmacology and Bioanalytics (internal and external reports, publications, abstracts, posters, communication with Regulatory Authorities etc.) as a member of the Senior leadership of Clinical Development. Stimulate innovative thinking and encourage work/thinking (including publications) that may support the EPD goals. The Director Clinical Science as a core member of Clinical development leadership Team sets strategic direction for Global and regional clinical development functions aligned with EPD Business objectives. Participate in Strategic Teams and Project Team as applicable and provide pharmacokinetic expertise to the Project Teams, Product development team, Label Teams and Regulatory Affairs (RA) if needed.

Core Job Responsibilities:

Clinical Development Strategic and Leadership Activities Serves as a core member of Clinical development leadership Team and helps in setting strategic direction for Global and regional clinical development functions aligned with EPD Business objectives. Responsible for governance of all critical issues and non-conformances arising from clinical studies across various forums and if needed raise to I and D LT. Responsible with other members for planning of departmental Budgets and oversight. Responsible with other members for review of workload and planning of resources for department and strategies for efficiency aligned with EPD objectives. Core member of clinical development leadership team to review TM for clinical development teams. Head and Subject Matter expert for team: Provides leadership and guidance to all pharmacology team in Clinical Development, Provide Guidance to Clinical pharmacology team on various technical clinical guidelines by keeping abreast of all relevant guidelines in EPD markets. Provide Guidance to Clinical pharmacology team, Formulation team for TPP by keeping abreast on various formulation technology and implications, impacts on pharmacokinetic impact. Ensures through discussions, challenging the team for out of box thinking and reviews that Clinical Pharmacology and Bioanalytics is aligned with the EPD objectives Supports the team if needed by Liaising with the CRO and EPD Project Management, RA, Marketing, product development, Medical Affairs to ensure effective partnership for product success Reviews pharmacokinetic clinical part of regulatory and safety documents for established products if needed in absence of TA director. . Guides team for due diligence activities for compounds under investigation for future licensing and co-development if needed. May perform other duties as assigned or requested, including acting as Global Clinical Director for various projects/brands.

Minimum Education:

MD/ PhD or equivalent

Minimum Experience/Training Required:

Demonstrated ability to lead and guide teams in multi country complex organization. 10-15 years of experience in pharmaceutical industry with strong understanding of formulation development programs and guidance of targeted product profile, differentiated generics industry and biosimilar/biologic experience on clinical programs. Understanding and knowledge of various CROs in EM. Understanding of technology and formulation knowledge

Core Competencies:

Communication, Customer Service Orientation, Decision Making, Leadership, Strategic innovative Thinking

Functional competencies:

Coaching and Consulting, Cross-Team Integration, Planning & Organizing, Stakeholder management

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Product Development

DIVISION: EPD Established Pharma

LOCATION:

India > Mumbai : Mumbai Development Center - EPD

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us:

• Facebook
• LinkedIn
• YouTube
• Twitter