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.
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- 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.
People Management and Resource Management:
- Sets goals for team aligned with Business objectives
- Responsible for adequate resource management of team of PK and safety physicians for ongoing studies and forecasting.
- Evaluate individual and team development needs and planning for training and implementation of training
- Acquires and shares pharmacokinetic expertise in the team to speed up the learning of new techniques and tools.
- Training of the team for Pharmacokinetics skill and formulation development and impact on PK and latest guidelines to ensure up to date knowledge of team.
Position Accountability/Scope:
- Accountable for the allocation of clinical pharmacology and bioanalytic team (in-house, CRO or external consultant) and of budget to all project teams in the Therapeutic Area in order to meet study timelines, to guarantee patient safety and data quality.
- Accountable for the allocation of clinical pharmacology and bioanalytic team (in-house, CRO or external consultant) and of budget to all project teams in the Therapeutic Area in order to meet program evaluation timelines, to ensure EIB timelines
- Accountable for the overall strategic and clinical alignment of the Clinical Pharmacology and Bioanalytic department with EPD strategy and thinking.
- Accountable for providing clinical pharmacology team guidance and expertise to the Project Teams allowing to effectively run clinical programs (within the agreed time and within budget), use modern communication/management tools and cooperate openly with service providers (CROs, academic institutions).
- Accountable for ensuring the implementation of the Clinical Pharmacology and Bioanalytics strategy in regional teams.
- Accountable for ensuring relationships with key relations such as external experts, CROs, and other regional EPD groups.
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