Dr. Reddy’s Laboratories Hiring – Life Sciences Candidates Apply online
Dr. Reddy’s Laboratories Hiring – Life Sciences Candidates Apply online. Latest Lead Clinical at Dr. Reddy’s Laboratories for a Master /Bachelor Degree in life sciences. Interested and eligible applicants can check out all of the details on the same below:
Job position: Group Lead Clinical Projects – Biologics Business
Job Location: Hyderabad
Seniority level: Director
Industries: Biotechnology Research and Pharmaceutical Manufacturing
Purpose:
Project/Group Lead is responsible for ensuring conduct of multi-national clinical trials which are complex in nature and in compliance to applicable regulatory framework. Provides strategic direction to project team (consists of internal and external stakeholders) for execution of clinical studies worldwide. Project/Group Lead will also be responsible for direct line-management of Clinical Operations team members and is also responsible to contribute towards functional capability building initiatives
Job Responsibility for Lead Clinical at Dr. Reddy’s Laboratories:
Lead CRO/Vendor Identification, Evaluation and Selection Process
- Identify different CRO/Vendors and roll-out RFI and RFP
- Assess RFI/RFP information and shortlist CRO for further comparisons, discussions with HOD and senior leaders
- Participate in vendor selection visits as Clinical Operations SME
- Facilitate CRO/Vendor finalization
1.Planning and execution of clinical trials –
2. Execute the clinical trials as per Clinical development strategies, review and finalization of various clinical trial documents/plans and Ensure compliance of sponsor oversight plan
- Give strategic inputs and Define various recruitment initiatives
- Provide clin Ops inputs to various study documents and review
- Reviewing KPIs / KRIs, monitoring reports, CRF data, monthly listings/reports,
3. Functional capability building –
- Develop and review various SOPs, Work Instructions, study manuals and share best practices with cross functional teams
4. Ensure overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s)
- Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrollment criteria are met and other aspects of the study management as appropriate.
5. Vendor management and People Management
- CRO/Vendor relations, Collaborate with HOD in manpower planning, recruitment activities and identifying training needs
6. Attend various governance meetings (PTM, CPR, N-CC apex etc.)
- Participate in internal and external governance meetings.
Education Qualifications : Master /Bachelor Degree in life sciences or allied medical fields (e.g., B. Pharm./M. Sc. (Life science)/ M. Pharm./M.B.B.S./Ph.D.)
Experience : Minimum of 12 years of clinical research/ operations experience of which at least 2 years in Biosimilar studies and 2 years of people management
Possible interview questions may be asked for Lead Clinical at Dr. Reddy’s Laboratories
1. Can you provide an overview of your experience in clinical research and how it aligns with the requirements of the Group Lead Clinical position at Dr. Reddy’s?
Answer: Of course. I have [mention number of years] of experience in clinical research, during which I have had the opportunity to work on various aspects of clinical trials, including study design, site management, and data analysis. This experience has equipped me with a comprehensive understanding of clinical research, which I believe aligns well with the responsibilities of the Group Lead Clinical role at Dr. Reddy’s.
2. Clinical trials often involve complex protocols and tight timelines. How do you ensure efficient project management and adherence to timelines in your previous roles?
Answer: Effective project management is essential in clinical research. I prioritize careful planning, clear communication, and continuous monitoring of project milestones. I also believe in proactive issue identification and resolution to prevent delays. In my previous roles, I have successfully managed projects by implementing these strategies, which resulted in projects being completed within or ahead of schedule.
3. Dr. Reddy’s is committed to maintaining the highest ethical and regulatory standards in clinical research. How do you ensure compliance with regulations and ethical guidelines in your work?
Answer: Compliance with regulations and ethical guidelines is non-negotiable in clinical research. I stay up-to-date with the latest regulatory requirements and ethical standards relevant to the regions where trials are conducted. I also ensure that all team members are well-trained and aware of these standards. Regular audits and internal reviews are conducted to confirm compliance.
4. Collaboration is essential in clinical research, involving cross-functional teams. Can you share an example of a challenging project where you successfully collaborated with diverse teams to achieve a common goal?
Answer: Certainly. In a recent project, we faced a challenge related to [mention the challenge]. To address this, I facilitated collaboration between our clinical team, data management, and regulatory affairs departments. We held regular cross-functional meetings, exchanged valuable insights, and collectively developed a solution. This collaborative effort not only resolved the challenge but also improved overall project efficiency.
5. Leadership is a key aspect of the Group Lead Clinical role. Can you describe a situation where you demonstrated effective leadership in a clinical research project?
Answer: Certainly. In a complex clinical trial, I was responsible for leading a team of clinical research associates. During the trial, we encountered unforeseen issues that threatened the project timeline. I took a proactive leadership approach, holding team meetings to brainstorm solutions, reallocating resources as needed, and maintaining clear communication with stakeholders. Through these efforts, we not only resolved the issues but also completed the trial successfully.
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