Job Description

Company Description

Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait .


We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.


For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity - to strengthen our core further (the next steps) and to build the future (the new bets).


'The Next and the New' is how we aim to continue to be the partner of choice - purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose - helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency


Dr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Lead - Clinical Sciences


Responsible to support the Clinical Development Strategy, Clinical Development Plan (CDP) and Clinical Trial Outlines (CTO), propose appropriate and efficient pharmacokinetic/pharmacodynamic (PK) design aspects for clinical studies, obtain Target regulatory agency buy-in, support clinical operations and medical sciences teams for seamless execution on clinical strategy; contribute to the analysis of the results including PK/PD and its projection in regulatory documents and publications, perform due-diligence (Medical/ Clinical) for in-licensing deals.

• Based on regulatory needs and business objectives and the Target Product Profile (TPP), prepare/ support preparation of Clinical Development Plan (CDP) and Clinical Trial Outlines (CTOs) for individual clinical trials (including data from literature on comparable clinical trials; product safety data and regulatory data on expectations and requirements to secure approvals)
• Support preparation of Briefing book for target agency submission and obtain target agency buy-in for CDP and CTOs
• Support clinical protocol, CSR and BLA modules preparation
• Ensure adequate provision for data generation during course of studies to arrive at logical data sets facilitating regulatory approvals
• Research regulatory, scientific, clinical practice, stakeholder perspective regularly to stay abreast of trends; identify sources that can be tapped; in case of issues use this data for resolving issues; analyze reports and communicate key points to all relevant stakeholders to enable decisions; attend clinical conferences and participate in seminars as applicable
• Provide inputs to clinical operations & medical sciences team and partners on aspects such as- analysis accuracy and completeness of data as per plan; review trial data reports vis-a-vis design; Interpret and own (eventually drive) root cause analysis in situations of indeterminate outcomes during clinical study
• Work with medical sciences on the contents of publication, presentation and strategic elements of positioning the data; review the analyzed data going to the regulatory team and further to publication in order to leverage data and reduce the differences that a regulator may observe
• Propose appropriate and efficient pharmacokinetic designs for clinical studies, including determining efficient sampling schedules
• Draft and review of Pharmacokinetic sections for Clinical Trial Outlines and Protocols, Collaborates in the preparation of the Pharmacodynamic Sections of CTO and protocols
• Collaborate with the clinical team and other organizational functions on the aspects related to PK and PD of case report form design, query design, inclusion/exclusion criteria, data cleaning definitions, and protocol deviation resolutions,
• Integrate the pharmacokinetic results and collaborate in integrating the pharmacodynamics results in Regulatory Documents.
• Review PK and immunogenicity data for impact assessment perspective.



Qualifications Educational qualification : M.D. or Ph.D. with a specialization in Clinical Pharmacology, Oncology, Rheumatology, or Immunology, and good knowledge in other two areas



Minimum work experience : 15+ years of experience in clinical drug development



Skills & attributes:



Technical Skills

• Demonstrate expertise in Biologics strategy and Biosimilar drug development, understanding unique challenges in this field.
• Broad knowledge of drug development processes from discovery to commercialization.
• Expertise in Oncology and Immunology, emphasizing translational aspects in connecting laboratory research to clinical applications.
• Proficiency in statistical analysis, pharmacokinetics, pharmacodynamics and immunogenicity aspects for insightful data interpretation.
• Regulatory knowledge, including awareness of regional nuances in drug development, and stay updated on scientific, regulatory, and clinical practice trends.




Behavioral skills • Ability to effectively convey ideas, information, and decisions to individuals and groups, coupled with the skill to influence others positively to achieve common objectives.
• Ability to nurture positive relationships, dedication to continuous learning, and the capacity to coach and mentor others, fostering a culture of growth and development within the team.
• Aptitude for creative thinking and problem-solving, coupled with a proactive approach to innovation, enabling the identification and implementation of novel solutions to challenges.
• Flexibility and openness to change, with the capacity to adjust to new circumstances and effectively navigate through evolving situations to achieve desired results.
• Ability to work in ambiguity
• Strong Strategic and Execution blend
• Ability to align cross functional teams for successful execution of trials
• Self-initiative and resilience
• Excellent verbal and written communication skills
• Excellent Planning, influencing and negotiation skills
• Risk taking abilities



Additional Information About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon.

With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales - future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.

With a Product Development engine that has end-to-end capabilities - in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.

Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.

We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure

Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.



Benefits Offered

At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.



Our Work Culture

Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website at https://careers.drreddys.com/#!/