Lead Clinical Operation

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.

Job Summary
We are seeking a dynamic and experienced Leader in Global Clinical Management  for driving  global clinical  operations, biopharmaceutics,  biostatistics, and data management. Have to facilitates program management, commercial initiatives, bio-innovation, and external collaborations, ensuring high-quality  clinical data to enable successful product registration within the regulatory frameworks of India and internationally.

Roles & Responsibilities

• You will be responsible for designing and implementing a robust clinical operation strategy and review study protocols across various business regions to facilitate product approval. Providing guidance and oversight to the team, ensuring comprehensive clinical strategies and seamless collaboration with product vertical leaders.
• You will be responsible to Lead clinical operations of study/ sponsor oversight of CRO by team including site selection, initiation, monitoring and close out as well as review of visit reports.
• You will be responsible to Supervise end to end patient study activities, clinical operations, resolve complex issues to ensure generation of quality clinical data for product approval as per the stipulated timelines.
• You will be responsible to review and ensure development/ vendor oversight of study documents e.g. IB, Protocol, CRF, ICD, patient diary etc., as applicable and study plans e.g. project management plan, clinical monitoring plan, medical monitoring plan, safety management plan, IMP management plan, risk management plan, data management plan, statistical analytical plan etc., as applicable.
• You will be responsible to provide accurate cost & timelines for the provided clinical development strategy and guide team for country where the provided Clinical Development Program can be implemented effectively. 
• You will be responsible to identify, develop, leverage and manage global network of Clinical Research Organisation with the objective of delivering strategic bio studies and high bio success to have better control on cost and timelines for bio studies.
• You will be responsible to provide guidance to data management team on data management
• plans, quality output and robust bio-statistics framework with inputs on SAP (statistical assessment plan).
• You will be responsible for developing the next level of leaders by enabling opportunities for development. You will be actively participating in performance management, recruitment, development, and succession planning activities for Clinical Management function to ensure clinical excellence within the organisation.  
• You will be responsible for capability building to interface with internal and external centres of excellence in areas of bio studies, including academic institutions, subject matter experts and key opinion leaders.
• You will be responsible to ensure compliance to GCP, SOPs, scientific principles and applicable regulations.

Educational qualification: MD/Ph.D (Medicine/Pharmacology), M Pharm

Minimum work Experience: Minimum 15 years of experience in clinical development for New drug products and  Complex Generics.

Skills & attributes:
Technical Skills

• Experience in Preclinical and Clinical Research 
• Experience in working with Contract Research Organisations
• Knowledge in Regulatory Guidelines and Legislations 
• Knowledge on Quality guidelines International Council for Harmonisation (ICH),Good Clinical Practice (GCP) and Safety and Ethics Guidelines

Behavioral Skills  

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Good Negotiation and Influencing skills
• Ability to work collaboratively with Regulatory and cross-functional teams.

People management skills

About the Department
Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

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/#!/