Clinical Strategy Expert

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 an experienced Strategy Expert  to conceptualize plans for complex generic products, including liposomal formulations or depot preparations. Your responsibilities will involve developing integrated strategies that are both cost-effective and timely, ensuring alignment with regulatory requirements and market demands.

Roles & Responsibilities
• You will be assisting  to conceptualize plans for complex generic products, such as liposomal formulations or depot preparations. This entails developing integrated strategies that are both cost-effective and timely.
• Your role involves conducting due diligence on in-licensing dossiers for developed markets and performing medical evaluations of business deals. This ensures that only the best products are selected for in-licensing and business deals.
• You will be responsible for supporting portfolio teams by providing medical evaluations and clinical strategies at pre-Apex and Apex meetings, ensuring that future product selections are grounded in sound medical and clinical reasoning.
• You will be responsible for developing plans to facilitate clinico-regulatory discussions with regulatory agencies, aiming to secure clinical waivers and positive opinions on innovative clinical approaches through scientific advice meetings and controlled correspondence.
• You will lead a team in preparing clinical dossiers for submission to regulatory agencies in developed markets, facilitating quality submissions within specified timelines..
• You will be responsible to oversee statistical resources for developing plans and conducting analyses in clinical studies, ensuring robust statistical methodology and final study outputs.

Education Qualification-MD/DM- Pharmacology
 
Minimum Experience Required- 3-5 years of working experience in the clinical operations department of a Clinical Research Organisation /Sponsor
 
Skills & attributes – 
Technical Skills 
• Understanding of Indian Pharmaceutical Industry
• Experience in clinical projects management, SO & process improvement
• Experience in managing clinical budgets, Statutory & Regulatory Guidelines like Good Clinical Practice (GCP), New Drugs and Clinical Trials Rules, 2019 (NDCT), USFDA, EU
Behavioural Skills
• Excellent communication and interpersonal skills.
• Efficient Leader and a good collaborator.
• Good at building and leveraging relationship.
• Strong analytical and problem-solving abilities.
• Strong decision-making skills.

About the Department
Global Generics India
Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market.

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/#!/