Head - Medical Sciences

Job 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. Purpose To: Provide medical guidance and inputs and ensure product as well as subject/patient safety interests for all Biologics products throughout the various stages - both during development and post development. Thus encompassing the complete clinical trial lifecycle such as therapeutic area expertise and strategic inputs towards study designs and subsequent data interpretation, marketing approval planning and strategies, medico regulatory interface and interactions, medical operations/medical monitoring, post marketing studies, partner interactions across geographies, market launches; manage vendors for all outsourcing activities; represent as a spokesperson for DRL Biologics for all medical and pharmacovigilance/safety aspects; provide guidance to all team members Within: Clinical council strategy and regulatory guidelines With the objective of : Actively assisting in the clinical development strategy and programs of DRL Biologics by providing medical and technical inputs that will enable ensuring compliance to regulations, product and patient/subject safety, successful peri and post approval engagements towards product approvals and launches Roles and Responsibilities: 1. Planning, Budgeting and Reviews - Medical Sciences Develop long term/ short term implementation plans for Medical Sciences functions in line with CD and program strategy (for both out-sourced and In-sourced clinical trials); cascade plans to team members, allocate work and resources for implementation; evaluate performance of team and project plans in periodic functional reviews; provide status updates during the council review; monitor timely achievement of key deliverables in line with desired quality, budget and timelines; resolve issues and escalations for smooth execution; Assist the CD head in developing new strategy (business driven/ science driven) for clinical trials by providing medical and technical inputs; Provide medical inputs to portfolio, business development to aid decisions in product selection, due-diligence for in-licencing of products. 1. Achieve long term and short CD goals, 2. Build capability to support Global Clinical trials 3, Achieve Business development objectives 2. Clinical Strategy Provide medical and clinical expertise in priority therapeutic/ disease areas (Oncology /Immunology/ Dermatology, any other as per business requirements) and work with Clinical Sciences function to build and propagate scientific strategy. Understand patient needs based on local medical practices. Vet the clinical strategy and protocol from the medical operations and Therapeutics point of view; Review the strategy to provide medical/ technical inputs on feasibility/ viability, challenges (from medical practice practice perspective) and develop mitigation strategies; Plan data reviews and interpretation. Engage and partner with a broad range of healthcare stakeholders- both internal and external and work towards enabling stakeholders on gaining deeper insights on concepts of Bio-similarity. IN ORDER TO ensure robustness of overall Clinical Program Startegy, appropriateness of clinical trial design for smooth execution of clinical trials and generation of adequate and good quality data for approval by Regulatory agencies. 3. Medical Operations Ensure and enable scientifically sound protocol development in line with medical practices and applicable regulatory as well as ethical considerations. Anchor and ensure proper set up and conduct of all trial related medical connect/ meetings such as IM, DSMB, NDAC/ SEC, Therapeutic Area Advisory (TAA) and Ad board meetings. Partner and co-own clinical trials strategies, medical oversight/ medical monitoring, and liaising with TAEs and clinical investigators for both out-sourced and in-sourced clinical trials. Drive timely resolution/ remedial action to avoid impact on deliverables/ functioning of CROs. Ensure complete medical oversight for out-sourced and in-sourced clinical trials. Engage with CROs medical counterpart/ investigators to set expectations for ensuring proper medical decision, protocol compliance, issue resolution during the trials; participate in all the review meetings/ investigator meetings to provide advice from medical stand-point; medical review for the significant safety incidents reported during the trials and analyse cause; communicate with relevant stakeholders to build confidence; troubleshoot from a medical stand-point; act as DRL Biologics representative for any safety/ medical discussion during the trial (questions raised by investigators/ ethics committee); Report safety issues to the regulatory and answer queries generated from the regulatory during the trial. IN ORDER TO ensure clinical trial execution in line with the regulatory, ethical and safety guidelines. 4. Drug safety Work with PV team to ensure timely SAE and AE reporting in compliance with Regulatory guidelines, individual case safety reports (ICSRs), INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports (PSURs/DSURs), RMPs. Ensure continued risk benefit assessment of all Biologics products. IN ORDER TO ensure safety of Biologics products throughout the life cycle of the product, and maintain compliances per applicable regional /global standards. 5. Medical Writing Build capability and execute MW activities for CD such as clinical study protocols, ICFS, clinical study reports, investigators brochure, abstracts, manuscripts CTD modules for BLA/ MAA filings etc. 6. Biostatistics Provide Medical inputs to Biostatistician for preparing the clinical study protocols, data analysis and review of TFLs for clinical study reports. 7. Peri-approval activities and Medical Affairs Lead external interactions with regulators, prescribers, KOLs, partners etc. Participate in peri- approval Regulatory and partner engagements, launch meetings, respond to clinical regulatory queries during product approval and post approval. Review and sign off on medical aspects prescribing information and training materi