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Lead - Clinical Operations
Job Location: Mumbai
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
We are seeking for candidates who can define the clinical operations, trials and data generation strategies in the Roche to ensure proper execution. To also ensure the product launch in a timely manner having maximum patient impact and maintaining global and country specific compliances. You will be responsible for addressing scientific data gaps by conducting study and research.
The Opportunity:
You will be responsible to develop the data generation strategy for clinical trials along with Director-Medical, post-trial access and compassionate use to deliver effective and actionable information to internal and external partners through data and outcomes analysis to aid the drug launch
You will oversee development of protocols and execution of trials, review its critical milestones (trial specific and compliance), provide insights and guidance to escalated issues from team members to manage the trial process while maintaining established guidelines, policies and procedures
You will generate relevant data by planning and monitoring clinical trials (either in Roche or with Doctors) to identify the patient insights, meet the knowledge gaps in local database and regulatory commitments
You will engage with stakeholders (doctors and hospital management etc.) whenever required to discuss trial regulations and ensure regulatory norms; Engage with Government and Industry bodies to provide inputs on trial regulation policies; Engage with Roche senior management at global level to advocate inclusion of the country in trials
You will guide, mentor and inspire functional team members to emerge as leaders by engaging in thought leadership, assisting in problem solving, facilitating decision making, questioning their assumptions, and help them introspect their ideas to deliver on Roche’s 7 leadership commitments
You will participate in selection process to identify the right talent within the function; determine individual training needs and development plans to build expertise and enhance domain knowledge in the team; create conducive working environment to help individuals perform to the best of their capability; establish individual performance expectations; conduct monthly review individual performance of the team
Who you are
You are a Graduate in Life Sciences. PhD or post graduate degree in medical science with a 15-20 years of experience in medical and clinical operations and knowledge of clinical pharmacology.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.