Digital R&D and Clinical Platforms Lead
Sanofi Group
**Digital R&D and Clinical Platforms Lead - All genders**
+ _Location: Hyderabad India_
+ _Job type:_ **Permanent Full time**
**About the job**
At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.
In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.
Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
**Our Team:**
As the CHC Health and Science Global function within the Digital Division, our mission is clear: we are dedicated to revolutionizing healthcare. We act as strategic partners, providing an organization-wide perspective while effectively utilizing available resources. Our primary focus is on enhancing information systems and refining core competencies in R&D, Regulatory, Sustainability & packaging, Medical, and Development, all to maximize value for our consumers. Our unwavering commitment to consumer-centric transformation is central to our mission, driving us to improve lives and instigate significant change. By seamlessly merging scientific expertise with consumer insights, we're reshaping our approach to research, development, and the delivery of science-driven solutions that positively impact global health. Our dedication to consumer-centric transformation empowers individuals to actively engage in their healthcare journey and fosters a culture of collaboration, co-creation, and the pursuit of ground-breaking scientific achievements through partnerships with consumers
As the leader of Digital R&D and Clinical Platforms Lead, you will have the responsibility of implementing and supporting technology and informatics systems and initiatives that underpin the development, operation, and ongoing enhancement of Laboratory Operations, Clinical, and R&D applications. Your role will involve strategic leadership, managing a skilled team, and collaborating across departments to enhance our regulatory procedures and information management.
In your capacity as the Digital R&D and Clinical Platforms Lead, you will serve as the primary liaison with business stakeholders for CHC R&D applications, aiming to maximize the value derived from R&D & Clinical systems investments and technology partnerships. This role demands a comprehensive understanding of regulatory frameworks and commitments. It is a deeply integrated position, influencing, negotiating, planning, and managing projects to foster alignment and performance across the organization. Enthusiasm, attention to detail, and a dedication to advancing the development of new medicines for patients are essential qualities for success in this role.
**Main responsibilities:**
+ Strategic Technology Liaison: Act as the central link between the Global Science - Research & Development and Clinical functions and technology providers, overseeing the delivery of digital solutions for R&D information. Establish and maintain strategic vendor relationships and governance structures.
+ Digital Strategy: Develop and execute a comprehensive digital strategy for Research & Development and Clinical functions platforms, aligning with organizational goals and regulatory requirements.
+ Technical Solutions Leadership: Lead discussions on technical feasibility, prototype development, and the design of efficient, adaptable, and scalable technology solutions, all in adherence to company policies, regulatory standards, and integration goals.
+ Technology Roadmap Execution: Manage the execution of the approved technology roadmap, ensuring the delivery of development and validation artifacts to meet high-quality standards, compliance, and audit readiness.
+ Team Leadership: Build, mentor, and lead a high-performing team of digital experts (both internal & external) focused on R&D and Clinical domains, fostering innovation and excellence.
+ Vendor Collaboration: Foster strong collaboration with the company's software and support vendors to swiftly address and resolve problems or emergencies, ensuring continuous platform performance.
+ Data Transformation: Leverage Data tools and strategies to transform and enhance R&D and clinical operations, streamlining processes, improving efficiency, and driving innovation in research and development, clinical trials, and consumer innovation practices.
+ Contract and Inventory Management: Establish and maintain an inventory of R&D & Clinical Platform components, including their corresponding contracts and agreements for licensing and support, ensuring comprehensive oversight.
+ Regulatory Compliance: Ensure that relevant digital platforms and processes comply with all relevant regulatory requirements, maintaining the highest standards of quality and safety.
+ Financial Planning and Governance: Contribute to the annual digital investment, budgeting, and planning processes. Manage project budget requirements and actively participate in digital and R&D governance forums.
+ Platform Compliance: Collaborate closely with relevant stakeholders to ensure that solutions, such as Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), Clinical Research Organization (CRO) integration, Clinical Trial Management Systems (CTMS), and Statistical Analysis System (SAS), are developed in accordance with the requirements of 21 CFR Part 11 and systems validation standards, ensuring regulatory compliance and data integrity.
**About you**
**Experience**
+ Bachelor’s degree in a relevant field; Master’s degree preferred. Proven experience (10+ years) implementing and supporting R&D and clinical platforms within Consumer Healthcare, biotechnology and life sciences companies, ensuring efficient operations.
+ Proficient in automating and maintaining scientific capabilities through Electronic Lab Notebooks, enhancing research efficiency and data management.
+ Expertise in utilizing R&D SaaS platforms such as Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF) etc to optimize business workflows and processes in quality-focused manufacturing production environments, improving operational efficiency.
+ Exceptional leadership and team management skills.
+ Excellent communication and stakeholder engagement abilities.
+ Demonstrated ability in evaluating, negotiating, and managing contracts and Statements of Work with R&D technology vendors and implementation/support providers.
+ Possesses comprehensive knowledge of Quality Assurance and regulatory compliance, including 21 CFR Part 11 and FDA regulations, ensuring technology solutions meet industry standards.
+ Proven IT project leadership skills, including the capacity to gather clear business requirements and develop business cases with compelling value propositions, aligning technology initiatives with organizational goals.
**Soft skills:**
+ Strong communication, negotiation, and interpersonal skills
+ Demonstrated conflict resolution & problem-solving skills in a global environment.
+ Strong appetite to learn and discover, entrepreneur mindset.
+ Adaptable and open to change
+ Team player, service-oriented
+ Analytical and synthetic, able to formalize solutions, good writing skills.
+ Strong oral and written communication skills
+ With leadership attitude, autonomy and results driven.
+ Role model our 4 values: teamwork, integrity, respect, courage
**Education:**
+ Bachelor’s degree in a relevant field; Master’s degree preferred. Proven experience (10+ years) in digital leadership roles within the Lifesciences or consumer healthcare industry.
**Languages:**
+ Fluent spoken and written English - French is an asset
**Pursue progress, discover extraordinary**
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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