Shire Jobs

Job title : Clinical Research Lead

About the job

Our Team:

Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities:

The Clinical Research Lead (CRL) will oversee and manage clinical research activities within the organization. This role involves designing, implementing, and monitoring clinical trials to ensure they meet regulatory requirements and organizational goals. The ideal candidate will have a robust background in clinical research, strong leadership skills, and a commitment to advancing medical knowledge and patient care.

• Responsible for various strategic activities including Clinical Development Plan (CDP), clinical sections of Integrated Development Plan (IDP), contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions), contribution to IB preparation, contribution to DSUR, DRMP

• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/ communications for the study team and other stakeholders.

• Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, and study teams.

• Accountable for the medical review of data done by the clinical trial team, the case-by-case review of safety events reported to GPE and coding of events and drugs.

• Responsible and contributor to Centralized Monitoring activities: AEDR review, Patient data validation, Clinical Case review, Data review and Data surveillance, protocol deviations review, Key risk indicators (KRI) review, Data Quality assessment (DQA)

• Support recruitment and retention

• The CRL is responsible for the medical content of the protocol, protocol creation and leading any protocol amendment in collaboration with the core study team and responsible for development and amendments of Informed consent document

• Prepares/reviews clinical documents such as: meeting requests and briefing packages for Regulatory agencies, Investigator Brochure, Clinical Study Report, Lay Summary of Results, publications, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD)

• Contribute, review and provide clinical input across different study documents like written subject information, CRF, e-diary, Centralized Monitoring Plan, Monitoring Plan, Statistical Analysis Plan, Data Validation Plan review and validation, predefined Protocol Deviations

• Contributor to different study processes depending on study organization: code-breaking process, IVRS set-up, central reading (if applicable), input on lab tests and other study procedures, CAP approval process, data base lock activities

• Preparation of medical presentations and participation in Investigators’ meetings

• Set-up Adjudication & Steering Committees, Data Monitoring Committee, if applicable

• Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:

• Feasibility managers for feasibility preparation and validation of feasibility results

• Medical Writers: Patients narrative KOM meeting

• Medical affairs team, and Coding team

• Pharmacovigilance (GSO)

• Biostatisticians

• CSU Medical Advisors for the best knowledge of the study, compound, protocol

• TA Experts, senior Clinical Research Directors, global clinical lead, GPHs and Medical Affairs team

• CROs

• Regulatory Affairs

• Manage clinical scientists in the team, as needed

About you

List here ideally the must-haves criteria to be successful on the role. Don’t forget: the less criteria you will request, the more diverse candidates you will get in the pool.

• Experience :

• Robust Scientific and medical/clinical expertise

• Expertise in clinical development and methodology of clinical studies

• Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage

• Experience in writing scientific publications, presenting study findings at conferences, and engaging with the scientific community is valuable

• Experience in protocol development, in designing clinical trial protocols, determining study endpoints, and ensuring that protocols adhere to regulatory and ethical standards.

• Proficiency in interpreting clinical trial data and drawing meaningful conclusions, ability to analyse safety and efficacy data, identify trends, and make data-driven decisions.

• Proficient understanding of good clinical practice guidelines, regulatory requirements governing clinical trials and ethical considerations in clinical research

• Soft skills :

• Train and communicate in an effective way with the people involved in the trial.

• Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders

• Good networking ability in cross-cultural environment

• Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization

• Performance oriented with ability to work along agreed timelines and a focus on strategy and execution

• Problem-solving, conflict-resolution and decision-making skills

• Very good teaching skills, demonstrated ability to assist and train others

• Ability to work within a matrix model

• International/ intercultural working skill

• Open-minded to apply new digital solutions

• Technical skills :

• Demonstrates and maintains deep scientific, technical and clinical knowledge in either Pulmonary, allergy, or immunology, or demonstrate strong experience in drug development

• Understands and keeps up to date with the pre-clinical, translational and clinical data relevant to the molecule of interest and the respective therapeutic area

• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products

• Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders

• Demonstrated capability to challenge decision and status quo with a risk-management approach

• Ability to negotiate to ensure operational resources are available for continued clinical conduct

• Education : Medical Doctor (MD)

• Languages : Fluent in English (verbal and written)

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)