Novartis Hiring for Senior Clinical Research Medical Advisor at Mumbai, Maharashtra Full Time

300+ associates. Join a team of globally collaborative colleagues at the ‘Global Clinical Supply (GCS)’ function to support clinical trials from Phase 1 to approval and be a key interface between Technical Research & Development teams and the Clinical teams!

At GCS, we aspire to become an intelligent, agile organization to deliver more products to more patients efficiently, through empowered and highly capable teams. As a Clinical Trial Supply Manager, you would be a trusted business partner designing & delivering clinical supplies to serve our patients with excellence.

Your responsibilities:Your responsibilities include, but are not limited to:

• Accountable for CRMAs to deliver high quality clinical/Medical program and trial feasibility for GDD and NIBR PoC trials; drives local/regional clinical/medical feasibility process and outcome improvement. Is accountable for adherence to safety standards, regulatory and current legislation. Manages country/cluster/region interface with Global Development and optimizing all in-country clinical trials and drives their ultimate success.
• Leading the country/Cluster/region initiatives for local CRMAs, GDO and Medical Affairs to drives recruitment for GDD/NIBR studies. Represents the medical and scientific interests in internal and external forums to support GDD and NIBR programs. Engages medical experts and investigators in clinical studies, get insights about local patient journey, local standard of care and management or treatment guideline for early identification of potential delays and plan recruitment mitigation plan.
• Is accountable to implement global clinical standards for CRMAs and drives effective implementation of Clinical development objectives in countries. In collaboration with the Trial Monitoring key stakeholders, assists in the development of local study execution plans and timeline commitments. Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time Allocation, initiation and conduct of trials.
• Leads study feasibility and country/region patient commitments. Drives site selection in collaboration with TMO. Review and try to resolve local medical issues / questions and, if feasible, support TMO with recruitment/ operational issues that arise during the entire course of the study – if necessary support the discussion of issues to global teams.
• Perform local AE review for development compounds and provide general medical support for safety issues that provide medical expertise support to pharmacovigilance activities; responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed; follow-up with the Investigator for additional information or clarifications as needed; When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc
• May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as representative in Regional/Global team. Identify high quality local/regional datasets (e.g. registries etc) which could be used to drive innovative study designs or support recruitment
• Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and local regulations. Participation in Early product planning process to ensure that TMO trials conducted optimize cross-functional CO strategy. Participate in global working groups in order to support and improve processes for the CRMA Line function

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

What you’ll bring to the role:

• Medical degree (MBBS; MD) highly desirable. Subspecialty training desirable, but not required.
• At least 7-10 Years clinical development experience in pharmaceutical industry including leadership experience of at least 2 years
• Sound understanding of the overall clinical development and ICH/GCP
• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex clinical / medical / operational issues
• Agility to move fast across different therapeutic areas and indications

Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse,

equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we

collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never

trying!

Imagine what you could do here at Novartis!

Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networ

Division

Global Drug Development

Business Unit

CRMA GDD

Country

India

Work Location

Mumbai

Company/Legal Entity

Nov Hltcr Shared Services Ind

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No