Dr. Venkatramana Nagire

Engaged as a Medical Affairs Consultant, providing expert guidance and strategic insights to various stakeholders in the healthcare sector. This role involves leveraging extensive medical knowledge to support drug development and market access initiatives. Collaborating with cross-functional teams ensures that medical strategies align with business objectives, enhancing the overall effectiveness of clinical and commercial operations. The focus remains on driving therapeutic innovations and optimizing patient outcomes through scientific excellence.

• Successfully led multiple presentations to regulatory authorities, influencing decisions on New Drug Applications and clinical trials.
• Instrumental in launching several high-impact drugs across different therapeutic areas, including liver transplantation, and dermatology.
• Managed numerous clinical studies as Principal Investigator, contributing to significant advancements in medical knowledge and patient care.
• Implemented new SOPs for grants and sponsorships, streamlining processes, and improving operational efficiency.
• Conducted extensive training programs on pharmacovigilance and good clinical practice, enhancing compliance and safety awareness within the industry.

• Responsible for providing medical and scientific leadership into medical brand(s) team and other brand related functions throughout the compound lifecycle. As GMAD, I support the Global Medical Head in the execution of Medical Affairs activities in alignment with Global Medical Affairs function. Key markets include but not limited to Asia Pacific, Sub-Saharan Africa, Middle-East and Latin America.

Responsible for providing medical and scientific leadership into medical brand teams and other brand related functions from pre-launch through the whole life cycle of the compound.

Major Accountabilities:

1. For the assigned Global Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input

2. Serve as a disease area scientific and medical expert for global internal customers/stakeholders, e.g., GCT, Scientific Review Committee, research, exploratory development, device development, Marketing, Novartis local and regional medical organizations, and other line functions within GMA&HEOR and external customers e.g., External Medical Experts (EMEs) and patient advocacy groups.

3. Build together with the GBMD/Portfolio GBMD a highly influential medical and scientifically based platform

4. Provide strategic medical scientific input for the assigned program/brand(s)

5. Provide medical scientific support to CPOs, Worldwide franchises, and GMA Teams

6. Support or deputize GBMD/Portfolio GBMD in providing input into brand safety related activities for the assigned program 7. Support GBMD, portfolio GBMD, in ensuring compliance of promotional and non-promotional global material, and all Medical Affairs activities.

To direct and lead the professional clinical science base for the disease area(s); to efficiently and effectively deploy resources to support the business; to oversee all strategic and operational activities for responsible Medical Affairs team to maximize appropriate use of Novartis products.

Medical Affairs Strategy and Operations

• Leads effective execution of cross-divisional Global Development strategies and tactics ensuring strategic alignment.

Regulatory and Risk management

• Is accountable for adherence to safety standards, regulatory and current legislation.

Internal /External relationships

• Manages country interface with Global Development, taking accountability for and optimizing all in-country clinical trials and drives their ultimate success.

Talent Development

• Maintains and drives the standards of medical and scientific excellence cross-divisionally through recruitment, training, deployment and development of appropriate associates.

Integrity and Compliance

• Works within Integrity and Compliance policies and ensures those around him/her do the same.

Medical Expert (ME) Management & Medical Support Develop professional relationships; build advocacy and scientific partnerships with MEs/decision makers, through regular field-based interactions.

Clinical Development Support

Contribute to the identification of appropriate clinical investigators and facilitates placement into Novartis sponsored clinical trials.

Information Management/Insights

Collaborate with Novartis colleagues to actively support medical and scientific meetings by collecting and interpreting insights /presentations/ results.

Medical Expert (ME) Management & Medical Support Develop professional relationships; build advocacy and scientific partnerships with MEs/decision makers, through regular field-based interactions.

Clinical Development Support

Contribute to the identification of appropriate clinical investigators and facilitates placement into Novartis sponsored clinical trials.

Information Management/Insights

Collaborate with Novartis colleagues to actively support medical and scientific meetings by collecting and interpreting insights /presentations/ results.

1. Over all responsible for organization and conduct of bioequivalence and pharmacokinetic studies in conformance to GCP standards, SOP’s and applicable regulations

2. To liaise with the Ethics committee for review and getting approval for study protocols and Informed consent documents