Medical Expert

Major accountabilities:

• Provides medical support to Clinical Program Leader (CPL) leading the program. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables.
• May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team.
• May represents CPL at project team meetings (e.g. CTT) and may provide inputs to project strategy
• May represent CPL at Investigator teleconferences including dose escalation meetings and site initiation visits.
• Oversees the clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc.
• Leads the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation
• Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team
• Manages stakeholder engagements internally and externally
• Mentors and coaches junior TCO team members in India
• Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Leads or assists with relevant trainings across TCO India
• Advocate continuous improvement of quality
• Ensure all activities of associates comply with company standards and local regulations

Key performance indicators:

• Management of assigned studies to ensure execution according to timelines, and with high quality, ensuring adherence to international and local regulations.
• Demonstrates excellent scientific writing skills to enable the development of quality trial reporting, and regulatory documents.
• Strong evidence of quality medical review of trial data and quality contributions to clinical sections of e.g. protocols, IBs, DSURs and CSRs
• Contribution towards objectives set for the department.
• Feedback from external and internal stakeholders.
• Clearly demonstrates Novartis Values and Behaviors.

Minimum Requirements:

Education:

• MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required.
• Experience in hematology / oncology preferred

Work Experience:

• At least 5 years of pharmaceutical/biotech industry experience
• At least 2 years of clinical practice experience in the hospital setting.
• Experience with oncology clinical trials
• Experience with early development clinical trials
• Knowledge of Good Clinical Practice (GCP).
• Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
• Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects.
• Strategic thinking: ability to network with and influence key stakeholders, clear and logical presentation of complex strategic issues.
• Clear written and verbal expression of ideas, an active/proactive communicator.
• Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships.
• Used to working independently and in a team, being flexible and adapting in a changing environment.

Skills:

• Clinical Monitoring.
• Clinical Research.
• Clinical Trial Protocol.
• Clinical Trials.
• Decision Making Skills.
• Drug Development.
• Health Sciences.
• Lifesciences.
• Medical Strategy.
• Regulatory Compliance.

Languages :

• English.

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Trial Protocol, Clinical Trials, Decision Making Skills, Drug Development, Health Sciences, Lifesciences, Medical Strategy, Regulatory Compliance