Medical Director Ii

Novartis

2+ years

Not Disclosed

India

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Clinical Research Lead
Location: Hyderabad, India
Company: Novartis
Division: Development
Functional Area: Research & Development
Employment Type: Regular, Full-Time

Job Summary:

The Clinical Research Lead is responsible for overseeing the planning, execution, and interpretation of clinical trials. This role provides clinical leadership and strategic guidance for clinical deliverables in assigned clinical programs, ensuring the efficiency and compliance of all clinical research activities. The individual will serve as a medical expert, driving the development of clinical strategies, protocols, and reports while collaborating with internal and external stakeholders.

Major Accountabilities:

Clinical Leadership & Strategy:
- Provide leadership and strategic guidance for all clinical deliverables in assigned clinical programs.
- Drive the execution of clinical programs in collaboration with global line functions, ensuring alignment with global strategies.
- Lead the development of clinical sections for trial and program-level regulatory documents.
- Contribute to medical input during reviews of Integrated Development Plans (IDP) and Clinical Trial Plans (CTP).
Stakeholder Engagement:
- Act as the medical expert in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, and advisory boards).
- Collaborate with internal stakeholders to ensure alignment with clinical and regulatory goals.
- Contribute to medical/scientific training of relevant Novartis teams.
Operational & Project Management:
- Support clinical research leaders in developing disease-specific clinical standards and contribute to the training and development of high-potential talents.
- Serve on or lead global initiatives such as process improvements, training, and SOP development.
- Ensure the execution of clinical trials according to timelines, quality standards, and regulatory requirements.
Adverse Event Management:
- Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
- Manage the distribution of marketing samples where applicable.

Key Performance Indicators:

Achievement of unit objectives and clinical trial delivery within quality standards and agreed timelines.
Adherence to Novartis policies, guidelines, and external regulations.

Minimum Requirements:

Work Experience:

Strategy Development: Experience in clinical trial strategy and planning.
Project Management: Proven ability to manage and lead clinical trials.
Collaboration: Skilled at working with cross-functional teams across boundaries.
Operations Management: Extensive experience in managing clinical operations and ensuring timely execution.

Skills:

Clinical Trials, Data Monitoring, and Medical Research
Cross-functional Team Collaboration
Drug Development and Discovery
Data Analysis
People Management

Languages:

Proficient in English.

Why Novartis?

Novartis is dedicated to improving and extending the lives of people with diseases. Their work culture fosters collaboration, support, and inspiration, with teams working together to achieve breakthroughs that transform patient outcomes. Novartis seeks passionate individuals who are ready to contribute to a brighter future for healthcare.

Benefits & Rewards:

Novartis offers a range of benefits to support employees’ personal and professional growth. Learn more about benefits in the Novartis Life Handbook.

This position provides an opportunity to make a meaningful impact by leading clinical trials and working with a team of experts in a global organization that values innovation and collaboration.

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Medical Director Ii

Job Description

Job Summary:

Major Accountabilities:

Key Performance Indicators:

Minimum Requirements:

Work Experience:

Skills:

Languages:

Why Novartis?

Benefits & Rewards:

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