Senior/ Director - Clinical Research Physician (Development)

5+ years

Not Disclosed

Bangalore

10 Oct. 23, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Development Clinical Research Physician (CRP)

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader based in Indianapolis, Indiana, our dedicated employees work to develop life-changing medicines, enhance disease management, and support our communities through philanthropy and volunteerism. We prioritize people and seek individuals who are committed to making a positive impact.

Position Overview

The Development Clinical Research Physician (CRP) plays a crucial role in the late-phase and marketed compounds. Responsibilities include clinical planning, trial execution, scientific data dissemination, regulatory support, and customer engagement. This position collaborates closely with various stakeholders to ensure successful clinical development and commercialization of products.

Key Responsibilities

Clinical Planning
- Collaborate with business units, Discovery, and Clinical Pharmacology to develop and maintain the Draft Launch Label and Value Proposition.
- Contribute to global alignment of clinical strategies and plans.
- Stay updated on pre-clinical and clinical data relevant to assigned molecules.
Clinical Research and Trial Execution
- Plan and review clinical documents, ensuring timely submission.
- Oversee and provide input on Investigator’s Brochures (IBs) and collaborate on local clinical trials.
- Monitor patient safety, track adverse events, and ensure compliance with Good Clinical Practices (GCP).
- Engage with clinical teams for study start-up meetings and provide training to investigators.
Scientific Data Dissemination
- Ensure compliance with local laws and guidelines for data dissemination.
- Support the planning of symposia, advisory boards, and other engagements with healthcare professionals.
- Develop and maintain relationships with external experts and medical communities.
- Assist in the preparation of publications and presentations.
Regulatory Support Activities
- Contribute to label changes and regulatory submissions.
- Provide medical expertise to regulatory scientists and support communication of regulatory issues.
- Participate in risk management planning with affiliates and Global Patient Safety.
Business/Customer Support
- Develop medical strategies to support brand commercialization.
- Address scientific information needs of customers in a timely manner.
- Collaborate with marketing teams and external experts to enhance product value and market presence.
Scientific and Technical Expertise
- Stay informed on medical literature and trends relevant to therapeutic areas.
- Provide scientific training and support to clinical study teams.
- Attend scientific symposia and engage in continuous learning.
General Responsibilities
- Assist management in budget preparation and administration.
- Actively participate in recruitment and retention efforts.
- Foster a positive and productive working environment through coaching and collaboration.

Minimum Qualifications

Education: Medical Doctor (MD) or Doctor of Osteopathy (DO). Must be board eligible or certified in an appropriate specialty/subspecialty.
Experience: Demonstrated knowledge of the drug development process.
Language: Fluent in English, with strong written and verbal communication skills.
Skills: Excellent interpersonal, organizational, teamwork, and negotiation skills.
Travel: Ability to engage in domestic and international travel as needed.

Additional Information

Eli Lilly and Company is committed to providing equal employment opportunities to individuals with disabilities. If you require an accommodation to submit a resume, please complete the accommodation request form here. This form is only for accommodation requests; other inquiries will not receive a response.

Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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Senior/ Director - Clinical Research Physician (Development)

Job Description

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