Medical and Regulatory Affairs - Clinical Trial Lead

Clinical Trial Lead, Immunology & Neurosciences

At Client, we are inspired by a single vision transforming patients' lives through science. In oncology, hematology, immunology, neurosciences, and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary:

Clinical Trial Lead, Immunology & Neurosciences will be a Clinical Scientist on assigned Medical Affairs Sponsored Trial (MAST), responsible for contributing to and ensuring quality execution of deliverables for all phases of assigned MAST. Responsible for driving the development, tracking and maintenance of the Integrated Evidence Plans for the assigned Immunology & Neuroscience assets. Provide the day-to-day oversight and conduct of the Investigator Sponsored Research (ISR) Book of Work for Immunology & Neurosciences asset.

Key Responsibilities:

• Ensure high quality and timely execution of key deliverables (e.g. protocols and data read outs), maintain data integrity, and implementation of quality assurance plans for assigned MAST
• Accountable for ensuring scientific integrity and data quality is maintained during executions of assigned MAST
• Lead the development, tracking and maintenance of the Integrated Evidence Plans (IEP) and facilitate the cross-functional alignment for assets in Immunology & Neurosciences, in the form of slide decks and/or tech enablement platform
• Develop IEP(s) that reflects asset strategy, market priorities and medical evidence generation support (investigator vs company sponsored research) in partnership with the Immunology and Neuroscience Global Medical Disease Team and cross-functional teams including (but not limited to) Global Drug Development (GDD), Translational Development, Health Economics and Outcomes Research (HEOR), and others
• Develop Areas of Interest (AOI) based on key open data questions (ODQ) identified in the IEP with market input in collaboration with the Immunology and Fibrosis Global Medical Disease Team
• Assess and identify any disease area gaps not addressed by the IEP(s)
• Responsible for ongoing Immunology and Neuroscience ISR work, including non-clinical research studies and serve as the subject matter expert and interface with all key stakeholders across the matrix, including (but not limited) to Worldwide and Local Medical, Global Development Operations (GDO), GDD, Field Medical, Commercial, and HEOR
• Conduct regular book of work reviews in partnership with GDO with key medical and development stakeholders, under their remit
• Interface with Market contacts (Field Medical and/or Medical Affairs) on the conduct of ongoing ISRs, as well as new concepts/protocols and those in development
• Partner with Business Insights and Analytics for acquiring metrics on ongoing studies and the development of visualization tools to analyze the performance of the ongoing book of work
• Identify studies at risk for failing to meet timelines and negotiate mitigation plans with key internal stakeholders and investigators
• Accountable for ISR data reporting and major congresses to inform medical capabilities and other internal stakeholders
• Assist in the reviews of concepts through RFP process, as appropriate, including providing context for ongoing book of work, area of interest development, and upcoming data read-outs
• Chair concept reviews, as delegated

Qualifications & Experience:

PharmD, PhD or MD

2+ years of experience as Clinical Scientist on clinical trials, with demonstrated proficiency in driving and managing company-sponsored clinical trials

2+ years of experience with Investigator Initiated Clinical Trial oversight

Understands GCP/ICH, drug development process, study design, statistics, clinical operations

Demonstrated track record of leadership in a complex, matrix environment

Experience delivering successful results in a variety of business situations

Excellent communication skills and experience with difficult discussions

Successful track record of leading through influence and working across complex, global organizational matrices

Domestic and International travel may be required