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Clinical Research Liaison - Investigator Initiated Trials, Oncology
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Through application of scientific training, clinical expertise, and relevant experience, the Clinical Research Scientist (CRS) for Investigator Initiated Trials (IITs) will utilize his/her clinical expertise to help move to decisions more quickly by reviewing submitted concepts and proposals evaluating alignment to the individual molecule IIT program. The CRS will maintain up to date knowledge within the Oncology’s key priorities, including breast cancer, gastrointestinal cancer, and thoracic cancer; particular emphasis will be placed within breast cancer clinical research.
The CRS will be responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective affiliate brand team, Global Brand Development (GBD) team(s), Therapeutic Area Program Phase Medicine, and Translational Medicine team(s) (Early Phase and Exploratory and Program Medicine-EPM). The CRS must be aware of and ensure that all activities are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research
This CRS - IIT will play an integral role in facilitating the US Oncology IIT program within and represent Lilly externally with key thought leaders, institution, networks and collaborative groups. The CRS will be the primary scientific point of contact for the IIT Project Manager and IIT Specialists for scientific and/or clinical issues.
Key objectives of the role will include
Develop and/or help the US tumor leaders in creating and maintaining the IIT clinical scope document, including coordinating with relevant tumor teams and global product teams. He/she will be responsible for maintaining scope documents via semi-annual reviews.
Serve as the Initial point of contact with US Field Medical or clinical investigator for high level review and/or discussion for IIT proposals.
Coordinate with the IIT Project Management Consultant to drive customer service principles throughout the IIT review process, work in coordination to drive success within the IIT review process and study execution.
Collaborate with the IIT Project Management Consultant to ensure leadership is informed of successes and challenges throughout the IIT program.
Evaluate the scientific merit of IIT proposals and triage concepts and proposals based on the alignment to the scope documents for each molecule. Strive for quick responses to investigators for proposals out of scope and direct proposals within scope to the appropriate tumor team and/or GPT team for further review.
Review IIT proposals and publications, as requested by the US tumor leads or Sr Medical Director.
Participate in the Protocol Review Committee (PRC) as a PRC reviewer
Participate, present and lead discussions at IIT review meetings as directed by US tumor team leads or Sr. Medical Director
Maintain regular communication with medical partners to keep the team updated on IIT program changes and status of ongoing trials
Serve as the primary point of contact with US Field Medical and/or investigators to follow up on clarifications or changes requested as part of the review process.
Work closely with the IIT Project Management team to ensure approved protocols have all modifications made prior to contacting.
Meet with key investigators to discuss proposals and protocols, as needed.
Identify and develop relationships with key research networks and/or collaborative groups of strategic importance with a priority to foster IITs with these prioritized networks / collaborative groups.
Identify and lead continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Ensure that any proposed changes align with the MQS Procedure on IITs and the associated Global IIT Review Committee Charter.
Maximize shared learning opportunities across tumor teams and global medical teams capitalizing on best practices
In addition, with direction from the US tumor team lead or US Sr. Medical Director, the CRS – IITs may be asked to participate / assist with any of the following as the business needs arise:
Communicate and collaborate with the Global Product and Brand Teams, The Thoracic Platform Team, Global Health Outcomes (GHO), PRA and TA Program Medicine, Early Phase and EPM / Translational Medicine teams in the development and maintenance of molecule Labels and Value Proposition that address key customer needs (patient, provider, payer).
In collaboration with the commercial integration lead, develop and implement an aligned US medical / marketing launch strategy.
Clinical Research / Trial Execution and Support
Provide affiliate support of Corporate / Global studies conducted in U.S.
Contribute to global alignment of Phase 3b/4 clinical studies planned by U.S., Global or Platform Teams.
Plan, collaborate on and review scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
Support the monitoring of patient safety during study.
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials.
Participate in investigator identification and selection, in conjunction with clinical teams.
Ensure that operational teams have documented the completion of administrative requirements for study initiation and conduct.
Assist in the planning process and participate in study start-up meetings.
Serve as a resource to CDCs / clinical research monitors, investigators and ethical review boards.
Understand and actively address the scientific information needs of all investigators and personnel
Advanced medical related graduate degree preferred, such as: DVM, PharmD, PHD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR
BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.
3+ years Oncology experience required.
3-5 years of clinical experience, or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience.
Breast cancer experience is strongly preferred. Lung / Sarcoma / Gastric cancer experience also a plus.
Knowledge of drug development process preferred
Fluent in English; both written and verbal communications
Interpersonal, organizational and negotiation skills
Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Excellent teamwork skills
Willing to engage in domestic and international travel to the degree appropriate to support the business of the team
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.