Principal Clinical Research Scientist, Clinical Development Design Hub - Oncology
Clinical Research Scientists (CRSs) are key scientific contributors within the Design Hub (DH). The DH seeks to deliver a core clinical design capability with tightly integrated cross-functional expertise to provide consistent, high quality designs to asset teams. DH CRSs provide scientific, clinical, and therapeutic expertise and guidance. The DH will provide more cross-therapeutic and cross-functional sharing of knowledge as a key objective.
Through application of scientific training, clinical expertise, and relevant experience, the Design Hub Clinical Research Scientist plays a key role in the development of global clinical trials; Design Hub CRSs may work on trials across early and/or late phases of development and commercialization of the product (Phase I to Phase IV). Design Hub CRS also participates in the review process for protocols and publications and, as needed, works with regulatory and other agencies. At times, Design Hub CRSs will participate in activities led by Asset Team CRPs and CRSs, such as outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for a product; and various medical activities in support of demand realization.
The Clinical Research Scientist must have deep understanding of clinical study design and research. He/She must also be aware of novel design and execution paradigms, and be willing to interact and learn from different teams, including different therapeutic areas.
Core Job Responsibilities
The primary responsibilities of the Oncology Design Hub CRS are generally related to Oncology Phase I to IV compounds.
The core job responsibilities include those listed below as well as all other duties as assigned.
Clinical Planning and Clinical Trial Protocols
- Contribute to and, at times, lead efforts to design/develop clinical study protocols aligned with the product lifecycle plan and clinical strategy to address key customer needs (patient, regulator, prescriber, and/or payer). The DH CRS will collaborate with the Oncology Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and design of these protocols.
- Provide clinical leadership in collaboration with other DH members in appropriate development of standardized/simplified processes, template, and tools.
- Provide clinical leadership and insight into DH activities, bringing systematic consideration of impact to execution speed/efficiency in the design of protocols and clinical trial packages.
- Contribute to and, at times, lead development of optimized design and execution elements in clinical plans that deliver high quality, cost efficient clinical development outcomes and provide expert consultation to Business Unit or Research teams in development of their Clinical Program plans. DH input will emphasize organizational learning, best practice application, and systematic consideration of design options.
- Engage appropriately with the asset teams and some of their external activities in order to have good understanding of their patients, medical and payer communities, and business strategy.
- Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans.
- Closely collaborate with asset teams and execution teams to understand the impact of design on speed to protocol approval and optimizing through standardized approaches. Work over time with other DH members to analyze experience and improve approaches.
Clinical Research/Trial Packages, Execution and Support
- Collaborate with other clinical research staff in the design and conduct of clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions)
- Review and collaborate with CRP on the approval of risk profiles to ensure to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection, in conjunction with Design Hub and asset clinical teams.
- Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Understand and actively address the scientific information needs of asset team personnel.
- Support seamless transition of protocols from design to execution.
Scientific Data Dissemination/Exchange
- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on an international basis.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Participate in data analysis and some development of scientific data dissemination, with the objectives of assessing impact of design elements and supporting the continuous learning loop across Design Hub.
Scientific / Technical Expertise and continued development
- Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.
- Be aware of current trends and projections for clinical research, and practice, and access in the therapeutic area(s) relevant to the product.
- Focus on organizational learning to identify best practices, deliverying these as systemized standard approaches with the ultimate goal to make program and protocol design faster and less expensive. This will require cross-TA sharing within the Design Hub and structured efforts to understand the benefit from our repeated, ongoing experiences.
- Contribute to and, at times, lead drug development shared learning amongst collegues within and outside of the Oncology Design Hub
- Work closely with counterparts in other TAs to continue to evolve Lilly standards, tools, and best practices across development.
- Act as scientific consultant and protocol expert for clinical study team members and others in medical.
- Participate in active coaching by providing timely and and constructive feedback to co-workers and others on the Design Hub team, in the spirit of development and increased team effectiveness and cohesiveness.
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.
- An advanced health/medical/scientific (for example, in Pharmacology, Physiology, Microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist, Nurse practitioner) and one of the following:
- 3 or more years of clinical experience, or
- 3 or more years of pharmaceutical experience
- A BS or Master's degree in a health/medical/scientific field with 7-10 years of pharmaceutical experience that is directly related to at least one of the following:
- Clinical trial experience
- Experience in areas relevant to drug discovery
- Drug/clinical development (epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
Primary internal interactions
- Director(s)- Clinical Development and Site Engagement, managers or project managers
- Clinical planning, operations, CRPs/Ss, other research staff
- Scientific communication associates
- Health outcomes research consultants/research scientists
- Regulatory directors, scientists, and associates
- Product directors, managers, and associates of the brand teams
- Legal counsel
- Therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Director-Medicals
- Global Marketing director or manager
- Corporate patient safety physician
- Scientific and clinical experts, thought leaders
- Lilly clinical investigators
- Practicing physicians/prescribers
- Regulatory agency personnel
- 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.
- Professional work experience in clinical development strongly preferred.
- Expertise in one or more areas relevant to clinical trial design are preferred (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, etc)
- Clinical research experience within Oncology is preferred.
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Interpersonal, teamwork, organizational and negotiation skills
- Excellent teamwork skills
- Fluent in English; both written and verbal communications
- Willing to relocate to Indianapolis.
- Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team.