Lilly Advisor-Clinical Research Scientist in West Ryde, Australia
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 35,000 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.
Imagine working in an intellectually stimulating environment for an innovation-based company that makes life better for people around the world. That’s Lilly.
For two consecutive years (2021 and 2022), Lilly Australia has been recognised as one of the best places to work at the Australian HR Awards.
In 2022 Lilly won the Best Corporate Social Responsibility Award at the PRIME Awards.
For the sixth year in a row, Lilly has been recognised as one of the World’s Most Ethical Companies by Ethisphere.
Fortune and IDEA Pharma has recognised Lilly as Number 1 in the Pharmaceutical Innovation Index.
Diversity Inc. has recognised Lilly as number three in Top 50 Companies for diversity.
Lilly currently has one of the strongest mid-to-late stage pipelines in our history, creating greater excitement and bigger and better career opportunities throughout our organization. Join us and develop your career through a variety of powerful learning and growth experiences — and enjoy considerable perks and benefits including a variety of health and wellness programs.
Whoever you are, wherever you’re from, if you want to make life better for people around the world, you belong at Lilly.
Through the application of scientific and clinical training and expertise, the -Advisor Clinical Research Scientist (CRS) is an integral member of the medical affairs, development, or a business unit brand team for strategic planning in the support of launch and commercialization activities to meet patients’ needs and ultimately enhance the customer experience.
KEY RESPONSIBILITIES & ACCOUNTABILITIES
Business/ customer support (pre- and post-launch support)
Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers)
Actively address customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel, and other cross-functional management during the development of the local business plan.
Scientific Data Dissemination/Exchange
Knowledge of and compliance with local laws and regulations, global policies and procedures, compliance guidelines with respect to data dissemination, and interactions with external health care professionals.
Understand and actively address the unsolicited scientific information needs of external health care professionals according to the guidelines above.
Support the planning of symposia, advisory board meetings, and/or the facilitation of other meetings with health care professionals.
Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM /Translational Medicine teams.
Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes).
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.
Clinical Research/Trial Execution and Support
Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects.
Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists, and selected investigators in the development of protocols and data collection requirements.
Regulatory Support Activities
Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of the local labels. Provide medical expertise to regulatory scientists.
Support / assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective.
Launch Readiness Planning
- The medical launch leader is responsible for the strategy, planning, and execution of those medical activities that will complement registration studies in achieving successful product launches and increasing benefits to patients. The focus of the launch leader and her/his supporting team is on the needs and education of payers, prescribers, and the other stakeholders who influence patients’ treatment access or benefit.
KEY COMPETENCIES & SELECTION CRITERIA
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, Ph.D., MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following:
3-5 years of clinical experience or
3-5 years of pharmaceutical experience (2 of which is in clinical development)
Have a BS or Masters degree in health/medical/scientific or related field and 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 experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
If experience is either in 2 and or 3 only (for example, no clinical trial experience), the following must be provided as supporting evidence of candidates ability/capability to perform in a MA role
Clear evidence and documentation of the candidate’s direct role and contribution to medical content. This should include evidence of the candidate as the medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific, or clinical information)
Candidate’s selection for MA role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team
COVID-19 VACCINATION REQUIREMENT
As a condition of employment with Eli Lilly Australia and Eli Lilly New Zealand, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an exemption on medical or other grounds, you may do so by emailing ANZ_HR@lilly.com
LIFE AT LILLY
We are committed to investing in our employees, through competitive salaries, development and training, generous benefits, and the opportunity to make an impact on the world.
Our total rewards programs are designed for your overall well-being, supporting you wherever you are in your life and career journey- offering flexibility and choice to help you be the best you. We grow and lead at all levels of the company, where unleashing your potential means exploring cutting-edge solutions and investing in your development, no matter what job, title, or tenure you have.
Whoever you are, wherever you’re from, if you want to make life better for people around the world, you belong at Lilly. Learn more at www.lilly.com.au
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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