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Advisor-Research Scientist-Clinical Medical Affairs
2 months ago
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 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.
Clinical Research Scientist – Medical Affairs
Through the application of scientific and clinical training and expertise, the Clinical Research Scientist (CRS) is an integral member of the medical affairs team in the support of commercialization activities to meet patients' needs and ultimately improve the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs) and payers. The CRS may also work closely with global Development teams, Therapeutic Area Program Phase, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases. Specific activities include developing or chipping in to the global and/or regional clinical/medical plan in their therapeutic area of responsibility, publications and data dissemination for products; the outreach medical activities aimed at the external clinical customer community, including leaders with vision; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician Medical Leader, the CRS is responsible for assuring that their activities are clearly aligned with the priorities of the Medical Affairs business unit brand team(s) and Therapeutic Area Program Phase. The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team are following current local and international regulations, laws, guidance (for example, FDA), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.Primary Responsibilities:
The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the business, to ultimately improve the customers' experience in interacting with the company. This includes marketed product support (be active in the strategic plan for the compound), leading in local scientific data dissemination (leading and speaking publicly at conferences, advisory boards, etc., and leading all aspects of the development of the content of programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (II trials). The CRS is responsible for collaborating with the global and affiliate teams in the planning, startup and conduct of phase 3b/4 studies, as well as non-clinical trial solutions/activities that are conducted in the clinical plan.
The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.
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 promptly and 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 other groups in Medical Affairs and brand teams, Value Based Outcomes and PRA, clinical management and other cross-functional individuals during the development of the local business plan.
- As the scientific and clinical expert, help with activities and deliverables in an ongoing basis for currently marketed brands.
- By offering scientific and creative input, help with the development, review, and approval of promotional materials for the brand team.
- Support training of sales representatives, and other medical representatives.
- Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on their medical knowledge. Become patient advocate, as well as a medical expert.
- Understand and apply knowledge of customer insights to all customer-related activities.2. 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.
- Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
- Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.
- Support medical information associates in preparation and review of medical letters and other medical information materials.
- Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff.
- Prepare or review scientific information in response to customer questions
- Provide follow-up to information requested by health care professionals as per global SOPs
- Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
- Establish collaborations and relationships with external scientific experts, professional societies, leaders with vision, and the general medical community on a local, national, regional, and possibly international basis.
- Support the design of customer research as medical expert.
- Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet leaders with a point of view, and be involved in customer events).
- Be involved in data analyses, development of scientific data dissemination, and preparation of final reports and publications.3. Clinical Research, Planning, execution and Support
- Communicate and collaborate with Director-Medical and Business Unit Physician Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated.
- 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 clinical programs meet the needs of local/regional customers.
- 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.
- Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
- Assist in the planning process and get involved in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.
- Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Review lIT proposals and publications, as requested
- Understand and actively address the scientific information needs of all investigators and personnel.4. Scientific / Technical Expertise and continued development
- Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years).
- 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.
- Responsible for the scientific training of the clinical study and medical affairs teams
- Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
- Explore and take advantage of opportunities for extramural scientific experiences.
- Attend and play a part medical congresses/scientific symposia.5. General Responsibilities
- Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget.
- Actively set and meet individual professional development goals and chip in to the development of others by being an active source of coaching and feedback to co-workers, by providing constructive feedback, in the spirit of development, increased team effectiveness and cohesiveness
- Collaborate proactively and efficiently with all business, and vendor partners.
- Model the leadership behaviors.
- Be an ambassador of both patients and the Lilly Brand.Minimum Qualification Requirements:
An advanced health/medical/scientific or related graduate degree such as DVM, PharmD, PhD, 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 medical affairs)Or
Have a BS or master’s 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), clear evidence and documentation of candidate's direct role and contribution to medical content must be provided as supporting evidence of candidate ability/capability to perform in a CRS role
- This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
-Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
-Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
-Demonstrated strong communication, interpersonal, teamwork, organizational and adaptability skills
-Showcase skills 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 for team support
- Proficiency in English, including verbal and written communication skills
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 ( Lilly_Recruiting_Compliance@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 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.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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- This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
