TAIPEI, Taipei City, Taiwan
20 days ago
Clinical Research Scientist

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.

Company Overview

Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better."

More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live.

We’ve received recognition from several distinguished organizations for our efforts. Here are some of our honors in recent years:

Catalyst Award, for our innovative Employee Journeys and People StrategyCorporate Knights, Global 100 Most Sustainable Corporations in the WorldEthisphere, World's Most Ethical Companies 2019 – 3rd year in a rowForbes, America's Best Employers for Diversity

About Lilly Taiwan

Here at Lilly, we are focused on our common purpose to make life better for people around the world. Whether here in Taiwan, the greater NAPAC region, or our corporate headquarters in Indianapolis, each team member plays a critical role in ensuring we deliver on that purpose.

The Lilly Taiwan team is an exciting and fulfilling place, where we work hard to change lives for patients while supporting and encouraging each other to be and bring our best. Lilly is a place you can grow and lead, innovate, connect with coworkers who care about you and find meaning in the work you do. Join us.

Responsibility:

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.Contribute as scientific and clinical expertise to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.Support business-to-business and business-to-government activities as a medical expert.Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.Support training of sales representatives, and other medical representatives.Become familiar with market archetypes and potential influence on the medical interventions for the product.Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge.  Become a patient advocate, as well as a medical expert.Provide medical insight and training to patient support programs. Understand and apply knowledge of customer insights to all customer-related activities.

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.Support medical information associates in the preparation and review of medical letters and other medical information materials.Support reviewing materials related to external communications.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 or media requests.Provide follow-up to the 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 and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.Develop and maintain appropriate collaborations and relationships with relevant professional societies.Support the design of customer research as a medical expert.Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.Participate in reporting of clinical trial data in Clinical Trial Registry activities.

Clinical Planning

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.Participate in investigator identification and selection, in conjunction with clinical teams.Ensure that the clinical operations 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.Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.Serve as a resource to clinical research site monitors, investigators, and ethical review boards to address any questions or clarify issues arising during the conduct of the study.Review IIT proposals and publications, as requested  Contribute to the global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country (ies) or global Development and Medical Affairs teams.Understand and actively address the scientific information needs of all investigators and personnel.Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.

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.Participate in advisory committees.Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).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 team.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, contribute, and participate in medical congresses/scientific symposia.

General Responsibilities

Collaborate proactively and productively with all, business, and vendor partners.Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness.As applicable, works closely with direct reports on performance management plans (objectives), development plans, and documentation of their expertise. Keeps these documents and plans up to date. Meets regularly with each direct report to coach, mentor, evaluate performance, evaluate training and development needs, and monitor career development goals. Maximizes each individual direct report’s career potential, maximizing the value to the organization.Actively participate in recruitment, diversity, retention, and hiring efforts as applicable.Participate in committees, Six Sigma initiatives, and task-forces as requested by business unit/corporate management.Model the leadership behaviors.Be an ambassador of both patients and the Lilly Brand.

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.

Collaborate with global brand development teams, Business Unit Team Physician/Regional Medical leader, and local cross-functional team members for launch preparation.  This will include medical strategic guidance for the following brand development activities:

Insights (Insights, Patient Segmentation, Competitive Landscape, Patient journey, etc)Local positioning, brand planning, Scientific Story, etc.Local Commercialization activities (Brand Planning, Promotional Messages, etc)Responsible for launch readiness capability, partner with cross-functional teams to develop launch readiness plan including recommended capacity, tactics and OPEX to support successful launch.

Qualifications:

An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as PharmD, Ph.D.3-5 years of clinical experience or 3-5 years of pharmaceutical experience. (2 of which is in clinical development)Demonstrated ability to balance scientific priorities with business priorities.Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills.Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.Fluent in English, verbal and written communication

Additional Skills/Preferences

Pharmaceutical experiences in auto immune diseases (specifically rheumatology and dermatology fields)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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