Director – Clinical Research Scientist Full-time NEW

Development Clinical Research Scientist

At Lilly, we unite caring with discovery to make life better for people around the world. 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.

Through the application of scientific training and clinical training and expertise, the Development Clinical Research Scientist (CRS) participates in:

• the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product(s);
• the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety;
• the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts;
• contacts with regulatory and other governmental agencies;
• outreach medical activities aimed at the external clinical customer community, including leaders with vision;
• the development and implementation of the business unit and global strategy for the product; and various medical activities.

The clinical research scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Coordinate with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

1) Clinical Planning

• Collaborate with cross-functional partners in clinical design, discovery, medical development, biostats, safety, PRA, clinical pharmacology, etc. in the development and maintenance of a product profile that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

2) Clinical Research/Trial/Execution and Support

• Plan, collaborate, 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.
• Provide protocol oversight and input into informed consent documents.
• Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
• 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).
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
• Assist in the planning process of study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
• Review external proposals and publications, as requested by CRP or Director-Medical

3) 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.
• Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
• Prepare or review scientific information in response to customer questions or media requests
• Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
• Establish and maintain appropriate collaborations and relationships with external 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 training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
• Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.

4) Regulatory support activities

• Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
• Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
• Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.

5) Business/customer support (or/and post launch support)

• Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates and other cross-functional management during the development of the local business plan.
• Actively address Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts.
• By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics, as needed.

6) Scientific I 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 or therapeutic area
• Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
• Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product
• Participate in the development and implementation of the business unit and global strategy for the therapeutic area

7) General Responsibilities

• Actively set and meet individual professional development goals and contribute to the development of others.
• Support the management team in preparation and administration of the business unit development plans and activities.
• Collaborate proactively and productively with all alliance, business and vendor partners.

Minimum Qualification Requirements:

A:

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 following:1. 3-5 years of clinical experience or2. 3-5 years of pharmaceutical experience (2 of which is in clinical development)

OR

B:

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:1. Clinical trial experience2. Experience in areas relevant to drug discovery3. 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 candidate's ability/capability to perform in a CRS role: