Senior Director

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Clinical Research Physician (CRP)* - Medical Immunology

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Business Unit- Medical Affairs Clinical Research Physician (CRP) 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 customers' experience in interacting with the company.

The definition of "customer" here includes patients, providers (HCPs) and payers. Specific activities include developing or contributing to the medical plan in his/her therapeutic area of responsibility, supporting the development, conduct and reporting of local clinical trials; the reporting of adverse events as mandated by corporate patient safety; 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; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase.

The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Physician is aware of and ensures that all activities in medical affairs are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), 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: 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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibility of the Business Unit - Medical Affairs CRP is to provide expert medical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with Cofepris, if necessary (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for pricing, reimbursement and access(PRA) (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late­ phase and marketed compounds, but can also include early phase trials (for example, phase I and II trials). The CRP is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non clinical trial solutions/activities that are conducted in the affiliates as described in the clinical plan. In addition, the CRP, if assigned by the Director­ Medical and/or Regional Medical Leader, is responsible for support of global Development studies conducted in affiliates/countries. 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 (core and post launch support)

Understand and anticipate the scientific information needs of all local 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 a scientific and medical expert 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 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 patient advocate, as well as a medical expert.

Understand and apply knowledge of customer insights to all customer-related activities.

Provide medical insight and training to patient support programs.

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 or media requests.

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 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 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, if necessary.

Clinical Planning

Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Experience, 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), if needed.

Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

Represent the clinical needs of Mexico 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 Scientists (CRSs), regional clinical operations staff, statisticians, health 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 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 IIT proposals and publications.

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 local label.

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).

Scientific I Technical Expertise and continued development

Be aware of current trends and projections for clinical practice and access in the atopic dermatitis disease and other related immune pathologies 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

Be accountable for the medical budget of the Therapeutic Area.

Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers.

Collaborate proactively and productively with business, and vendor partners / cross/functional work

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.

Actively participate in recruitment, diversity, and retention efforts, and hiring efforts as applicable.

Model the leadership behaviors.

Be an ambassador of both patients and the Lilly Brand.

Launch Support

Key skills/requirements:

Needs deep knowledge of molecule and existing development plan

Will need to be well versed on trial(s) results and conclusions, thus will need to work closely with submission teams

Ideally would be partnered with an affiliate headcount sitting within the team who can go back to the region to establish the medical brand team prior to launch - seed the region with experience

Thought leader engagement and relationships will be essential - shared and coordinated responsibility between Global Product Team (GPT) and regions and functions

Works cross-functionally and cross geography

Need strong scientific expertise and people skills

Must have an understanding of dermatology and other specialties related to atopic dermatitis, understanding of the business, with strong planning and execution skills

Key responsibilities:

Be a single point of contact for the overall molecule medical affairs

Scientific Platform/Communications Strategy/SOD 3b/4 studies and their supportive study plans Training and education Internal (molecule, MOA, disease state ) External (Disease State) Global Thought Leader plans - in close collaboration with regions and affiliates

Leading medical affairs pre- peri- and post launch activities

Leverage deep product knowledge and educate the network of local affiliate peers, so they are ready to support their local launches.

Work collaboratively with the teams of International Therapeutic Area Lead in Immunology and Marketing team to ensure robust Brand planning.

Minimum Qualification Requirements:

Medical Doctor. Dermatologist or MsC / PhD with at least 5 years of experience working in this TA

Demonstrated ability to balance scientific priorities with business priorities

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.

Fluent in English, verbal and written communication.

Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader.

Corporate or regional patient safety physician(s)

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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