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Senior Director Medical Affairs Oncology Poland
  • warszawa
Senior Director Medical Affairs Oncology Poland
Warszawa, warszawa, Polska
Eli Lilly and Company
15. 5. 2022
Informacje o stanowisku

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.

Clinical Research Physician – Medical Affairs

Purpose:

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. The CRP may also work closely with global Development teams, Therapeutic Area

Program Phase, Early Phase/Clinical Pharmacology, 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 contributing to

the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and

reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; 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, Early Phase/ Clinical Pharmacology, and Translational Medicine team(s).

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 of the medical team (and direct reports, if applicable) 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 government agencies (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 latephase

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 affiliates/countries 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.

1. 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 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 (for example, Diabetes Nurse Educators

Service).

▪ Participate in local or national trade associations, as appropriate.

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 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.

3. Clinical Planning

▪ 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, global Medical Affairs and Development teams, Global Patient Outcomes/Real World

Experience, PAA, 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 Experience, and PAA 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.

4. 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, as requested Contribute to global alignment of Phase 3b/4 clinical studies

(and Phase I and II studies where applicable) planned by country(ies) or global Development team.

▪ 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.

5. 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).

6. 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 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.

7. 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 contribute to the development of others by

being an active source of coaching and feedback to co-workers, and direct reports as applicable.

▪ Collaborate proactively and productively with all alliance, 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

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