Medical Affairs Leader & CRS/CRP - ONCOLOGY

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 39,000 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.

Eli Lilly Canada is currently searching for a capable Medical Affairs Leader for our Oncology team with a dual role as a Clinical Research Scientist or Physician. 

At Lilly, we’re, inspired to make a difference in people’s lives every day – through the discovery of life-changing medicines, better understanding of disease management and support for people living with illness and their families and friends.

Our work today – from our research programs to our volunteer initiatives – is a reflection of our heritage of uniting caring with discovery to make life better for people around the world.

We are committed to investing in our employees – through competitive salaries, training and development, health, and the opportunity to make life better. The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable people to help us accomplish our mission!

ONCOLOGY MEDICAL AFFAIRS MANAGER/LEADER

The Oncology Medical Affairs Manager/Leader is responsible for effective and compliant implementation of the Medical Liaison and Medical Education program within the oncology therapeutic area. He/she has direct supervisory responsibility for a team of field­ based Medical Liaisons and Medical Education Associates who represent a specific regional area, therapeutic area component, or other segment of the overall Medical Affairs program.

The Medical Affairs Manager is responsible for managing the performance and development of the members of their team, overseeing the compliance, quality and effectiveness of field operations, and implementing strategic plans to optimize the team's performance. The Medical Affairs Manager is also responsible for establishing and maintaining effective communication and partnerships with field medical and internal colleagues to leverage the team's expertise to appropriately support strategic objectives and initiatives.

CORE RESPONSIBILITIES:

Effective People Management and Development

• Recruits for staff positions to meet business needs while leveraging diverse global talent pool.

• Supervises direct reports and facilitate performance management, personnel development, and career development through frequent 1:1 interactions, coaching, field visits and transparent feedback.

• Participates and represents staff in succession planning activities, talent assessment, merit pay, promotion processes, and reward and recognition activities to retain and motivate staff.

• Ensures staff compliance with Lilly Corporate, Medical, Regulatory and other standards, procedures, and other internal and external business and compliance requirements, including training requirements.

• Oversees the development and implementation of the required training for new and existing staff, reflecting scientific content skills needed for successful Scientific Expert interactions and functional expertise. 

• Creates a culture of accountability, excellence, and integrity.

Manage Field Operations – Maximizing Operational Effectiveness and Team Performance

• Oversees geographical management and MSL and MEA commitment and effectiveness in developing and maintain relationships with Scientific Experts (SE) and other external customers.

• Ensures team compliance with applicable laws, local guidelines and Lilly policies and procedures

• Deploys necessary tools, processes and other resources to enable successful field activities

• Creates and executes strategic plans to optimize team performance

• Identifies, develops and implements specific initiatives to enhance the team’s medical expertise, improve team dynamics, boost efficiency and achieve overall objectives

• Ensures close collaboration and alignment with the Sr. Medical Director and other local and global medical colleagues.

Establish and Maintain Effective Communication and Partnerships

• Participates as an active member of brand team and partners effectively with other cross-functional teams.

• Establishes and maintains effective communication and partnerships with field medical and internal colleagues to leverage team’s expertise to appropriately support strategic objectives and initiatives

• Oversees collection and communication of scientific intelligence, clinical insights and other field input to better inform decision making by internal partners.

• Collaborates with functional capabilities leader, operations manager and other members of Medical leadership team to share best practices.

• Builds and maintains long-term relationships with key internal and external business partners, supporting and driving organizational change and learning, anticipating future trends/needs, implementing sourcing strategies, strengthening current and future capabilities/tools/technology.

• Develops synergies with local, regional and global partners.

Customer and Business Planning

• Partners with cross functional and medical partners to align strategies and priorities as part of planning process

• Collaborates to ensure appropriate resources are obtained for team activities and operational needs,

• Oversees medical brand budget in conjunction with the Operations Manager and Sr. Medical Director

Other Medical Activities

• Special Projects as needed

CLINICAL RESEARCH SCIENTIST/CLINICAL RESEARCH PHYSICIAN

Through the application of scientific and clinical training and expertise, the Clinical Research Scientist (CRS) or 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 activities to meet patients' needs and ultimately enhance the customers' (patients, HCPs and payers) experience in interacting with the company. The primary responsibility of the Oncology Medical Affairs CRS/CRP is to provide expert scientific and clinical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company.

The core 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 in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.

• Contribute to the development of medical strategies 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 clinical 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.

• 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, 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 liaisons and medical education managers.

• 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.

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 Sr. Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, 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 Evidence, 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).

• 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 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

• 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 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 local label. Provide medical expertise to regulatory scientists.

• Support I 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 / 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.

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 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, and retention and hiring efforts as applicable.

• Participate in committees, and task forces as requested by business unit/corporate management.

• Model the leadership behaviors.

• Be an ambassador of both patients and the Lilly Brand.

QUALIFICATIONS AND EXPERIENCE

• Advanced degree in health sciences (PhD, MD, Pharm D) with 2-3 years of relevant clinical or therapeutic experience in oncology or internal medicine preferred

• OR MSc in health care/professional designation (BScN, PT, RD etc.) considered if 5 or more years of relevant clinical experience in oncology

• Preference given to individuals meeting the above with previous MSL or MEA experience in the field of oncology and sound knowledge of the pharmaceutical industry

Basic Requirements: 

• Intellectual curiosity and intelligence about the field of oncology

• Ability to critically appraise scientific information / literature

• Strong presentation skills including the ability to comprehend large amounts of scientific content which is then communicated in a clear, concise fashion

• Demonstrated ability to build strong/collaborative peer-to-peer relationships with external customers

• Familiarity with the academic community and medical research

• Significant direct experience in servicing customer needs for complex information

• Experience in professional networking with positive mutually beneficial outcomes

  • Strong collaborative and interpersonal skills including an ability to work effectively with internal colleagues, cross-functional team members, and external partners (co-promotions with other companies)

  • Strong project management skills with an ability to work within teams to prioritize key projects and medical tactics

Additional Preferences:

• Previous Medical Science Liaison experience in other fields

• Significant clinical or research work in the area of oncology

• Existing relationships with Scientific Experts in the field of oncology

• Located in Ontario

Eli Lilly Canada is committed to employment equity.  We encourage applications from qualified women, members of visible minorities, aboriginal peoples, and persons with disabilities

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 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.