Assoc Medical Advisor

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
January 18 2019
Ref
46827BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
Through application of scientific training, clinical expertise, and relevant experience, the Neuroscience Design Hub Clinical Senior Research Physician/ Medical Fellow participates in the development of corporate/global clinical trials in support of the development through Phases 1 to 3, up to registration for neuroscience products with a particular focus on Lilly's growing pain portfolio. The Senior CRP will lead the efforts in innovative trial design, leveraging contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the global strategy for the product; and various medical activities in support of demand realization.
The Sr Clinical Research Physician/ Medical Fellow must have deep understanding of neuroscience, in particular pain, physiology and clinical study design. He/She must also be aware of novel ideas, be willing to interact and learn from different teams, including other therapeutic areas. He/She must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidances (e.g. FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and Principles of Medical Research.

Core Job Responsibilities
  • The primary responsibilities of the Neuroscience Design Hub Sr CRP are generally related to Phase I to IV compounds.
  • The core job responsibilities include those listed below as well as all other duties as assigned.

Clinical Trial Design and Planning

  • Collaborate with the Neuroscience Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and design of innovative study protocols which address key needs (registration, patient, provider, and payer); the product lifecycle plan, clinical strategies.
  • Provide expert input into the creation of clinical trial design options, scenarios and the complete trial package.
  • Provide optimized-design and execution elements to enable cost effective science and best clinical development outcomes.
  • Drive and incorporate shared learning across assets, programs and other therapeutic area platforms
  • Understand and keep updated with the pre-clinical and clinical data relevant to neuroscience molecules.
  • Work closely with clinical operations, regulatory and safety in order to better design studies and programs which address the aforementioned goals.
  • Review risk profiles to ensure appropriate communication of risk to study subjects.
  • Participate in investigator identification and selection, in conjunction with asset teams.

Scientific Data Dissemination/Exchange

  • Knowledge of, and compliance with, local laws, regulations, global policies and procedures, and compliance guidelines with respect to data dissemination and interactions with external health care professionals.
  • Support advisory board meetings, and other meetings with health care professionals.
  • Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
  • Develop and maintain appropriate collaborations and relationships with relevant professional societies.

Scientific / Technical Expertise and continued development
  • Critically read and evaluate the relevant medical literature; and keep updated with medical and other scientific developments relevant to the product.
  • Be aware of current trends and projections for clinical research, and practice, and access in the therapeutic area(s) relevant to the product.
  • Attend scientific symposia.
General Responsibilities
  • 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.
  • Ensure that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
  • Model the leadership behaviors.
  • Be an ambassador for the Lilly Brand.

Company Overview
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.

Basic Qualifications
  • Medical Doctor. Must be board eligible or certified in relevant therapeutic areas (Neurology, Psychiatry or Anesthesiology) or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
  • Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
  • Clinical research or pharmaceutical medicine experience in neuroscience, in particular pain (5 years)

Additional Skills/Preferences
  • Knowledge of drug development process preferred.
  • Fluent in English; both written and verbal communications.
  • Interpersonal, organizational and negotiation skills.
  • Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
  • Excellent teamwork skills.
  • Willing to relocate to Indianapolis.
  • Willing to engage in limited domestic and international travel to the degree appropriate to support the business.

Primary internal interactions

  • Design Hub Advisors and Consultants
  • Director(s)-Clinical Operations, managers or project managers
  • Clinical planning, operations, CRPs/Ss, other research staff
  • Statisticians
  • Scientific Communication associates
  • Health outcomes research consultants/research scientists
  • Regulatory directors, scientists, and associates
  • Product directors, managers, and associates of the brand teams
  • Legal counsel
  • Therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Director-Medicals
  • Global Marketing director or manager
  • Corporate patient safety physician
External Contacts
  • Scientific and clinical experts, thought leaders
  • Lilly clinical investigators
  • Practicing physicians/prescribers
  • Regulatory agency personnel
  • Professional association staff and leaders
  • Disease advocates and lay organizations focused on relevant health issues

Additional Information
Lilly is an EEO/Affirmative Action Employer and 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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