Director Medical Affairs IBU Alliance CMH

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Role Overview

Through the application of scientific and clinical training and expertise, the Alliances Lead Physician for CMH is an integral member of the medical affairs Alliances 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 Alliances Lead Physician for CMH. The Alliances Lead Physician for CMH will also work closely with Global / IBU teams in the Therapeutic Area of CMH and leads the Alliances Lilly CMH expert community, having direct reports.

In addition, they are responsible for ensuring that their activities are clearly aligned with the strategic priorities of the Medical Affairs Global/IBU brand team(s) for CMH as the therapeutic area of responsibility.

The Alliances Lead Physician for CMH and their team serve as a scientific resource for partners as needed in a cross-functional environment. The Alliances Lead Physician for CMH is aware and ensures that all activities of the alliances medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance, 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.

Key Responsibilities

The primary responsibility of the Alliances Lead Physician for CMH is to provide expert scientific and clinical support to all aspects of the CMH regional business, to ultimately enhance the customers' experience in interacting with the company.

The Key Priority Areas Include

Thought Leader and CMH Specialists support (pre, peri, and post-launch support):

• Understand and anticipate the scientific information needs (payers, patients, health care providers) and actively address their questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
• Development and implementation 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 regional business plan.
  
  
  

Medical Affairs Planning Support

• Leverage deep product/disease knowledge and educate the network of peers, so they are ready to support their launches.
• By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team at the Alliances regional level.
  
  
  

Clinical Planning & Clinical Research/Trial Execution And Support

• 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.
• 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).
  
  
  

Scientific Data Dissemination / Exchange, Training, And Education

• 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/or the facilitation of other meetings with health care professionals at Alliances level.
• Support medical information associates in preparation and review of medical letters and other medical information materials.
• 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.
  
  
  

Regulatory Support Activities

• Participate in development and review of local labelling and labelling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label.
• Provide medical expertise to regulatory scientists.
• Participate in advisory committees.
  
  
  

Job Requirements

• Deep scientific expertise and knowledge of CMH and its treatment.
• Comfortable in interpreting technical scientific/medical data/research and communicating with credibility, with good presentation skills.
• Understanding of the CMH customer and CMH business, with strong planning and execution skills.
• Comfortable in interpreting technical scientific/medical data/research and communicating with credibility, with good presentation skills.
• Evidence of good teamwork in a cross-functional environment and interpersonal skills.
• Strong communication, organizational and negotiation skills
• People management skills.
• Willingness to travel to customers, meetings, and congresses within the Alliances and international
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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