Director/Senior Director, Biostatistics
PATHOS
Clinical Research Scientist, Medical Affairs – Immunology
Eli Lilly and Company
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $168,000 - $294,800 per year
Job Level
SeniorLead
About the role
- Provide expert scientific and clinical support to local business and medical affairs to enhance customer experience (patients, providers, payers)
- Develop or contribute to global/regional clinical/medical plans and support launch and commercialization activities
- Develop, conduct, and report local clinical trials; implement global clinical trials in local affiliates/countries
- Report adverse events per corporate patient safety policies and supervise patient safety during studies
- Review protocols, study reports, publications, informed consent documents, and labeling; provide medical support for regulatory submissions
- Provide medical input for pricing, reimbursement, and access (PRA) materials and interact with PRA agencies
- Lead local scientific data dissemination (congresses, symposia, advisory boards, publications, slide sets)
- Support medical information preparation and review and train sales and medical personnel
- Collaborate with global Development, Medical Affairs, Global Patient Outcomes/Real World Evidence, and other cross-functional teams on clinical planning and study design
- Serve as scientific resource and consultant for study teams, investigators, ethical review boards, and clinical operations
- Support investigator identification/selection, study start-up, and site training; ensure administrative/regulatory requirements are met
- Participate in local medical budget preparation, mentorship, recruitment, diversity and retention efforts, and act as Lilly brand ambassador
Requirements
- Advanced health/medical/scientific or related graduate degree (for example, DVM, PharmD, PhD, MSN with advanced clinical specialty) and one of the following: at least 10-15 years of clinical experience OR 10-15 years of pharmaceutical experience (preferably in Medical Affairs)
- OR Have a BS or Master's degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience directly related to clinical trial experience or drug/clinical development (e.g., epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
- If experience is lacking clinical trial experience, must provide clear evidence and documentation of direct role and contribution to medical content and endorsement by BU Med affairs/development VP or equivalent senior leadership
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
- Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
- Demonstrated ability to influence others (both cross-functionally and within the function)
- 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
- Knowledge of and compliance with local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP), Good Clinical Practices (GCPs), company standards, policies and procedures
