Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.
The Senior Director, Drug Safety Operations is responsible for pharmacovigilance activities involving the Company's products and/or clinical trials. This individual will be responsible for managing individual adverse events (AE) cases, including review, processing and evaluation of safety reports. Additional duties include participating in the safety surveillance program for investigational products, providing line management to Drug Safety Operations team as well as managing technical functions at a cross functional level.
**Roles and Responsibilities of the Position**
+ Oversee the proper and timely collection and reporting of AE information from all sources.
+ Assist in the preparation and management of aggregate safety reports (e.g. IND safety reports, DSURs, PSLLs etc.).
+ Perform medical review of AEs/SAEs from clinical trials, interfacing with reporters as needed.
+ Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, ICFs, CSRs, IBs and other documents as needed.
+ Review of protocols, case report forms, guidelines, CSRs and manuscripts as requested.
+ Assist with the development and maintenance of pharmacovigilance related SOPs, policies and work instructions.
+ Create and track case processing metrics for internal monthly safety reports.
+ Contribute to regulatory authority submissions by reviewing safety data and assisting in the preparation of relevant sections.
+ Participate in regulatory and inspections/audits as it relates to pharmacovigilance activities.
+ Collaborate cross functionally with other departments including clinical, biostatistics, data management, clinical operations and regulatory affairs with respect to safety related issues.
+ Liaise to provide drug safety oversight of processes overseen by vendors.
+ Participate in addressing drug safety-related questions from Regulators or to support Company internally.
+ Provide Management and oversight to direct reports.
**Background Requirements and Preferred Qualifications**
+ Health science degree required: Nursing (RN, BSN, MSN or NP), PA, RPH, PharmD, or MD
+ Minimum of 12+ years of experience required in the pharmaceutical industry or CRO, along with 5+ years in drug safety, pharmacovigilance and risk assessment (or relevant experience).
+ Experience in the management of safety information originating from clinical trials and post-marketing sources.
+ Experience in Hematology/Oncology desired.
+ Experience and working knowledge of Good Pharmacovigilance Practices (GPvP) required.
+ Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
+ Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for both clinical trial and post-marketing environments.
+ Ability to interpret scientific and clinical trial data.
+ Strong verbal and written communications and presentation skills.
+ Proven problem solving, decision-making and interpersonal skills.
+ Detailed knowledge of drug safety databases.
+ Expertise working with MedDRA.
+ Possess strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
+ Proficiency in MS Office Suite.
+ Strong ability to prioritize tasks and keen attention to detail.
+ Ability to be both enterprising and resourceful.
+ Proven ability to work on multiple projects in a fast-paced environment.
_Loxo@Lilly currently anticipates that the base salary for the Senior Director level position could range from between $144,000 to $211,200 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described._
The physical demands of this job are consistent with light office duties.
_The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job._
This position's work environment is in the employee's home office.
_The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job._
_*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions._
_Loxo@Lilly (Eli Lilly and Company) 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._
_As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law)._
_Loxo@Lilly (Eli Lilly and Company) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email_ [ Email address blocked ] - Click here to apply to Senior Director, Drug Safety Operations
_for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response._
- Attention To Detail
- Case Report Forms
- Clinical Trials
- Clinical Works