Loxo@Lilly Associate Director, Safety Operations in Augusta, Maine
Loxo@Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo@Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Associate Director, Safety Operations is responsible for pharmacovigilance activities involving the Company's products and/or clinical trials. The Associate Director, Safety Operations will manage 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 and assisting with the responsibility of managing technical functions at a cross functional level.
Roles and Responsibilities for 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
Mentor and train junior team members
May have direct reports
Required Qualifications and Preferred Background:
Health science degree: Nursing (RN, BSN, MSN or NP), RPH, PharmD, PA or MD
Minimum of 7 years of experience in the pharmaceutical industry or CRO, 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 Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Director level position could range from between $135,300 to $198,516 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.
South San Francisco, CA
Remote (US Based only)
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.
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 Oncology, Inc. 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 Oncology, Inc. (“Loxo”) 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 firstname.lastname@example.org 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.