Executive Director, Drug Safety Operations
Posted on: January 28, 2023
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 Executive 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
- 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
- Create and track case processing metrics for internal monthly
- Contribute to regulatory authority submissions by reviewing
safety data and assisting in the preparation of relevant
- 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
- 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 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
- 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
- Proven problem solving, decision-making and interpersonal
- 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
- 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 Executive Director level position could range from between
$158,250 to $232,100 and will depend, in part, on the successful
candidates 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.*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
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.
Keywords: Loxo@Lilly, Denver , Executive Director, Drug Safety Operations, Executive , Denver, Colorado
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