Job Information
Loxo@Lilly Senior Director, Clinical Quality Assurance in Harrisburg, Pennsylvania
About Loxo@Lilly:
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, Clinical Quality Assurance is responsible for end-to-end Clinical Quality Assurance. The Senior Director, Clinical Quality Assurance will be responsible for the oversight and execution of third-party qualifications, inspection readiness program, quality plans, policies and quality system elements related to clinical quality activities in support of clinical programs. The Senior Director, Clinical Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a international regulatory environment and provide guidance in clinical Quality related areas.
Roles and Responsibilities:
Responsible for leading the clinical Quality team which includes third party and internal auditing and day to day clinical study team support.
Liaise across Loxo@Lilly departments and with Lilly colleagues to proactively identify opportunities to streamline and strengthen clinical Quality process.
Reviews and approves internal and external audit reports, Quality Events and associated Corrective and Preventative Actions within a regulated Quality Management System.
Represents Clinical Quality expertise across the Loxo @Lilly development organization in GCLP and GCP.
Keeps current with global health authority laws and regulations; identifies gaps and implements process improvements resulting from new/revised regulations or guidance.
Reviews study team and regulatory documentation as requested (e.g., Data Management, Operations, Safety, Regulatory, etc.).
Leads external Health Authority inspections and internal audits
Provides guidance in global regulatory reporting requirements (e.g. serious breach, etc).
Establishes a global inspection readiness program.
Required Qualifications and Preferred Background:
Bachelor’s degree with 15 or more years’ experience working in clinical development, preferably in either a clinical compliance or clinical Quality Assurance.
Must be strategic as well as a hands-on leader who can see “the big picture” while providing guidance to execute daily tasks
Must have experience in managing a team of QA professionals
Demonstrated Quality Management System experience appropriate for the clinical development.
Demonstrated understanding in third party/internal Quality audits, Issue Management and CAPA in a clinical environment.
Experience leading FDA or other Health Authority Inspections
Strong knowledge of global clinical trial regulations (e.g. ICH, FDA, etc) and guidelines, particularly in GCLP, CAP, CLIA and GCP
Proficient in risk management principles
Self-motivated with the ability to work effectively in a dynamic environment
Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization to provide solutions to complex situations.
Excellent critical thinking and problem-solving skills and strong collaborator.
Ability to effectively manage multiple priorities with a sense of urgency
Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
Attention to detail and accuracy of work.
Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
Strong communication skills both written and oral.
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Director level position could range from between $144,000 to $211,100 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.
Physical Demands/ Travel:
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.
Work Environment:
This position’s work environment is in an office setting with up to 25% travel required.
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.
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 loxoaccommodation@loxooncology.com 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.