Drug Safety Physician

at Loxo@Lilly in Dover, Delaware, United States

Job Description

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 Drug Safety Physician will lead and support the expansion of clinical development programs (or one large, complex program) in support of the overall product development plan with a focus on development of the safety profile. This physician will serve as an ambassador and resource to various physicians and clinical trial sites, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo@Lilly’s customers, markets, business operations, and emerging issues, and perform other responsibilities as requested.

Roles and Responsibilities of the Position:

+ Primary responsibility for daily safety case review and will contribute to the design, analysis, interpretation, and reporting of safety findings within a program and will review and contribute to the content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents

+ Primary responsibility for reviewing safety data periodically and on an ongoing basis to ensure quality control (QC) as required by program needs

+ May participate in or lead review of protocol deviations (PD) which may impact patient safety as required by program needs

+ May participate in, or lead safety development contributions to, due diligence or other business development activity. As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies

+ Actively solicits opinion leader interactions related to the disease area(s); partners with Clinical leads, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Safety Development Plans and protocols as appropriate

+ Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic and safety area. May represent Loxo at key external meetings

+ Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serve as a safety representative for key regulatory discussions

+ Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, organization policies and to all other quality standards in conducting research

Required Qualifications and Preferred Background:

+ MD, Board certified or eligible; PhD advantageous

+ At least 2 years of oncology experience strongly preferred

+ Ability to exercise judgment and address complex problems and create solutions for one or more projects

+ Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors

+ Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team

+ Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence

+ Proven ability to interact externally and internally to support a global scientific and business strategy

+ Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel

+ Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator

+ Strong communication skills both written and oral

+ Ability to multi-task and shift priorities rapidly to meet tight deadlines

+ Professional demeanor and appearance and an excellent written and verbal communicator

+ Good and thoughtful listener

+ Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies

Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $154,300 to $226,307 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will 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 above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties . This role will require 10-20% travel.

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 primary work environment is in an office / traveling in the field to both US and International locations as indicated.

The work environment characteristics described here are representative of those encountered by an employee 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 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.

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Job Posting: JC216982540

Posted On: Jun 24, 2022

Updated On: Jul 15, 2022