Career Opportunities

Career Opportunities

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.

Drug Safety Physician

Location: South San Francisco, CA or Stamford, CT or Remote

Reports To:

Executive Director, Medical

Position Summary

Loxo Oncology at 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 Oncology at 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 Boulder, CO, Indianapolis, IN, New York City, South San Francisco, 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 Oncology at Lilly 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 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.
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 each role and responsibility 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.

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