Career Opportunities

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Reports To:

Associate Director, Clinical Scientist

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.

This position offers the opportunity to participate in the entire spectrum of the drug development process. We design our drugs “from the ground up”, starting with the selection of a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. In your role, you will have the opportunity to move this drug “from the bench to the bedside”, from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval. You will participate directly in improving the lives of people fighting their cancers.

In your role, you will team with the medical monitor and other team members to design, implement execute and analyze results for Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as you will interact with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.

We are a small company, but we are highly focused on clinical and regulatory execution. As a key member of our team, you will have the opportunity to work and learn in a fast-paced, team-oriented and exciting work environment that will literally change the lives of cancer patients for the better.

The Senior Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring of clinical development programs. These programs include early proof of concept through registration in a variety of targets and may involve collaborations with corporate development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities. 

Roles and Responsibilities of the Position*

• Serve as the clinical science representative on global and regional clinical execution teams.
• Create and foster strong strategic partnerships with colleagues that include Clinical Operations/Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management and pre-Clinical Development. 
• Lead the design and interpretation of clinical trials. 
• Assist in the writing and/or development of protocols, informed consent forms, case report forms, Statistical Analysis Plans, Data Management plans, clinical study reports and regulatory-related documents.
• Assistance in the development of abstracts, manuscripts, study/program design and presentations; collaborate with external consultants as needed.
• Review, interpret, and present clinical data from development program and the relevant literature at relevant scientific meetings.
• Support the writing of subsequent regulatory briefing documents.
• Lead and accountable for interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.  
•  Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
• Along with Clinical Operations, work closely and liaise regularly with clinical sites and investigators to oversee study enrollment and success in clinical trials
• Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
• Proactively generate ideas for improvements and take action to solve problems and achieve goals beyond what is required.

Required Qualifications and Background

• PhD, PharmD or M.D.
• The ideal candidate will have 5 years of biopharma experience in an academic or industry setting and at least 2+ years’ medical/clinical scientist experience in oncology. At least 5 years’ clinical research experience preferred, particularly in drug development in oncology.
• Clinical trial expertise along with experience in oncology with drug development highly desirable. Must possess a strong background in clinical trials in an academic or industry setting.
• Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.
• The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.
• The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.
• 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.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications.

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.

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.

For more information about Loxo Oncology’s privacy practice, please view the Privacy Statement.

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