Medical Director, Clinical Diagnostics

Company: Loxo@Lilly
Location: Boise
Posted on: August 6, 2022

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 Medical Director, Clinical Diagnostics will provide practical clinical input to diagnostic strategy and support execution of that strategy for assigned precision medicine product launches. This role has specific focus on identifying unmet medical needs and determining best diagnostic strategies to minimize barriers to adoption of clinical biomarker testing for the program disease states in clinical trials, companion diagnostics development, product launch readiness and product lifecycle. Strategic planning and execution will include but is not limited to planning internal and external educational approaches, planning and executing on diagnostics related publications, engaging with thought leaders and professional societies, working closely with the companion diagnostics group to ensure clinical applicability of approach, serving as a subject matter expert on relevant product lead teams, and internal cross functional alignment with business unit teams. The Medical Director, Clinical Diagnostics will focus on understanding the diagnostic testing environment and the future state of diagnostic testing practices and technologies and building plans to address identified gaps which may impact patient enrollment to clinical trial, and adoption or utilization of appropriate biomarker tests throughout lifecycle. The Medical Director may help to inform diagnostic development strategy as well as support launch strategy for biomarker testing. This role provides expertise to a variety of diagnostic focused tasks and utilizes their expertise in clinical diagnostics to establish strong partnerships with internal and external stakeholders. Additionally, the Medical Director will provide cross functional support to address business needs of the development, clinical and commercial teams as it relates to diagnostic testing. Roles and Responsibilities of the Position: + Serve as Loxo's scientific representative to the pathology, diagnostic laboratory and medical communities; facilitate the appropriate exchange of scientific information+ Communicate clinical diagnostic and technology trends which may impact biomarker testing on both early and late phase assets+ Support companion diagnostic development timelines associated with assigned programs+ Provide content expertise through knowledge transfer and training materials to the medical affairs team in the development and implementation of the launch strategy for assigned programs+ Work closely and in synergy with product development teams as well as therapeutic medical affairs team+ Participate and support advisory boards and steering committees+ Provide support through development and/or review of field based diagnostic educational and promotional materials for scientific accuracy Required Qualifications and Preferred Background: + MD with formal Training in Anatomic Pathology, American Board of Pathology - Anatomic Pathology/Molecular Pathology board eligible or certified; and 3 + years of experience in a clinical lab setting+ Strong knowledge of pathology laboratory clinical diagnostic testing processes, regulatory oversight, technologies, and methods used.+ Ability to apply diagnostic medical experience and knowledge to business needs+ Excellent verbal and written communications. Proficient with evaluating and reporting complex scientific and clinical data and translating them into simple messages. Quick understanding of a disease landscape+ Must have proven experience working in a matrixed environment and be an effective collaborator+ Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues+ Comfortable executing on multiple projects independently+ Ability to build strong relationships with co-workers of various backgrounds and expertise+ Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor+ Excellent interpersonal skills, with the ability to gain respect and influence and to build lasting relationships with internal colleagues as well as external thought leaders within the diagnostics community+ Ability to critically review current Dx literature, providing relevance to our products and markets+ Planning and organizational ability as well as budget management+ Proficient in Microsoft Office suite and applications Strongly desired additional skills and experiences: + Experience with both anatomic and molecular pathology laboratories and test methods+ Experience and knowledge of IVD and CDx market, regulatory processes and reimbursement+ Prior direct management experience+ Experience interacting with pathologists and pathology laboratories_Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Medical Director level position could range from between $161,750 to $236,501 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 . This role requires up to 40% travel primarily to US offices but also with global travel for international business meetings several times per year._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 a home office._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 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_ loxoaccommodation@ _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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