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.
Executive Director, QA
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Associate Director, Quality Assurance is responsible for all aspects of Quality Assurance and GxP compliance. The Associate Director, Quality Assurance will establish and execute quality plans, policies and quality system elements related to GxP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system, batch record review/release, training program, CAPA/deviations, and perform internal and external audits at clinical sites and clinical and commercial suppliers. The Associate Director, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment and provide GxP guidance in Quality related areas. This position will report to the Executive Director, Quality Assurance.
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.
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 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 roles 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.
Senior Director, Translational Medicine
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Associate Director/Director Biomarker Operations will contribute to biomarker research and the development of diagnostic technologies for the Loxo Oncology drug pipeline by overseeing all patient sample collection, processing and analysis operations for Loxo’s clinical trials. The successful candidate will achieve this objective with the assistance of a biospecimen manager and in close collaboration with his/her Loxo clinical development colleagues, by directing activities at a network of external, contract labs.
The role is primarily focused on overseeing all clinical trial activities related to patient sample collection and processing, including (1) authoring select sections of clinical trial protocols, lab manuals and informed consent forms, (2) piloting and setting up central labs that process, store and analyze patient samples, and (3) validation of external labs providing reports utilized for enrollment purposes. The Operations lead also will oversee the existing biospecimen repository function, which includes sample inventory tracking, sample logistics and sample database maintenance. As time permits and depending on the individual, he/she may also contribute to the design and execution of clinical correlative studies and the team’s other research and diagnostic development projects.
The ideal candidate will have experience with several of the following:
It is expected that the successful candidate will spend 15% of his/her time traveling on behalf of the company.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is based 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 roles 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.
Executive Director, Regulatory Affairs
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Associate Director/Director, Regulatory Affairs will contribute to the formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as the regulatory contact for US/Global health authorities as required. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing book for FDA meetings, as well as responses to requests.
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.
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 roles 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.
Senior Manager, Clinical Data Management
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Contract Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials. This individual collaborates with the Clinical Trial Managers (CTMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.
This position will travel occasionally; the average travel for this position is 10-15% with some variation based upon the demands of the business imperatives.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The position’s work environment is based in a typical office setting with occasional travel required.
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 roles 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.
Clinical Operations
Associate Director or Director, Clinical Operations
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Clinical Research Associate, in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
Project Management:
Study Planning and Conduct:
This position may require up to 25% travel. Some of the travel may be international.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is based in the field and in a typical office setting.
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 roles 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.
Senior Director, Clinical Development & Medical Affairs
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
This position offers the opportunity to participate in the entire spectrum of the drug development process. Loxo designs drugs “from the ground up” by selecting a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. This role is integral in moving 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. The Clinical Scientist will participate directly in improving the lives of people fighting their cancers.
In tandem with the Medical Director this role designs, implements and executes Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as the position interacts with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.
Loxo is a small company highly focused on clinical and regulatory execution. As a key member of the team, the Clinical Scientist 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 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 individual must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.
In summary, qualities sought include: intrinsic motivation, excellent communication and organizational skills; a passion for biomedicine and for patients; broad prior experience in drug development; and a comfort and desire to learn new skills.
This position requires approximately 20% travel, which will fluctuate as business imperatives change.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is based in the field, occasionally in a lab and within a typical office setting.
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 roles 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.
Clinical Operations and Project Management
Director Clinical Operations
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Clinical Trial Manager functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.
This position requires approximately 25% domestic and international 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.
This position’s work environment is based in a typical field and office setting.
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 roles 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.
Director, Information Technology
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
Reporting into the Director of IT, the Cloud Systems Administrator will be responsible for administering, supporting and training end users on Loxo’s various cloud-based applications.
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.
This position’s work environment is in an office with approx. 10-15% travel as required.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Diagnostics Account National Lead
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.
Please note this role will require 70-80% US travel, primarily within assigned region but also nationally as required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is remote based, with significant travel on a regional basis to various sites.
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 roles 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.
Executive Director, Regulatory Affairs
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
Responsible for leading the CMC regulatory function, the Director, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing of regulatory CMC submissions and manage the interactions with all Health Authorities for CMC topics. This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
The physical demands of this position are consistent with light office duties. This position may require occasional 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.
This position’s work environment is based 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 roles 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.
Executive Director, Quality Assurance
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Manager of Quality Assurance provides quality and compliance oversight of contract manufacturing, testing, research and/or laboratory organizations. This position reports to the Executive Director of Quality Assurance with a preference in Boulder, CO or Stamford, CT or can be remotely based.
The physical demands of this job are consistent with light office duties. This position requires domestic and international travel up to 25%.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is in an office and requires travel both international and domestic to meetings, conferences etc.
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 roles 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.
Executive Director, Drug Discovery
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
Loxo Oncology’s newly formed Drug Discovery group in Boulder, Colorado has an immediate opening for an experienced medicinal chemist. The Loxo Drug Discovery group’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we are building a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for an accomplished Medicinal Chemist with a proven track record of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to solve medicinal chemistry challenges and excel at working closely with scientists across disciplines. The position requires excellent people skills, a positive can-do attitude and the ability to thrive in a highly interactive, fast-paced, team environment.
The physical demands of this position are consistent with working in a laboratory/ bench environment. Some light lifting and maneuvering may be required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is based in a laboratory/ bench environment.
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 roles 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.
Accounting Manager
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
Based in Stamford, CT, the Senior Account will report to the Accounting Manager and will work directly with a wide range of individuals including senior management, finance team, vendors and other stakeholders. This individual must possess great attention to detail, meticulous organization skills, and a strong desire and ability to work within a dynamic, fast-paced environment with the expectations of the role consistently expanding.
The Senior Accountant will provide support across multiple areas in the department including: responsibility for improving accuracy and efficiency within our current policies and procedures, accounting for Clinical Trials, account analysis, contract reviews, improved continuation of SOX documentation and maintaining systems and procedures. Additionally, the Senior Accountant will support as needed: bank reconciliation, prepaid expenses, fixed assets, other account reconciliations, accrued expenses, contract administration and financial close responsibilities.
The physical demands of this position 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.
This position’s work environment is based in a typical office setting.
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 roles 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.
Head of Compliance
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Senior Manager, Compliance will help build and establish the corporate compliance function to enhance the company’s strong culture of compliance. This individual will work collaboratively and strategically to drive a culture of ethics, integrity and compliance across the Loxo organization. In this role, you will have the opportunity to partner with all areas of the business, all levels of the organization and Loxo’s external partners.
This individual will assist in developing and implementing policies, procedures, compliance training and communications, auditing and monitoring, internal reporting, compliance-related investigations and other initiatives to continuously improve Loxo’s compliance program. This will include implementation of Loxo’s transparency & disclosure obligations, anti-bribery anti-corruption program, privacy and Global Data Protection Regulations (GDPR) reviews and other compliance projects and initiatives.
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.
This position’s work environment is in an office and may involve occasional traveling in the US to train field-based personnel.
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 roles 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.
Outstanding Team Member
Stamford, CT, South San Francisco, CA, or Boulder, CO (or another location to be determined)
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. 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 field of medicine and for individual patients.
If you share our passion, please let us know how you could contribute to our team. We don't want to pass up an opportunity for the right candidate to join us just because you found us before we found you.
Submit your resume and your "Who", "What" and "Why" (see below) to careers@loxooncology.com.
Your "Who", "What" and "Why":