Careers

Reports To:

Accounts Payable Supervisor

Position Summary

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 Accounts Payable (AP) Coordinator will ensure that invoices, purchase orders, payments, and other company expenses are processed accurately and timely, and that excellent relationships are maintained with our vendors and functional internal leads. 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 growing and expanding. The role will be responsible for but not limited to the items listed below.

Roles and Responsibilities of the Position*

• Responsible for reviewing and transferring invoices from invoice mailbox to cloud storage.
• Record invoices and credits into AP system module.
• Compares incoming invoicing against contracts and purchase orders to ensure accuracy.
• Respond to rush requests with a sense of urgency as needed.
• Reviews invoice calculations, timesheets, expenses, sales tax etc.
• Ensures payments are made in a timely fashion.
• Identify and document non-compliant invoices.
• Resolve invoice discrepancies directly with vendors and maintaining good vendor relations.
• Provide general ledger account coding for all invoices.
• Assist with 1099 process and vendor maintenance.
• Distribute invoices to approvers for payment authorization.
• Assist with current AP workflow and provide input to ensure process is increasingly efficient.
• Vendor maintenance support including adding and updating information and cleaning of data.
• Ensure W9 or W8BEN for is received for all vendors.
• Prepare weekly domestic international wires.
• Process weekly payment cycle.
• Maintain excellent communication and relationships with key stakeholders.
• Assist with quarterly accruals.
• Follow SOX internal controls and established processes.
• Ad hoc reporting and related projects, as requested.

Required Qualifications and Background

• 5+ years in accounts payable or relevant finance experience within a SOX controlled environment.
• Biotech, startup, or pharmaceutical experience a plus.
• Experience with any SaaS (cloud based) accounting systems a plus.
• Degree in accounting a plus.
• Experience and ability to work in fast-paced environment.
• Excellent interpersonal and communication skills (written and oral).
• Strong organizational skills with amazing attention to detail.
• Strong IT acumen with ability to work across multiple platforms and paperless AP environments.

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

TBD

Position Summary

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 seeks a driven, capable and adaptable Administrative Assistant who thrives in a fast-paced environment. This position plays an essential role in providing administrative support for our Stamford, CT office.

This position performs duties such as coordination of meetings, conferences, and travel, obtaining supplies, and working on special projects as needed. Other duties may include answering non-routine correspondence and assembling highly confidential and sensitive information. This position interacts with a diverse group of important external callers and visitors as well as internal contacts at all levels of the organization. Independent judgment is required to plan, prioritize and organize a diversified workload and recommend improvements in office practices or procedures.

The right candidate will have a keen attention to detail, excellent organizational and communication skills and an ability and willingness to help, no matter what the task!

Roles and Responsibilities of the Position*

• Must be able to work from 9am-5pm, Monday through Friday, on-site in our Stamford, CT office.
• Supports a team of dedicated professionals by performing key tasks as requested, proactively managing schedules and coordinating activities for maximum efficiency.
• Schedules and organizes complex activities such as meetings, travel, conferences and department activities.
• Acts as a substitute receptionist for company when needed, greeting outside visitors, answering the phone, fielding inquiries and assisting staff.
• Sorts and distributes mail.
• Answers phones as needed. Takes messages or fields/answers all routine and non-routine questions.
• Works both independently and within a team on a range of ongoing and on-off special projects. Acts as project manager for special projects, as needed, which may include: planning and coordinating multiple presentations and disseminating information.

Required Qualifications and Background

• B.A. degree preferred with at least 3+ years of administrative support. Pharmaceutical/biotech experience a plus.
• Professional demeanor and appearance and an excellent written and verbal communicator.
• Detail oriented and well organized.
• Able to work within a fast-paced environment adept at juggling multiple tasks and priorities.
• Good and thoughtful listener.
• Willing collaborator.
• 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 position are consistent with light office duties. May require some light lifting and moving of packages, office items, supplies and walking within the building to deliver packages/mail, show guests to meeting rooms etc..

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 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.

Apply Now

Reports To:

Senior Director, Clinical Development and Medical Affairs

Position Summary

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, Medical Affairs will assist in developing the medical strategy and plan for assigned product(s) as well as lead the execution of relevant medical affairs activities including advisory boards, medical education initiatives, congress activities, and payer interactions. Additionally, this individual will be tasked with maintaining a high level of scientific and medical expertise on the relevant disease areas and will also serve as a key medical resource in the disease area and on specific products.

Roles and Responsibilities of the Position*

• Provide medical expertise to the Commercial organization to compliantly assist in the development and execution of Commercial activities.
• Serve as medical affairs reviewer for promotional materials and non-promotional scientific materials.
• Forge strong relationships with key opinion leaders.
• Work with strategic alliances and partnerships as needed.
• Provide scientific and medical leadership as needed for publication planning and execution.
• Review Investigator Sponsored Study proposals.
• Provide support for Medical Science Liaison activities.
• Provide support as needed to Clinical Development and Clinical Operations to ensure successful execution of our clinical trials program.
• Support high-quality execution of corporate-wide initiatives.
• Exhibit leadership skills within and outside of the organization (including people skills, mentoring, presentation skills and professional interaction).

Required Qualifications and Background

• Minimum 6+ years in biotech/pharmaceutical industry with 3+ years in Medical Affairs.
• Advanced scientific degree. PharmD, PhD, MD degree highly preferred.
• Specialty training preferred; optimally in pediatric or adult oncology, diagnostics, or pathology.
• Experience working in oncology.
• Experience in working with strategic alliances and partnerships a plus.
• Proven leadership experience and able to work both independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities.
• Must be analytical and articulate in oral and written communications, with a demonstrated ability to communicate well with others at varying professional levels, especially in the medical profession.
• Track record of forming compliant partnerships with commercial colleagues.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
• Ability to think creatively and efficiently to define problems, collect data, establish facts and draw valid conclusions.
• Ability to travel domestically and internationally approximately 25%.

Physical Demands / Travel

The physical demands of this position are consistent with light office duties and also involves 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.

Work Environment

This position’s work environment is based in a typical office setting and also involves significant travel, including in vehicles, airplanes and other modes of transportation.

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.

Apply Now

Reports To:

Executive Director, Regulatory Affairs

Position Summary

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.

Roles and Responsibilities of the Position*

• Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
• Provide regulatory leadership and guidance to project teams
• Develop response strategies and submissions to regulators
• Develop briefing packages for meetings with FDA and other global health authorities
• Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial)
• Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
• Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
• Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
• Identify and assess regulatory risks for assigned projects or programs
• Prepare and deliver effective presentations for external and internal audiences
• Contact regulatory agencies relevant to assigned projects or programs, as appropriate
• Participate and contribute in Health Authority meetings as required

Required Qualifications and Background

• MS degree in life/health/technical sciences preferred
• Minimum 8+ years’ regulatory experience within the biotech or pharmaceutical industry within the drug development and approval process in INDs/NDAs
• Proven experience navigating successful submissions in the Oncology space is required; Preferences include recent successful NDA experience
• Knowledge and understanding of global regulatory requirements
• Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc. to attain group goals
• Demonstrate excellent communication skills
• Ability to represent the group in project teams
• Demonstrate strong organizational skills, including the ability to prioritize tasks
• Experience in interfacing with relevant regulatory authorities
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
• Experience in interpretation and application of regulations, guidelines, policy statements, etc.

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 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.

Apply Now

Reports To:

Sr. Manager, Clinical Data Management

Position Summary

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 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.

Roles and Responsibilities of the Position*

• Represents data management in study team meetings
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution)
• Executes and/or distributes data management metrics, listings, and reports, as required
• Oversight of data management CRO/service providers on assigned studies
• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables

Required Qualifications and Background

• Bachelor degree in Life Sciences, Computer Sciences, Mathematics, health related field or equivalent experience
• 6+ years of CDM experience in the pharmaceutical or biotechnology industry
• CRO management experience a plus
• Prior oncology/hematology experience highly desirable
• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
• Knowledge of industry standards (CDISC, SDTM, CDASH)
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Proven ability to work both independently or in a team setting

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Department:

Clinical Operations

Reports To:

Associate Director or Director, Clinical Operations

Position Summary

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.

Roles and Responsibilities of the Position*

Project Management:

• Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
• Use performance metrics and quality indicators to assist the Clinical Trial Manager in driving study execution.
• Participate in monitoring visit report review process to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
• Support Health Authority inspections and CQA audits as required.
• Ensure full compliance (completeness and accuracy) of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Provide proactive identification of potential risks and develop and implement actions to avoid or mitigate.
• Develop and maintain collaborative relationships with internal and external partners/stakeholders.

Study Planning and Conduct:

• Collaborate with vendors and Loxo CTM’s regarding study specific issues and follow through to resolution.
• Assist in the creation and review of study documents, including but not limited to the Protocol, Protocol Synopsis, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed.
• Participate in vendor specification development and management/oversight.
• Assist with management of TMF set-up, ongoing quality review, and final reconciliation.
• Assist with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
• Actively contribute to study meetings including presenting as a subject matter expert, generating, finalizing and distributing study team agendas and recording meeting minutes as needed.
• Contribute to development/coordination of study training and study training materials for study team, investigational sites, and vendors.
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
• Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
• Assist with investigator meeting coordination and planning.

Required Qualifications and Background

• Degree in a relevant discipline with experience in the Clinical Trial environment required.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Demonstrates analytical approach and anticipation of problems.
• Identifies gaps and provides constructive feedback and solutions.
• Ability to multi-task effectively and prioritize assignments from multiple sources.
• Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments.
• Knowledge of study tools including electronic system skills such as CTMS / EDC/ IRT/eTMF.
• Knowledge of drug development process.
• Proactively shares information, ideas, input, and/or expertise with team members.
• Demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looks for ways to contribute.
• Basic understanding of project management desired.
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
• Strong oral and written skills with proficiency in English.
• Excellent organizational skills

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Senior Director, Clinical Development & Medical Affairs

Position Summary

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.

Roles and Responsibilities of the Position*

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.

• Serve as the clinical science representative on global and regional clinical execution teams.
• Creates and fosters 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, implementation, operations/study management and interpretation of clinical trials.
• Lead the writing of protocols, informed consent forms, clinical study reports and regulatory-related documents.
• Work closely and liaise regularly with clinical sites and investigators to ensure implementation of clinical studies.
• 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 be accountable for study start up activities, site initiation visits, interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.
• Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget and time-constraints, in partnership with CROs and Loxo regional and in-country groups, to deliver submission-quality data.
• Demonstrate efficiencies in the areas of budget management, contracting and resourcing.
• Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
• Work with external experts to develop abstracts, manuscripts, study/program design and presentations.
• 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 act 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 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.
• Travel up to 20%, may include international travel

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.

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Department:

Clinical Operations and Project Management

Reports To:

Director Clinical Operations

Position Summary

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.

Roles and Responsibilities of the Position*

• Prepare and finalize project and study- related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required.
• Select investigators and study sites.
• Identify and respond to site and study related issues and recommending corrective actions and/or escalating to supervisor.
• Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT.
• Ensure that CRF data queries are resolved.
• Coordinate and manage Investigational Product including overall accountability and reconciliation.
• Prepare study budgets and timelines.
• Manage project timelines and vendor performance to meet departmental and corporate goals.
• Manage study budget and payment process for all clinical trial vendors including investigative sites.
• Monitor and track clinical trial progress and provide status update reports.
• Manage all clinical trial vendors (e.g., IVRS, central labs, and IRB).
• Responsible for selection of CRO study staff and coordinating training including documentation.
• Hire, train and oversee study field monitors (e.g., review of all trip reports) and provide guidance on site issues.
• Lead with minimal supervision in the planning of investigator meetings and making presentations, as required.
• Lead the review of clinical data at the CRF, data listing, and report table levels.
• Represent Clinical Operations at the project team level for individual studies, as appropriate.
• Partner with other research and development groups to achieve deliverables.
• Participate in Site Initiation Visits (SIVs) as required.
• Co-monitoring of regional sites for adherence to protocol and GCP as required.
• Travel as required to carry out responsibilities.
• Identify and escalate site, vendor and study related issues to supervisor, as appropriate.
• Participate in clinical and department settings, including attending additional meetings as required, interacting in a positive and professional manner.
• Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals.
• Perform other duties as assigned.

Required Qualifications and Background

• BA/BS in related field.
• Minimum 8 years clinical drug development experience.
• Experience in personnel management.
• Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
• Experience in managing oncology clinical trials (international preferred).
• Knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
• Ability to work within a team, including leadership skills.
• Ability to organize and prioritize multiple tasks.
• Excellent communication and interpersonal skills.
• Attention to detail, organization, and problem-solving skills.
• Proficient in MS Office.

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Diagnostics Account National Lead

Position Summary

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.

Roles and Responsibilities of the Position*

• As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
• Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
• Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
• Target, develop, assess and maintain a thorough understanding of accounts and key customers
• Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
• Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
• Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
• Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
• Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
• Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
• Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events
• Develop and implement educational speaker programs for the pathology/lab audience
• Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
• Develop and maintain all account/contact details within Customer Relationship Management database
• Utilize data analytics and tracking tools to effectively monitor and direct customer activities
• Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

• BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
• Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
• 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
• Proven relationships with oncologists and/or pathologists
• Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
• Strategic account management experience, including developing & implementing attainable account-specific business plans
• Excellent listening, time management, organizational and interpersonal skills
• Must possess strong analytical, negotiation and customer relations skills
• Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
• Excited about an early stage company environment that may require greater self-sufficiency
• Proficient in Microsoft Office suite and applications
• Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Position Summary

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 to the Vice President, Commercial, the Director, Field Operations will build a best-in-class biotech operations function to support the launch of several exciting new oncology drugs. The Director, Field Operations will be responsible for a wide variety of projects across the Commercial and Medical organizations to include functioning as the Loxo lead for operational implementation of field facing systems and incentive compensation, in coordination with a co-promote partner and its field operations team.

Roles and Responsibilities of the Position*

• Responsible for all services and the infrastructure needed to proactively support Sales, Marketing, Reimbursement, and Medical Affairs
• Leveraging co-promote partner systems/infrastructure as appropriate, build out and oversee Loxo operations function to enable the work of field colleagues and ensure timely and accurate collection, analysis, and reporting of data
• Build and maintain strong rapport with sales management and other key customers to ensure ongoing support needs are met
• In coordination with co-promote partner, implement medical and sales field force sizing and deployment strategies to ensure larotrectinib launch and Loxo portfolio objectives are appropriately achieved
• Leveraging co-promote partner systems as appropriate, sponsor CRM / field automation and decision support system implementation and upgrades. This includes identifying business requirements and approving design elements, user acceptance testing, and training. Identify and partner with third-party service providers for appropriate functions
• Maintain appropriate vehicle selectors for field personnel and ensure cost effective operation of fleet
• In coordination with co-promote partner, facilitate the design and ongoing administration of incentive compensation plans for field colleagues. Ensure plans compliantly motivate field personnel and effectively support objectives for marketed and pipeline products
• Leveraging co-promote partner systems as appropriate, implement effective customer targeting and reporting tools to support on-going sales promotion and assist management in evaluating sales productivity/performance
• Ensure sampling policies and practices comply with all laws and regulations
• Manage department budget and perform annual business planning
• Manage other Operations responsibilities including:
  • Planning and logistics for sales meetings / POAs
  • Field force communications and inquiry management
  • Review committee process management (using Veeva PromoMats or other system)
  • Meetings and conventions logistics management (i.e. securing space, booth development, vendor to management)
  • Production, inventory management, and fulfilment/shipping of sales & marketing materials
  • Speakers bureau development, and management
  • HCP engagement contracting / compliance champion
• Co-lead operational design and implementation of field metrics to support Medical Affairs, Medical Science Liaisons, and National Account Directors
• Work collaboratively with co-promote partner and Analytics team to develop tools and dashboards that capture key performance metrics
• Monitor the organization’s compliance with required standards for maintaining CRM data
• In coordination with co-promote partner, ensure timely and accurate collection, analysis, management and dissemination of all field sales report
• Responsible for submitting and maintaining compliance reporting (Sunshine Act, etc.)

Required Qualifications and Background

• Bachelor’s Degree in Business/Marketing, Accounting, Computer Science or related field—MBA preferred
• Minimum of seven years of biotech/pharmaceutical operations management experience, including sales operations
• Experience establishing the infrastructure needed to ensure readiness for a first commercial drug launch
• Strong knowledge of pharmaceutical sales data and systems including Veeva CRM
• Experience with the launch of new sales organizations and products and the development and implementation of field force deployment strategies
• Extensive experience with the development and implementation of national incentive compensation plans
• Skilled at communicating complex concepts to senior leaders/field colleagues
• Strong analytical skills with the capability to appropriately define issues, questions and data needs
• Experience managing third-party providers
• Demonstrated skills in interdependent team leadership. Highly developed decision-making and leadership skills
• Proven ability to direct multiple projects effectively
• Proficient with Microsoft Office
• 20% travel required

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position is required to travel approximately 20%.

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 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.

Apply Now

Reports To:

Executive Director, Regulatory Affairs

Position Summary

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.

Roles and Responsibilities of the Position*

• Responsible for aiding in the coordination, authorship, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submission and marketing applications to FDA and international regulatory authorities), which support clinical programs, CMC and quality.
• Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
• Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.

Required Qualifications and Background

• Ph.D. or a Master’s degree with 10+ years pharmaceutical industry experience and a minimum of 8 years in Regulatory Affairs.
• Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
• Established working knowledge of regulatory guidelines and regulations (US and international).
• Regulatory experience supporting both development projects and commercial products.
• Strong knowledge of eCTD elements and structure and regulatory writing skills.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• 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 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 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.

Work Environment

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.

Apply Now

Position Summary

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 Director/Senior Director, Drug Safety will be responsible for establishing and managing the internal safety surveillance program for investigational and post marketed products. Additionally, the Director/Senior Director, Drug Safety is responsible for managing technical functions while working in conjunction with with the clinical team and senior leadership to shape cohesive pharmacovigilance strategies through effective optimization and integration of operational and safety systems functions. This individual will be responsible for the structural, technical and managerial organization within the Drug Safety Department.

Roles and Responsibilities of the Position*

• Ensures standard processes and procedures for all aspects of pharmacovigilance including Adverse Event case handling, aggregate reporting is handled to assure compliance with global and local regulatory requirements.
• Demonstrates advanced knowledge of safety concepts, per ICH, US and international guidelines and Good Pharmacovigilance Practice (GPvP).
• Collaborates with safety systems associates ensuring Argus support of safety reporting, audits and inspections, aggregate reports, and signal detection.
• Management of external safety operation vendors.
• In partnership with the clinical leads, plan and execute safety review meetings.
• Collaborate with internal and external stakeholders, including: Medical Affairs, Clinical, Regulatory, Quality Assurance, Marketing Partners, and CROs for all safety related tasks.
• Responsible for the oversight of SOPs and the development and management of plans/procedures needed for the Safety Group to execute its responsibilities.
• Provides expert pharmacovigilance guidance and leadership both internally and externally.
• Responsible for oversight of quality, standards and training of personnel.
• Responds appropriately to rapidly changing safety regulatory environment with minimal oversight.
• Responsible for the oversight of regulatory queries concerning adverse event documentation.

Required Qualifications and Background

• Clinical experience as a, Pharm.D., Ph.D., MSN, BSN. with direct industry experience is required including significant safety surveillance with clinical expertise/experience in Oncology.
• Minimum of seven to ten years of progressive experience in Drug Safety in a biotechnology or pharmaceutical company required.
• Current Oncology experience required.
• Prior experience in regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance required.
• Advanced knowledge of safety concepts, per ICH, US and international guidelines and Good Pharmacovigilance Practice (GPvP) required.
• Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
• Expertise in the use of MedDRA is required.
• Strong operational skills as demonstrated by leading previous projects or functions and or equivalent in training and education in areas such as Lean Six Sigma or MBA preferred.
• Must possess strong ability to communicate and integrate their work activities with co-workers, and to effectively organize and present ideas and results.
• Must be proficient in MS Office Suite.
• Expert knowledge of relational database applications (including Argus or other safety database).
• Solid knowledge of safely database operations and functions.
• Strong ability to prioritize tasks and keen attention to detail.
• Excellent writing, communication, presentation, and interpersonal skills.
• Demonstrated leadership and project management skills.
• Ability to be both enterprising and resourceful.
• Proven ability to work on multiple projects in a fast-paced environment.
• Ability to travel domestically and internationally approximately 25%.

Supervisory Responsibilities:

• This position supervises Operational and Safety Systems Personnel in the Drug Safety Department.

Physical Demands / Travel

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.

Work Environment

This position’s work environment is based in a typical office setting with some domestic and international 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.

Apply Now

Position Summary

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 position will be responsible for managing IT projects in support of Loxo Commercial Operations in a technology role deploying CRM and other commercial IT systems. This individual will assist with the planning and implementation of Veeva CRM and will be responsible for high quality data analysis and configuration deliverables. Additionally, this individual will have the ability to troubleshoot systems issues and connections as well as possess the aptitude to resolve issues working in tandem with business owners.

Roles and Responsibilities of the Position*

• The IT Project Manager will oversee project planning and execution of Veeva system implementation, including CRM and Medical modules from user adoption through training as well as general administration function for accuracy and completeness.
• Act as Commercial IT Systems SME and have oversight of process analysis, data profiling, data mappings, application configuration, solution testing, and documentation.
• Responsible for the daily IT operations of the Veeva CRM platform and support as needed.
• Interface and maintain relationships with strategic IT vendors on business-critical applications and infrastructure to ensure smooth implementation as well as best value for the organization.
• Assure that controls, procedures and documentation are up to date and support ISO, SOX and FDA requirements for IT systems management.
• Partner with Commercial users as needed regarding critical business applications to provide guidance and support.
• Review legal contracts pertaining to IT systems.

Required Qualifications and Background

• Minimum of 3-5 years’ experience supporting commercial organizations in a technology role deploying MDM, CRM, or similar projects.
• Hands-on experience with master data management, system integration, and/or data management process analysis.
• Minimum of 2-4 years’ experience working with cloud based systems in a configuration or administration role.
• Experience working as an administrator for a Veeva Platform strongly preferred.
• Ensures that all documents and other IP are stored in a highly secure environment.
• Perform QA validation processes for change management and risk assessment of systems.
• 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.
• Must be open to travel 10-15%.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. Travel may be required up to 10-15%, US and 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.

Work Environment

This position’s work environment is in an office with some light travel for conferences and business meetings.

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.

Apply Now

Position Summary

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.

Roles and Responsibilities of the Position*

• Ensure GxP work at Loxo is done in compliance with applicable regulations and guidelines.
• Provide quality and compliance oversight of the quality systems at Loxo and those of contract manufacturing, testing, research and/or laboratory organizations including, but not limited to: product complaints, deviations, OOS investigations, document creation and control, site audits, change control, validation (e.g. process, cleaning, analytical method, etc.), stability, batch record review, and product disposition.
• Participate in the review, evaluation and approval of contract manufacturing, testing, research and/or laboratory facilities.
• Manage controlled documents and systems.
• Manage employee training
• Review and approve GxP related documents as requested and appropriate.
• Participate on project teams and sub-teams as needed and assigned.
• Track progress versus timelines and goals.
• Ensure documents and records are kept in compliance with regulations and SOPs.

Required Qualifications and Background

• BA/BS and a minimum of 7- 10 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
• Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines.
• Experience with implementing and maintaining pharmaceutical quality systems.
• Experience writing and presenting clearly on quality topics.
• Prefer experience in oversight of outside vendors and contractors.
• Ability to work in a virtual manufacturing environment.
• Personal flexibility and a desire to lead, learn and achieve in a collaborative environment.
• Ability to travel for both domestic and international business.
• Strong understanding of GxP requirements for Phase I through commercial stage in small molecules and CMC manufacturing.

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Executive Director, Drug Discovery

Position Summary

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.

Roles and Responsibilities of the Position*

• Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
• Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME and PK by coupling multivariant SAR analysis with hypothesis driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
• Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
• Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, tactics, purification and characterization techniques.
• Synergize with the broader team by communicating results, sharing insights, making plans and setting goals in an open, honest way.
• Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
• Implement and maintain the necessary equipment, processes, software and infrastructure to enable a state of the art medicinal chemistry facility.
• Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.

Required Qualifications and Background

• B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
• 5-15+ years of experience in small molecule drug discovery experience in biotechnology or pharmaceutical setting.
• Proven track record of success in advancing programs from leads to advanced candidates.
• Extensive experience lead compound optimization in the areas or potency, selectivity, ADME and PK.
• Highly versed the all current medicinal chemistry instrumentation: HPLC, LC-MS, NMR and purification systems.
• Expert in using common medicinal chemistry software: electronic notebook, structure drawing, data spreadsheet analysis; data visualization; structure viewing; literature, chemical and database searching.
• Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences.
• An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management and multi-tasking skills.

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Director, Biostatistics

Position Summary

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 Principal Statistical Analyst is responsible for the planning and tracking of statistical programming activities to ensure efficient use of resources. Project-level responsibilities include oversight and management of workflow in generation of study-specific and ad-hoc clinical data listings, summary tables and figures. The core duties and responsibilities of the Principal Statistical Analyst are listed below.

Roles and Responsibilities of the Position*

• Perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• Create and review CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
• Perform data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Review Data Management Plan, Data Validation Plan and edit check specifications.
• Interact with statisticians and other clinical team members, perform ad hoc analysis and generate outputs according to the requirements.
• Implement and contribute to statistical analysis plans; provide additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
• Recognize inconsistencies and initiate resolution of data problems.
• Act independently to determine methods and procedures on new assignments.
• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.

Required Qualifications and Background

• Experience in the analysis of complex oncology clinical trial data.
• Experience in managing multiple projects.
• Solid knowledge of SAS Programming language.
• Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
• Experience working with Oncology trials and NDA submission experience is highly desirable.
• Bachelor/Master degree in Statistics, Life Sciences, Computer Sciences, or Mathematics with a minimum 5-8 years Pharmaceutical/Biotech programming experience.
• Proven ability to work both independently and in a team setting.
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
• Excellent verbal/written and interpersonal skills.
• Ability to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
• Ability to work effectively in a fast-paced environment with a positive “can-do” proactive attitude.

Physical Demands / Travel

This position will travel occasionally 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.

Work Environment

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.

Apply Now

Reports To:

Associate Director, Translational Medicine

Position Summary

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.

With a background in cancer biology, the Scientist/Senior Scientist, Translational Medicine will lead and support translational research projects associated with Loxo’s preclinical and early development programs.

Roles and Responsibilities of the Position*

The successful candidate will formulate and execute plans aimed at characterizing our lead compounds, including their: (1) efficacy (in vitro and in vivo), (2) mechanism of action, (3) target patient populations, and (4) biomarkers predicting clinical response. Responsibilities may also involve developing prototype clinical diagnostic tests for promising biomarkers. The Scientist/Senior Scientist, Translational Medicine will achieve these objectives by collaborating with Loxo’s discovery scientists, extending existing collaborations with academic institutes, identifying and overseeing research at CROs and working closely with clinical development colleagues at Loxo.

Required Qualifications and Background

• Ph.D. in a biological discipline with at least 8 years of bench experience.
• Research experience in oncology, preferably with some exposure to heme-oncology and/or immuno-oncology.
• Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
• Willingness to work collaboratively and incorporate diverse perspectives into decision-making.
• Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.

The ideal candidate will have experience with many of the following:

• Design and execution of cancer cell line and xenograft studies assessing compound efficacy.
• Engineering of knock-in & knockdown cell lines with CRISPR and/or other technologies.
• High throughput siRNA and/or CRISPR screens of cell lines.
• Extraction of DNA, RNA & proteins, particularly from FFPE samples.
• RT-PCR and NGS assays of RNA abundance, CNVs and/or SNVs.
• IHC, Western blot, ELISA and mass spectrometry assays of protein abundance.
• FISH assays of chromosomal abnormalities.
• Animal models used for immune-oncology, inflammation, or autoimmunity research.
• Immunology/auto-immunity assays, including immune cell isolation and characterization using flow cytometry.
• Design and execution of cross-assay validation studies.
• Management of internal and/or CRO-based bench scientists.
• Management of academic sponsored research.
• Organization and coordination of multiple projects in parallel.
• Preparing and presenting scientific results at congresses and in peer-reviewed journals.

Physical Demands / Travel

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.

Work Environment

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.

Apply Now

Reports To:

Executive Director, Discovery Biology

Position Summary

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.

At Loxo we seek dedicated, passionate, hardworking individuals who thrive within a collaborative and fast-paced environment. We are looking for knowledgeable, thoughtful professionals to bring their experiences, unique perspectives and problem-solving skills to the team.

The Senior Bioassay Scientist will be responsible for identifying, developing and performing robust, reproducible biological assays to support drug discovery and development in a team environment. The Senior Bioassay Scientist will design, execute, and trouble-shoot experiments, perform comprehensive data analysis, communicate experimental findings to team members, identify, manage, and oversee work projects with CROs, support regulatory filings, and be actively engaged in advancing drug discovery programs. In addition, the Senior Assay Scientist will be instrumental in setting up the lab and maintaining lab equipment. This is a “hands-on” laboratory based position.

Roles and Responsibilities of the Position*

The Senior Bioassay Scientist must have experience:

• Performing a wide range of bioassays and immunoassays to determine dose response
• Designing, initiating, optimizing, and executing medium throughput plate-based cell-based assays
• Analyzing and managing the data from complex experiments and applying basic statistical analysis
• Configuring and troubleshooting laboratory automation

The Senior Bioassay Scientist will be responsible for:

• Designing, executing a trouble-shooting experiences
• Performing comprehensive data analysis and communicating findings to team members
• Identify, manage and oversee work projects with CROs
• Supporting regulatory filings
• Being actively engaged in the drug development process
• Setting up and managing the lab and maintaining the lab equipment

Required Qualifications and Background

• BA/BS/MS in biology, biochemistry or related field
• Minimum of 8 years of highly relevant hands-on lab experience in biotech or pharma environment
• Excellent oral and written communication skills including experimental documentation
• Works well with team members daily across functional areas
• Continual learner
• Ability to supervise and mentor
• Works independently with a can-do attitude

Physical Demands / Travel

The physical demands of this job are consistent with working within a laboratory setting conducting experiments and handling lab equipment. Moderate lifting, movement around the laboratory and the operation of lab equipment is 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.

Work Environment

This position’s work environment is in a laboratory.

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.

Apply Now