Associate Director, Quality Assurance

Reports To:

Executive Director, QA

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, Quality Assurance is responsible for all aspects of Quality Assurance and GxP compliance. The Associate Director, Quality Assurance will establish and execute quality plans, policies and quality system elements related to GxP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system, batch record review/release, training program, CAPA/deviations, and perform internal and external audits at clinical sites and clinical and commercial suppliers. The Associate Director, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment and provide GxP guidance in Quality related areas. This position will report to the Executive Director, Quality Assurance.

Roles and Responsibilities of the Position*

Provide expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to assure GxP compliance.
Responsible for release and disposition of drug substance and drug product for clinical and commercial use.
Support the GxP vendor qualification and oversight process and be an SME in both areas of GCP and GMP.
Investigate product complaint system and interact with the contracted complaint vendor.
Conduct GxP compliance auditing program to fulfill regulatory requirements.
Support GMP/GCP risk profile process & mitigation through the Quality Planning Process.
Support product recall/market withdrawal process.
Support the management of pharmaceutical quality systems & continuous improvement.
Interact and develop relationships with vendors’ quality leaders through audits, project teams, and established one-on-one relationships.
Review and approve product specifications, GxP related deviations and CAPAs.
Write GxP Quality SOPs in support of Loxo Quality Systems.
Ensure compliance with corporate policies and procedures as well as US healthcare laws and regulations.
Support regulatory inspections of Sponsor, GCP sites and GxP vendors.
Provide reviews of regulatory dossiers (IND, IMPD, NDA, MAA, etc.).

Required Qualifications and Background

Minimum BS, Master’s degree or PhD with focus in Chemistry, Life Sciences, Engineering or similar technical field.
10+ years current work experience in pharmaceutical industry Quality Assurance required.
Expert knowledge of manufacturing, clinical, and analytical services employed in the pharma industry.
Solid and demonstrable knowledge of international GMP and GCP regulations and guidelines, industry practices, and experience implementing quality systems in a regulated environment; knowledge of GLP regulations.
Leadership in GxP vendor management and oversight.
Proven background in internal, vendor, and regulatory auditing and audit management.
Knowledge of risk management, mitigation, and controls.
Experience with complaint management.
Strong organization and time management skills.
Attention to detail with an ability to perform critical review of various types of documents.
Outstanding written and verbal skills.
Ability to travel to vendor sites (up to 25%).
Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
Strong written and oral communication skills.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Detail oriented and well organized.
Good and thoughtful listener.
Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office setting with up to 25% travel required.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Associate Director/Director Biomarker Operations

Location: South San Francisco, CA

Reports To:

Senior 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.

The Associate Director/Director Biomarker Operations will contribute to biomarker research and the development of diagnostic technologies for the Loxo Oncology drug pipeline by overseeing all patient sample collection, processing and analysis operations for Loxo’s clinical trials. The successful candidate will achieve this objective with the assistance of a biospecimen manager and in close collaboration with his/her Loxo clinical development colleagues, by directing activities at a network of external, contract labs.

Roles and Responsibilities of the Position*

The role is primarily focused on overseeing all clinical trial activities related to patient sample collection and processing, including (1) authoring select sections of clinical trial protocols, lab manuals and informed consent forms, (2) piloting and setting up central labs that process, store and analyze patient samples, and (3) validation of external labs providing reports utilized for enrollment purposes. The Operations lead also will oversee the existing biospecimen repository function, which includes sample inventory tracking, sample logistics and sample database maintenance. As time permits and depending on the individual, he/she may also contribute to the design and execution of clinical correlative studies and the team’s other research and diagnostic development projects.

Required Qualifications and Background

Masters or Ph.D. in a biological discipline.
At least 5 years of pharma and/or diagnostics industry experience, with a focus on translational medicine and/or operations.
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 several of the following:

Management of biorepository operations and databases.
Contracting, piloting and validating contract labs.
Management of teams at contract labs.
Writing of clinical trial protocols, lab manuals and consent forms.
Procedures for collecting and processing of clinical specimens.
Organization and coordination of multiple projects in parallel.
NGS and other high throughput genotyping technologies.
Extraction of DNA, RNA & proteins, particularly from FFPE samples.
RT-PCR and NGS assays of RNA abundance, CNVs and/or SNVs.
Extensive experience with Microsoft Office, particularly Excel
Well-developed program and project management execution, communication, and presentation skills.

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.

Associate Director/Director, Regulatory Affairs

Location: South San Francisco, CA

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.

Clinical Data Manager (Contractor)

Location: South San Francisco, CA or Stamford, CT

Reports To:

Senior 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 Contract Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials. This individual collaborates with the Clinical Trial Managers (CTMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.

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.

Clinical Research Associate

Location: Stamford, CT or South San Francisco, CA

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.

Clinical Scientist

Location: Stamford, CT or South San Francisco, CA

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.

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.

Clinical Trial Manager

Location: Stamford, CT or South San Francisco, CA

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*

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.

Cloud Systems Analyst

Location: Stamford, CT

Reports To:

Director, Information Technology

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 into the Director of IT, the Cloud Systems Analyst will be responsible for administering, supporting and training end users on Loxo’s various cloud-based applications.

Roles and Responsibilities of the Position*

Responsible for the daily operations and support of IT cloud-based applications.
Assume system ownership of key cloud-based systems including but not limited to SSO, Box, Zoom, accounting system, spend management system and DocuSign.
Communicates all changes, outages and any other cloud system impacts to Director of IT and end users.
Identifies areas for improvement by providing recommendations for more efficient IT/business processes within IT systems.
Ensures the provisioning of cost efficient information services and systems, while anticipating developments in fields of information technology.
Assures that controls, procedures and documentation are up to date and support ISO, SOX, GxP and FDA requirements for IT systems management.
Interface with strategic IT application and system vendors.
Partner with users of critical business applications to provide guidance and support.
Assist staff with hands-on systems management as required.
Assist Director of IT with the financial and SOX audit processes.
Act as system administrator and expert for multiple cloud-based applications.
Perform UAT testing as necessary for financial and GxP systems.
Ensures that all documents and other IP are stored in a highly secure environment.
Provide web-based, in-person and classroom training to disseminate features and best practices of cloud systems to end users as needed.
Partner with Director of IT and business owners with vendor and system selection processes.
Maintain strong partnerships with system vendors to ensure best value for the organization.

Required Qualifications and Background

At least 5 years of IT experience with a start-up, public and/or Biotech company.
Hands on experience in IT, including help desk and end-user onboarding.
Experience in system administration such as user management and basic system configuration.
Experience in SOX and/or GxP processes.
Experience with cloud-based enterprise IT systems (e.g., Box, DocuSign, Veeva, Okta, Intacct, NAV).
Experience following and providing feedback for SOPs and policies.
Experience conducting training to small or large groups, and creating associated training content.
Hands on experience with IT security, such as recommending and applying security settings to IT systems.
Demonstrated analytical skills and extremely high attention to detail.
Demonstrated strength in oral/written communication and interpersonal skills; team player.
Demonstrated organizational skills.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Good and thoughtful listener.
Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

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 approx. 10-15% travel as required.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Diagnostics Account Manager

Location: Detroit/Cincinnati

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*

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.

Diagnostics Account Manager

Location: Mid-Atlantic

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*

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.

Diagnostics Account Manager

Location: NY/New England

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*

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.

Diagnostics Account Manager

Location: South Central (Texas)

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*

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.

Diagnostics Account Manager

Location: Southeast (Atlanta/Nashville)

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*

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.

Diagnostics Account Manager

Location: Southwest (Phoenix/Las Vegas/Denver)

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*

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.

Director, Regulatory CMC

Location: South San Francisco, CA

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.

Manager, Quality Assurance GMP

Location: Stamford, CT or Boulder, CO or Remote

Reports To:

Executive Director, Quality Assurance

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.

Medicinal Chemist

Location: Boulder, CO

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.

Senior Accountant

Location: Stamford, CT

Reports To:

Accounting Manager

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 Senior Account will report to the Accounting Manager and will work directly with a wide range of individuals including senior management, finance team, vendors and other stakeholders. This individual must possess great attention to detail, meticulous organization skills, and a strong desire and ability to work within a dynamic, fast-paced environment with the expectations of the role consistently expanding.

Roles and Responsibilities of the Position*

The Senior Accountant will provide support across multiple areas in the department including: responsibility for improving accuracy and efficiency within our current policies and procedures, accounting for Clinical Trials, account analysis, contract reviews, improved continuation of SOX documentation and maintaining systems and procedures. Additionally, the Senior Accountant will support as needed: bank reconciliation, prepaid expenses, fixed assets, other account reconciliations, accrued expenses, contract administration and financial close responsibilities.

Required Qualifications and Background

4 - 8 Years of experience including recent Clinical Trial and R&D accounting experience Reporting experience
Strong analytical and accounting skills with thorough understanding of U.S. GAAP accounting principles and internal control
Ability to proactively identify and propose solutions to solve problems
Ability to work both independently and part of a team to perform multiple tasks simultaneously
Experience working in a SOX controlled environment
Strong Excel Skills
Cloud based ERP experience a plus

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.

Senior Manager, Compliance

Location: Stamford, CT

Reports To:

Head of Compliance

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 Senior Manager, Compliance will help build and establish the corporate compliance function to enhance the company’s strong culture of compliance. This individual will work collaboratively and strategically to drive a culture of ethics, integrity and compliance across the Loxo organization. In this role, you will have the opportunity to partner with all areas of the business, all levels of the organization and Loxo’s external partners.

This individual will assist in developing and implementing policies, procedures, compliance training and communications, auditing and monitoring, internal reporting, compliance-related investigations and other initiatives to continuously improve Loxo’s compliance program. This will include implementation of Loxo’s transparency & disclosure obligations, anti-bribery anti-corruption program, privacy and Global Data Protection Regulations (GDPR) reviews and other compliance projects and initiatives.

Roles and Responsibilities of the Position*

Work on various initiatives, including development of key compliance program elements, and across all areas of the business including research, development, medical affairs and commercial.
Draft compliance policies, SOPs, guidelines, and associated internal communications and training plans related to key areas of risk relevant to global pharmaceutical companies.
Design and deliver compliance-related training, including new hire training and policy related training for field-based and home office personnel.
Oversee implementation of the company’s state and federal aggregate spend reporting and disclosure obligations, including implementation of the appropriate systems, + policies and procedures.
Conduct compliance monitoring activities to prevent, monitor and detect compliance-related issues.
Provide compliance and policy guidance to business partners.
Perform or collaborate in performing investigations of potential compliance issues.
Assist with compliance programs such as anti-bribery anti-corruption/FCPA and privacy/GDPR compliance.
Assist with management of co-promotion obligations.
Maintain high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications and relevant training.

Required Qualifications and Background

Candidates should have strong academic credentials and 5-7 years of experience in compliance, preferably in a pharmaceutical or device company or in another health science industry or setting.
Knowledge of business and operations of pharmaceutical company, device manufacturer or related health industry.
Knowledge of relevant laws and regulations specific to health care industry including False Claims Act, Anti-Kickback Statute, FCPA, FDA rules on promotion, PhRMA and other industry codes.
Demonstrated experience in implementing some or all compliance program elements such as policies and procedures, compliance training, auditing and monitoring and investigations.
Strong verbal and written communication skills.
Ability to work well cross-functionally, across multiple areas of the business and at all levels.
Self-starter and able to work independently with minimal supervision.
Compliance business partner mindset to assist business in achieving goals in a compliant manner.
Good project management skills and can bring a project to completion in collaboration with multiple functional areas.
Articulate with good presentation skills and able to deliver training and clear compliance guidance.
Enthusiastic and passionate about the work that we do.
Ability to multi-task and handle multiple topics.
Detail oriented and well organized.

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 and may involve occasional traveling in the US to train field-based personnel.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Design Your Own Position

If you don’t fit into one of the above positions, tell us how you could contribute to the Loxo team and design your own position.

Position

Outstanding Team Member

Location

Stamford, CT, South San Francisco, CA, or Boulder, CO (or another location to be determined)

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.

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

If you share our passion, please let us know how you could contribute to our team. We don't want to pass up an opportunity for the right candidate to join us just because you found us before we found you.

Connect With Us

Submit your resume and your "Who", "What" and "Why" (see below) to careers@loxooncology.com.

Your "Who", "What" and "Why":

Who are you?
What will you bring to Loxo?
Why do we need you on the team?

Career Opportunities