Careers

Careers at Loxo


About Loxo Oncology: Loxo Oncology is dedicated to developing highly selective medicines for patients with genetically defined cancers. We base our approach on two scientific trends: the increasing use of genetic testing in cancer clinical medicine and improving chemistry approaches to building highly selective inhibitors against single targets in the cancer cell.  

Some people develop cancers that are caused by a single inappropriate DNA change, known as “oncogenic drivers.” When a genetic test identifies a patient with an oncogenic driver, there should be a personalized medicine to address this error in the DNA that is leading to the cancer. At Loxo Oncology, we are developing a pipeline of highly selective drugs that inhibit oncogenic drivers in cancer.

/Loxô/ is a term from Greek mythology that refers to the trajectory of an arrow, a fitting metaphor for our approach to developing precise, targeted therapies against genetically defined cancers.


Reports To:

AP Analyst

Overview of the Role:

Based in Stamford, CT, the A/P Coordinator position is full-time, temporary to permanent role that reports to the A/P Analyst. (S)he 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 & transferring invoices from invoice mailbox to cloud storage
  • Record invoices and credits into AP system module
  • Compare incoming invoicing against contracts and purchase orders to ensure accuracy
  • Respond to “RUSH” requests with a sense of urgency as needed
  • Review invoice calculations, timesheets, expenses, sales tax etc.
  • Ensure payments are made in a timely fashion
  • Identify and document NON-COMPLIANT invoices
  • Resolve invoice discrepancies directly with vendors & 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 & updating info and cleansing 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 process established
  • Ad hoc reporting and related projects, as requested

Qualifications and Background Required:

  • 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:

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

No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty 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


Location:

South San Francisco

Overview of the Role:

The Project Manager, Companion Diagnostics (CDx) will be responsible for supporting the Translational/CDx and CDx Regulatory Affairs group by providing project managementand regulatory submissions support for biomarker and diagnostic technologies for the Loxo Oncology pipeline. The successful candidate will be responsible for assisting the translational team in managing CDx partners and CROs developing diagnostic assays, coordinating transfer of materials and knowledge as well as collaborating with partners towards timely CDx regulatory submissions in a small fast-paced, dynamic work environment. In addition, he/she will assist in managing the development, outsourcing, and validation of clinically applicable biomarker assays. This function will play a critical role in R&D, with emphasis on later stage diagnostic development associated with Loxo’s oncology programs.

Key Responsibilities:

  • Provides project management and regulatory support on CDx project teams.
  • Supports the transfer of materials and knowledge between contract labs and CDx partners.
  • Tracks and reconciles clinical biomarker, CDx samples and data in collaboration with Loxo’s biospecimen manager.
  • Generates CDx team meeting schedules, agendas and meeting minutes.
  • Manages contracts, budgets and updates project Gantt charts and timelines.
  • Helps develop strategies to enable timely registration and approval of diagnostic products by regulatory agencies, synchronizing with the therapeutic development plan.
  • Handles interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks like regulatory pre-market approval (e.g. PMA, 510(k), IDE) submissions. 
  • Coordinates submission activities for devices including Significant Risk Determination (SRD) and Investigational Device Exemptions (IDEs), where necessary.
  • Coordinates review of key regulatory submissions to CDRH.
  • Supports Regulatory Lead and CDx Lead in interactions with FDA/CDRH and other health authorities (HA).
  • Coordinates responses to HA requests and applicable follow-up activities.
  • Works with document owners to track project deliverables and ensure on-time delivery.
  • Maintains knowledge of applicable regulatory requirements and scientific/technical issues relevant to assigned projects.
  • Works with regulatory team members to align all regulatory project activities and deliverables from each functional area.

Qualifications:

Position will be filled based on level of experience

  • B.S. degree or higher in a health-related field. Preferred: M.S., PharmD, or Ph.D.
  • Minimum of 7 years’ relevant project management experience in diagnostics at a diagnostics or pharma company.
  • Prior PMA experience in biotech or pharma.
  • Familiar with regulatory issues and challenges associated with drug/diagnostic co-development and companion diagnostics.
  • Well-developed program and project management execution, communication, and presentation skills.
  • High level of integrity, accuracy, and attention to detail.
  • 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.
  • Advanced knowledge and skill with MS Project, MS Excel and other reporting and tracking tools.
  • Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.
  • Outstanding interpersonal, communication and negotiation skills.
  • Demonstrated ability to guide/coach teams to timely achievement of objectives.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. It is expected that the successful candidate will spend ~15% of his/her time traveling on behalf of the company.

Work Environment:

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

No specific work demands.

* To perform this job successfully, an individual must be able to perform each essential duty 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:

Medical Affairs

Location:

South San Francisco, CA or Stamford, CT

Reports To:

Senior Director, Clinical Development and Medical Affairs

Position Description:

The Associate Director Medical Affairs manages the information and dissemination plan for all Loxo Oncology products. The Associate Director supports the efficient planning, tracking and dissemination of key data. This includes publications, abstracts, oral presentations, and seminars. The Associate Director provides expertise to a wide variety of communication-related projects and contributes significantly to continuing publication planning and execution, working with external authors, agencies and consultants. He/she establishes strong partnerships with medical thought leaders in the oncology area, oncology focused patient advocacy groups, and professional societies. He/she displays an understanding of the key role medical affairs plays in enhancing the safe and effective use of drugs and educating clinicians and patients regarding their use. Additionally, he/she will support the clinical and commercial vision and provide cross functional support. This individual will have strategic and operational responsibilities for all aspects of medical communications and publications.

Job Responsibilities (Key Responsibilities):

  • Develops, maintains, and delivers scientific communications strategy and plans and manages relationships with both internal and external groups.
  • Establishes strong partnership with medical thought leaders in the oncology field, patient advocacy groups, professional societies.
  • Reviews and approves manuscripts, abstracts, posters, slide presentations, and other documents to ensure appropriate evaluation and presentation of data, methodology, interpretation, and alliance with business objectives.
  • Develops content for and reviews slides for clarity, accuracy of content, and interpretation.
  • Gains a progressively deepening understanding of disease state and current medical and/or regulatory issues related to the Loxo Oncology portfolio, and serves as a technical resource on molecule and/or disease state; uses this expertise to interpret and present scientific and statistical data in publications.
  • Develops and execute an integrated, consistent medical communications and publications plan that supports clinical and commercialization strategies focusing on strategic communications and publications planning along the relevant events in the Targeted Genetic Therapy market.
  • Collaborates with the Preclinical, Clinical Development, Corporate Communications and Medical Affairs teams to translate data evidence into medical strategy and finally into medical communication objectives, key messages and activities.
  • Leads strategic planning and oversight of implementation of abstracts, posters, manuscripts, oral presentations for key meetings and gain input and agreement on the Congress Plans from cross-functional teams, including materials for booths, for advisory boards and for resources for Medical Science Liaisons.
  • Provides support and/or development of field based educational and promotional materials for scientific accuracy.

Educational and other Qualifications:

  • A medical or scientific degree (Pharm D, PhD, DO, MD, MS or RN) preferred with 5+ years of Medical Communications/Publications experience. Experience in the Oncology/targeted therapy drug market desired.
  • Excellent verbal and written communications. Proficient with evaluating and reporting complex scientific and clinical data and translating them into simple messages. Quick understanding of a disease landscape.
  • Must have proven experience working in a matrixed environment and be an effective collaborator either in the biotech/pharma industry or at a Medical Communication/Publications agency.
  • Strong knowledge of regulatory/compliance regarding promotion, Pharma guidelines and all other relevant industry standards.
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues.
  • Comfortable executing on multiple projects independently.
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Integrity
  • Flexibility
  • Experience with medical and scientific communication to expert and lay audiences
  • Experience with medical and scientific leaders in adult or pediatric oncology is desirable
  • Ability to combine medical experience and knowledge with commercial application
  • Excellent interpersonal skills, with the ability to gain respect and influence and to build lasting relationships with KOLs
  • Ability to critically review current literature, providing relevance to our products and markets
  • Experience in international medical environments a plus
  • Planning and organizational ability
  • Budget management Ability to travel (may include extensive overnight 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:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
  • No specific work demands.
  • To perform this job successfully, an individual must be able to perform each essential duty 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

Location:

Stamford, CT

Reports To:

Associate Director Clinical Operations

Position Description:

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.

Job Responsibilities (Key Responsibilities):

  • Responsible for the preparation and finalization of 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
  • Responsible for the selection of investigators and study sites
  • Responsible for identifying and responding 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
  • Responsible for the preparation of 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, and interact in a positive and professional manner
  • Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
  • Perform other duties as assigned

Job Qualifications:

  • 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
  • 25% travel required

Education and Skills:

  • BA/BS in related field
  • 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
  • Computer literate

Apply Now