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.


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.

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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

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