Careers

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Location:

Stamford, CT and South San Francisco, CA

Reports To:

Senior Director-Clinical Development & Medical Affairs

Opportunities:

This position offers the opportunity to participate in the entire spectrum of the drug development process. We design our drugs “from the ground up”, starting with the selection of a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target.  In your role, you will have the opportunity to move 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. You will participate directly in improving the lives of people fighting their cancers.

Overview of the Role:

In your role, you team with the medical director to design, implement and execute Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as you will interact with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders. 

We are a small company, but we are highly focused on clinical and regulatory execution. As a key member of our team, you 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 person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.

*Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Serve as the clinical science representative on global and regional clinical execution teams.
• Create and foster strong strategic partnerships with colleagues that include Clinical Operations/Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management and pre-Clinical Development. 
• Lead the design, implementation, operations/study management, and interpretation of clinical trials. 
• Lead the writing of protocols, informed consent forms, clinical study reports and regulatory-related documents.
• Work closely and liaise regularly with clinical sites and investigators to ensure implementation of clinical studies.
• Review, interpret, and present clinical data from development program and the relevant literature at relevant scientific meetings. 
• Support the writing of subsequent regulatory briefing documents.
• Lead and accountable for study start up activities, site initiation visits, interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings. 
• Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget and time-constraints, in partnership with CROs and Loxo regional and in-country groups, to deliver submission-quality data.
• Demonstrate efficiencies in the areas of budget management, contracting and resourcing.
• Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
• Work with external experts to develop abstracts, manuscripts, study/program design and presentations.
• Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
• Proactively generate ideas for improvements and take action to solve problems and achieve goals beyond what is required.
• Supervisory Responsibilities: None

Qualifications/Qualities:

• Require 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 along 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 we are looking for 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.

Certificates, Licenses, Registrations:

Computer Skills:

• Must be proficient in MS Office Suite.

Other Skills and Abilities:

Must have excellent verbal, written and communication skills.

• Ability to work independently as well as in a team environment.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment.
• Demonstrated ability to stay abreast of trends and new information in the profession.
• Demonstrated leadership and project management skills.

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.

This position will travel occasionally; the average travel for this position is 20% with some variation based upon the demands of the business imperatives.

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

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Department:

Quality Assurance

Reports To:

Head of Quality Assurance

Summary:

The Director of Quality Assurance provides quality and compliance oversight of the quality systems at Loxo and those of contract manufacturing, testing, research and/or laboratory organizations. This position reports to the VP of Business Operations and Program Management and can be remotely based.  

Responsibilities:

• 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.

Requirements:

BA/BS and a minimum of 5-7 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. Must have experience working with CMC on Phase 1-2 manufacturing.

Preferred Qualifications:

• 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.

Apply Now

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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

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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

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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

Apply Now