Company: Loxo Oncology, Inc.
Posted on: January 11, 2019
Reports To: Associate Director, Clinical Scientist Position Summary Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work. This position offers the opportunity to participate in the entire spectrum of the drug development process. Loxo designs drugs "from the ground up" by selecting a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. This role is integral in moving this drug "from the bench to the bedside", from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval. The Clinical Scientist will participate directly in improving the lives of people fighting their cancers. Roles and Responsibilities of the Position* In tandem with the Medical Director this role designs, implements and executes Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as the position interacts with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders. Loxo is a small company highly focused on clinical and regulatory execution. As a key member of the team, the Clinical Scientist will have the opportunity to work and learn in a fast-paced, team-oriented and exciting work environment that will literally change the lives of cancer patients for the better. The Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring of clinical development programs. These programs include early proof of concept through registration in a variety of targets and may involve collaborations with corporate development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This individual must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.* Serve as the clinical science representative on global and regional clinical execution teams.* Creates and fosters strong strategic partnerships with colleagues that include Clinical Operations/Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management and pre-Clinical Development.* Lead the design, implementation, operations/study management and interpretation of clinical trials.* Lead the writing of protocols, informed consent forms, clinical study reports and regulatory-related documents.* Work closely and liaise regularly with clinical sites and investigators to ensure implementation of clinical studies.* Review, interpret, and present clinical data from development program and the relevant literature at relevant scientific meetings.* Support the writing of subsequent regulatory briefing documents.* Lead and be accountable for study start up activities, site initiation visits, interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.* Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget and time-constraints, in partnership with CROs and Loxo regional and in-country groups, to deliver submission-quality data.* Demonstrate efficiencies in the areas of budget management, contracting and resourcing.* Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.* Work with external experts to develop abstracts, manuscripts, study/program design and presentations.* Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.* Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.* Proactively generate ideas for improvements and act to solve problems and achieve goals beyond what is required. Required Qualifications and Background* PhD, PharmD or M.D.* The ideal candidate will have 5 years of biopharma experience in an academic or industry setting and at least 2+ years medical/clinical scientist experience in oncology. At least 5 years clinical research experience preferred, particularly in drug development in oncology.* Clinical trial expertise with experience in oncology with drug development highly desirable.* Must possess a strong background in clinical trials in an academic or industry setting.* Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.* The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.* The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.* Travel up to 20%, may include international travel In summary, qualities sought include: intrinsic motivation, excellent communication and organizational skills; a passion for biomedicine and for patients; broad prior experience in drug development; and a comfort and desire to learn new skills. Physical Demands / Travel This position requires approximately 20% travel, which will fluctuate as business imperatives change. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Work Environment This position's work environment is based in the field, occasionally in a lab and within a typical office setting. The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.* To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Apply Now
Keywords: Loxo Oncology, Inc., Denver , Clinical Scientist, Healthcare , Boulder, Colorado
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