Deciphera Pharmaceuticals Inc.
Job Title: Director, Translational Medicine
Job Number: 22126
Location: Waltham, MA
The Director, Translational Medicine reports to the VP of Clinical Development and Translational Research. The Director role is a highly integrated role and will be responsible for developing, implementing and executing translational research strategies to support drug development programs at Deciphera Pharmaceuticals. This individual will act as the Translational Medicine Head, responsible for biomarker studies and analysis of patient data. The successful candidate will effectively interact with project teams, clinical research physicians, clinical statisticians, contract research organizations, academic experts, and internal translational research scientists to deliver science that supports the development and access of medicines to patients in need.
- Design and execute translational research plans supporting clinical development programs at Deciphera
- Leading development and implementation of asset-specific translational strategies (e.g. mechanisms of drug efficacy, mechanisms of resistance, rational combinations, new indications, patient segmentations, and product differentiation)
- Development and delivery of biomarker components of Deciphera clinical trials, including protocol development, translational plans, and study conduct (assay development and implementation, ownership of quantity and quality of biosamples) and companion diagnostics.
- Analyzes biomarkers for Deciphera clinical studies by working with relevant functions and CROs; responsible for creating SOWs and interfacing with CRO for execution of services
- Evaluates CROs for assay and data analysis capabilities
- Represent translational research at management meetings and to external stakeholders
- Travel to scientific meetings, advisory boards, CRO’s, and other sites as required
- Work closely with project management to develop, manage, and deliver translational research timelines, budgets, metrics, and milestones
- Author study reports, biomarker components of clinical protocols, patent applications, regulatory submissions and peer-reviewed publications
- Contribute to the preparation of documentation required for regulatory submissions including INDs and NDAs
Oversee any transfer, validation, sample analysis monitoring, and report generation as necessary
Interface with Deciphera Discovery Group regarding preclinical understanding of drug mechanism, drug resistance, and preclinical biomarker readouts
Interface with Deciphera Nonclinical regarding their conduct and support of certain clinical Biomarker assays.
- MD/PhD or PhD in life sciences or medical sciences, and a minimum of 10+ years of biotechnology or pharmaceutical industry experience, with 5+ years in clinical development.
- Must be a rigorous scientist with a track record of effective collaboration, influential communication, and clear impact in drug development.
- Must be a motivated, results-oriented self-starter, who enjoys learning and working in a fast-paced, dynamic team environment.
- Broad understanding of drug discovery and development, especially late stage development
- Experience (5+ years) in clinical development in an industry setting is a must, with experience supporting NDAs and developing CDx
- Knowledge of clinical biomarker discovery, development and analysis, including drug mechanism research, assay development/validation, and state-of-the-art genetic analysis platforms
- Knowledge of GLP, assay validation methodologies, and regulations that apply to clinical laboratory studies that support regulatory submissions is desirable
- Comprehensive knowledge of tumor cell biology, including genomics; experience with solid tumors
- Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
- Strong publication record
- Strong verbal and written communication skills
- Keep management abreast of current scientific thinking
- Role model for scientific excellence.
- Independent, scientifically-directed, and innovative thinking.
- Subject matter expert and functional group advisor on science, technology, methods, etc.
- Excellent organizational skills
- Ability to manage scientific collaborations and contracted research
- Effective team teamwork and collaboration skills
- Detail-oriented, with the ability to identify and implement creative solutions
- Ability to prioritize and manage time efficiently
- Familiar with industry trends and competitors position.
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.