Sr. Director, Translational Medicine
Deciphera Pharmaceuticals
 Waltham, MA
Company Summary:
Deciphera Pharmaceuticals
is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.

We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
·       providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
·       a diverse and multi-disciplinary workforce
·       dedicated and talented people who are passionate about achieving excellence in all they do
·       a work environment that allows you to balance your priorities
·       above all else, a commitment to the patients we serve

This individual will act as the Head of Translational Medicine, reports to the VP of Clinical Development and Translational Medicine. The Sr. Director role is a highly integrated role and will be responsible for developing, implementing and executing translational medicine strategies to support early and late stage clinical development programs at Deciphera Pharmaceuticals. The successful candidate will effectively interact with project teams, clinical research physicians, clinical statisticians, academic experts, and internal translational research scientists to deliver science that supports the development and access of medicines to patients in need.  Additionally, this role will lead a team of highly skilled and passionate people located across two sites – Waltham, Massachusetts and our research site in Lawrence, Kansas.  In Lawrence you will have the opportunity to build-out and staff a translational wet lab.

Responsibilities

  • Design and execute preclinical and clinical biomarker 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, biomarker plan, and study conduct (assay development and implementation, ownership of quantity and quality of biosamples) and companion diagnostics if needed.
  •  Effectively communicate biomarker strategy and findings to key stakeholders internally and externally.
  • Work closely with project management to develop, manage, and deliver translational research timelines, budgets, metrics, and milestones
  • Provide leadership and mentoring to the translational medicine team in Waltham, Massachusetts and Lawrence, Kansas
  • Recruit and onboard new employees
  • Ensure delivery of high-quality biomarker study reports, biomarker components of clinical protocols, regulatory submissions and peer-reviewed publications
  • Contribute to the preparation of documentation required for regulatory submissions including INDs and NDAs
  • Closely interact with Deciphera Discovery Group regarding preclinical understanding of drug mechanism, drug resistance, and preclinical biomarker readouts.
  • Oversee any assay transfer, validation, sample analysis monitoring, and report generation as necessary

Qualifications

  • MD/PhD, MD or PharmD, and a minimum of 10+ years of biotechnology or pharmaceutical industry experience, with 5+ years in clinical development.
  • Strong leadership and communication skills, ability to build and mentor high-performing teams.
  • Experience (5+ years) in clinical development in an industry setting is a must, with experience supporting NDAs and/or developing CDx
  • Broad understanding of drug discovery and development, especially late stage development
  • Knowledge of clinical biomarker discovery, development and analysis, including drug mechanism research, assay development/validation, and state-of-the-art genetic analysis platforms
  • Must be a motivated, results-oriented leader, who enjoys working in a fast-paced, dynamic team environment.
  • 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
  • Travel to the Lawrence site will be required on a monthly to bimonthly basis