Associate Director, Clinical Pharmacology
Description

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.


Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.


Job description

The successful candidate will have the opportunity to use quantitative methodologies to shape the overall clinical development plan for Morphic drug candidates. The position will be part of a multi-disciplinary drug development team working together towards transformative small molecule therapeutics for autoimmune and fibrotic diseases. In-depth experience in quantitative PK and PD data analysis is required.


Responsibilities

· Contribute to the planning, trial design and data analysis for clinical studies including SAD/MAD, drug-drug interaction, biopharmaceutics, special population studies, human ADME, and thorough QT studies

· Perform clinical and non-clinical PK and PK/PD analysis and communicate analysis outcomes to internal and external stakeholders. 

· Assess and integrate knowledge of PK, PD, safety, and patient characteristics to design dosing regimens; Participate in the preparation of clinical study protocols and data analysis plans  

· Oversee and liaise with CROs for population based pharmacokinetic/pharmacodynamic data analysis; Draft and/or review clinical PK reports and incorporate PK/PD sections into clinical study reports and relevant CTD components for regulatory submissions

· Interface with nonclinical and clinical development colleagues such as clinical sciences and regulatory, and provide expert input in interactions with and responses to regulatory agencies


Qualifications

· 7+ years’ experience and a PhD or PharmD degree with emphasis in pharmacokinetics, clinical pharmacology, or a related scientific discipline

· In-depth knowledge of pharmacokinetic (WinNonlin) and working knowledge of population based PK/PD analysis software such as NONMEM, Monolix, R, or other modeling platforms

· Excellent written and oral communication skills and ability to convey complex technical information clearly to the team; Proven track record of working effectively in a dynamic, collaborative, team-oriented setting

· Understanding of PKPD, drug metabolism, and clinical research concepts and experience analyzing clinical dose-response and PKPD data; Knowledge of current regulatory guidance related to clinical pharmacology


Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.