$160K — $250K
Director, Non-Clinical Development – DMPK & Toxicology
Location: Boston, MA or Basel, Ch
Monte Rosa Therapeutics is seeking for a “Senior Director/Director of Non-Clinical Development” to join our dynamic and growing organization. The role may be located in Boston or Basel, offers a tremendous opportunity to support our growing company in an experienced, vibrant and agile biotech team.
The Director of Non-Clinical Development will be responsible for the development and execution of integrated nonclinical DMPK, PKPD and safety strategies from target assessment through early clinical development. Oversees toxicology & DMPK studies, responsible for project deliverables. Provides data analysis and interpretation in preparation for final reports. Ensures regulatory submission and compliance. Works as part of a multidisciplinary team to support the conduct of pre-clinical studies. Interacts directly in research projects with multidisciplinary teams such as biology, analytical chemistry and outside CRO’s to bring discovery candidates into development. Performs quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission.
The successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, hands-on, strong analytical and organizational skills and strategic mindset.
· Accountable for design and execution of all nonclinical aspects of all development programs from early research to early clinical development.
· Responsible for key first-in-human enabling studies including toxicology and DMPK.
· Elaborate, establish, and implement DMPK optimization strategies with respect to understanding the PK/PD relationship, obtaining appropriate exposure in preclinical species for safety testing, minimizing potential safety liabilities and support human PK and dose predictions
· Manage, analyze, review, summarize, interpret and report results of DMPK and toxicology studies
· Oversee and manage studies with CROs and consultants
· A Ph.D. or equivalent degree in pharmaceutical sciences or other relevant bioscience discipline
· 10+ years of industry related experience in drug research & development
· Experience in small molecules is required, experience with small molecule protein degraders is a plus.
· Proven experience to work as project leader in cross-functional teams
· Proven success with development of oncology and/or immunology assets is preferred
· Knowledgeable of the mechanisms of small molecule disposition
· Experience with advanced PK and PKPD modeling software preferred but not mandatory
· Demonstrated knowledge of global regulatory requirements and expectations for nonclinical assessment packages to support first in human studies
· Demonstrated, active network with research centers, CROs, consultants and key opinion leaders
· Excellent communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, and board meetings
Valid through: 12/18/2020
$100K — $110K