Job Description
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.
Principal Duties and Responsibilities
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
Prepare summary reports for regulatory submissions; and assist in the preparation of DMPK, BioAnalytical, safety pharmacology and toxicology sections for Investigational New Drugs (INDs), annual reports, Investor Brochures (IBs) and New Drug Applications (NDAs).
Will also serve as DMPK / toxicology expert on internal project teams, participate in generating written responses to inquires received from regulatory agencies, and prepare peer-reviewed scientific publications.
Job Qualifications
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
Monte Rosa Therapeutics rational approach in targeting disease-causing proteins for degradation will deliver pioneering therapies for cancer and other diseases. Delivering this new generation of treatments to the patients requires a conceptual change. Monte Rosa recognizes this urgent need and is missioned to develop innovative protein degraders as a solution. Combining deep knowledge, insight and leading-edge science, our integrated engine is built for that purpose.
