Req Id 7101 - Posted 08/07/2020
- Job Posting Location (1) - Clinical
Development - Full-Time
ImmunoGen is developing the next generation of antibody-drug
conjugates (ADCs) to improve outcomes for cancer patients. By
generating targeted therapies with enhanced anti-tumor activity and
favorable tolerability profiles, we aim to disrupt the progression
of cancer and offer our patients more good days. We call this our
commitment to “target a better now.”
This individual will have a range of responsibilities within the
Clinical Development functional area and will be expected to
collaborate with medical directors, clinical scientists,
biostatisticians, translational scientists, researchers,
toxicologists and bioassay specialists to support projects in the
areas of oncology and hematology. This individual will report to
the Head of Translational Sciences and interact frequently with
Project Team Leads and Senior Management. The primary focus of this
role is to oversee the development of clinical pharmacology
programs from early research, through non-clinical development and
into clinical development including leading novel assay
development, sample management/tracking and data analysis and
Responsibilities to include:
Provide scientific leadership in clinical pharmacology to
support effective development of portfolio compounds with respect
to clinical pharmacokinetics, immunogenicity and ADME
Conducting PK, PK/PD and immunogenicity complex data analyses;
interpreting and reporting results
Being a key member of development teams and supporting clinical
trial operations and execution through authoring of analysis plans,
appropriate sections of clinical protocols, ICF’s, IB’s, DSUR’s
Oversee GLP and non-GLP Bioassay development, including ADA and
neutralizing antibody assays,provide input to non-clinical DMPK and
ADME programs and supervise preparation and execution of clinical
Support Drug Metabolism and Pharmacokinetics activity to ensure
an integrated and efficient approach.
Provide strategic direction to the writing and review of
clinical protocols, clinical study reports and Clinical
Pharmacology documents, meeting background packages, and other
documents submitted to regulatory authorities.
Interacts with regulatory agencies and advisory committees as
Manage department level budget and resources.
Who You Are
PhD or Pharm D with training in clinical pharmacology.
5-7 years hands on experience in the application of clinical
pharmacology within the context of drug development in a corporate
Expert knowledge in pharmacokinetics, immunogenicity, drug-drug
interactions, bioavailability/bioequivalence, special populations,
QTc assessment and dose selection.
Prior experience with ADCs is preferred
Knowledge of current practices, regulatory requirements and
issues in bioanalytics, biopharmaceutics, pharmacology, and
ImmunoGen, Inc. is an equal opportunity employer & prohibits
unlawful discrimination based on race, color, religion, gender,
sexual orientation, gender identity/expression, national
origin/ancestry, age, disability, marital and veteran status.
ImmunoGen, Inc. does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or
candidate information submitted to ImmunoGen, Inc. by
search/recruiting agencies not already on ImmunoGen, Inc. approved
agency list shall become the property of ImmunoGen, Inc. and if the
candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc.
shall not owe any fee to the submitting agency.