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DIRECTOR, CLINICAL PHARMACOLOGY

Company: ImmunoGen, Inc
Location: Waltham
Posted on: September 12, 2020

Job Description:

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 reporting.

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 etc.)

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 pharmacology plans.

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 appropriate.

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 setting.

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 toxicology

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.

Keywords: ImmunoGen, Inc, Waltham , DIRECTOR, CLINICAL PHARMACOLOGY, Other , Waltham, Massachusetts

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