AD, Clinical Research

Company: ImmunoGen, Inc.
Location: Waltham
Posted on: June 8, 2021

Job Description:

Overview

Who We Are 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." Learn more about who we are, what we do, and how we do it at www.immunogen.com.

Responsibilities

The Opportunity This position is responsible for working with the physicians and cross functions within Clinical Development and ImmunoGen to provide clinical research support for programs as assigned by phase Applies disease clinical knowledge to clinical research development Keeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development and regulatory requirements Responsible for assigned product level activities related to the compound, clinical trials, scientific, regulatory and program strategy Leads protocol development Key contributor/reviewer of study related manuals/documents, CRFs, and study plans Participates in and prepares clinical development plans Leads IB development and updates Collaborates with PVG to draft/update ICF risk language Drafts applicable sections of clinical scientific documents such as IND, IND amendments, Investigator Brochures, cohort review committee management plans, and other FDA/EMA submissions Leads CSR preparation and finalization Supports medical monitor in the review of safety and efficacy data in ongoing studies; monitors GCP compliance along with clinical operations and CRO In consultation with medical monitor, responds to eligibility questions from CRO and site Collaborates with the medical monitor to identify program risks and develop mitigation strategies Leads investigator calls and cohort review meetings; key contact for Investigators and study staff Responsible for clinical data updates for upper management meetings, safety review team meetings and other internal meetings Assists with clinical abstracts, assists and/or presents data at scientific meetings, SIVs; conducts protocol training Serves as a scientific and/or clinical liaison to project teams, clinical operations, CROs, and others Participates with clinical operations in the CRO/vendor selection Trains internal, CRO, and site staff on protocol and other study issues Authors clinical sections of regulatory documents (briefing documents, responses to health authorities, etc.)

Qualifications

Who You Are Degree in scientific/life-sciences/clinical/nursing field. M.S., Ph.D. preferred Minimum of 8 years of experience with at least 3-5 years of clinical drug development experience Prior hematology, oncology or immunology disease drug development experience a plus Prior late (Phase 2/3) development experience a plus Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment Excellent written and oral communication skills Strong analytical ability 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 , AD, Clinical Research, Other , Waltham, Massachusetts