About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.
The Opportunity
ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, is seeking a Senior Medical Director to contribute to the growth of an expanding clinical group at ImmunoGen, Inc. Reporting to the Chief Medical Officer, the Senior Medical Director will provide leadership and expertise in the company’s clinical studies of novel therapeutics in hematologic malignancies. Clinical studies are underway or planned for proprietary ADCs that target cell surface antigens expressed in Non-Hodgkin Lymphoma and Acute Myeloid Leukemia, as well Ovarian and Endometrial Cancers.
The Senior Medical Director will be focused on the design, conduct, and execution of clinical trials, along with data analysis and presentation to support indications in hematologic malignancies. Individual who assumes this position will interact with multiple levels of management within ImmunoGen, external stakeholders in the medical community, and with global regulatory authorities.
- Provide strategic clinical leadership for our Hematologic Malignancy programs.
- Provide clinical input to optimize new product development for successful launch into the marketplace and lifecycle management.
- Responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and NDA documents.
- Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs.
- Travel, as needed, nationally and internationally.
Who You Are
- MD degree with substantial experience in design and interpretation of clinical trials and a substantial track record of clinical research (in hematology, oncology and/or orphan diseases preferred).
- At least 3-5 years of active medical or academic practice in hematology/oncology with at least eight plus years relevant experience in the pharmaceutical/biopharmaceutical industry is desired.
- Thorough understanding of Phase I-III drug development with proven ability to plan and conduct clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents.
- Excellent written and verbal communication skills, as evidenced by a record of publications and public speaking.
- Track record of success and impact working across many interfaces at a senior level within a complex matrix organization with demonstrated ability to successfully interact with external partners.
- Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.
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.