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DIRECTOR, REGULATORY CMC


ImmunoGen, Inc.


Location

Waltham, MA | United States


Job description

Overview:

Work Locat ion: US Headquarters, Waltham, MA (3 Days / Week in Office)

About the Role

Cancer doesn’t care how it disrupts the course of lives. We do. Since our founding, we have pursued one goal: develop targeted cancer therapies to improve outcomes for cancer patients. This singular focus has positioned us as a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer. At ImmunoGen, each of us is driven by a shared conviction that by advancing precise, targeted cancer therapies, we have the power to offer more good days to patients and their families ― now. It is why we come to work each and every day, and it is what will continue to motivate and energize us in the years to come.

 

ImmunoGen, Inc. is in search of a highly motivated team-player to join our Regulatory Affairs department. Reporting to the Executive Director, Regulatory CMC, this individual will be responsible for providing leadership as part of a global regulatory team supporting Immunogen’s regulatory CMC strategy for clinical and commercial products. They will work with the Regulatory CMC project lead, providing strategic regulatory input to support and implement the Product Team decisions. The successful candidate will also contribute to the lifecycle management strategy for clinical and commercial assets and consult with the Supply Chain Team on supply plans. They will participate in regulatory meetings, providing insights into regulatory requirements and expectations throughout the lifecycle of the products.

 

This is a great opportunity to bring your regulatory and industry knowledge and creativity to the CMC challenges associated with antibody-drug conjugate (ADC) products that have both biologic and small molecule components, developed under the accelerated timelines typical of oncology products.

Responsibilities:

Life at ImmunoGen

At ImmunoGen, we are looking for forward-thinking talent with diverse experiences and a track record of success, leadership skills, a demonstrated ability to take initiative, and a passion for improving the lives of those living with cancer. To succeed here is to care ― care about what we do, why we do it, and each other. We are working hard to bring hope to our patients and their families, which inspires our teams to aim high and honor our commitment to continuous improvement.

 

At ImmunoGen, collaboration is not a construct. It is at the core of everything we do and shows up in how we work every day. Here, your ideas and experience matter. We value driven individuals who thrive in a fast-paced environment; who can think about our future and see the promise before us; who anticipate risks and opportunities; who are willing to learn and adapt to change; who are inclusive and eager.

 

Together, we rise to the challenge before us, advancing our programs on the strength of our deep scientific and commercial expertise and energized by the opportunity to change long-standing treatment paradigms. We pride ourselves on the work that we do, and know that it is a privilege to work in the oncology space and to dedicate our days to helping patients .

 

Our Unique Opportunity

It’s an exciting time for our organization. The US FDA recently granted accelerated approval for ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, marking our transition into a fully-integrated oncology company. This is just the beginning, as we embark on an exciting new chapter as a leader in the development and commercialization of innovative oncology products.
Joining ImmunoGen now will give you the unique opportunity to create a lasting impact ― to make your mark on the work that we are doing by leveraging your experience to shape our first commercial launch and the go-forward organization.

Qualifications:

Our Benefits

We believe in the potential of our people and foster a supportive environment that develops our folks, rewards performance, and incentivizes long-term success. From excellent benefits and competitive compensation to ownership in the company, we want to inspire our employees.

 

Our benefits include, but are not limited to:

About ImmunoGen

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 .

 

At ImmunoGen, targeting a better life for people with cancer is what we do, and we believe that a diverse and inclusive team is essential to achieving this. We strive to create a workplace that reflects the communities we serve and where everyone feels empowered to bring their full, authentic selves to work. There is work to be done and with the help of our entire team — our employees, customers, partners, and community — we can deliver more good days to those who need them most.

 

ImmunoGen is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

 

ImmunoGen does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen's approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen by search/recruiting agencies not already on ImmunoGen’s approved agency list shall become the property of ImmunoGen and if the candidate is subsequently hired by ImmunoGen, ImmunoGen shall not owe any fee to the submitting agency.

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Holiday workFull timeFlexible hours3 days per week


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