SENIOR MEDICAL DIRECTOR, PHARMACOVIGILANCE

Full Time Remote in United States Pharmacovigilance Senior Director Apply for this Job 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 is currently looking for an individual to join our Pharmacovigilance (PV) Department. The Sr Medical Director will play a pivotal role within PV to develop and maintain safety assessments for all ImmunoGen products. This individual will provide scientific/clinical expertise, strategic safety oversight, support for deliverables and activities associated with pharmacovigilance deliverables at ImmunoGen Utilizing effective communication skills will be key, as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs.

This candidate should be capable of representing Immunogen PV at internal and external meetings and must be versed in policies and procedures regarding PV and product quality that align with prevailing FDA, EU, and other locally applicable regulations.

In addition, this individual will be expected to utilize their depth of experience in PV both in developmental and marketed products to help the department build infrastructure, develop processes, and provide input in long-range planning. The individual will also strategize with senior management with regards to the growth of medical safety strategy function within PV as ImmunoGen continues to evolve in the industry.

Responsibilities

• Contribute to establishing, enhancing, and implementing robust surveillance and benefit-risk processes within PV based on clinical, scientific, and pharmacovigilance expertise to provide strategic support for products across the lifecycle.
• Implement a risk management process starting early in the IMGN product(s) development. Work with clinical teams to develop risk management plans to support regulatory submissions.
• Oversee signal management and risk management activities of assigned IMGN products on a global basis across the life cycle, starting with early development.
• Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities.
• Communicate and interact effectively within and across therapeutic teams, and within functional team management as appropriate.
• Work with labeling, publications, and commercial teams to accurately portray the safety profile of assigned IMGN products.
• Work closely with PV Scientists and PV Operations team to provide medical input to deliverables such as signal detection activities, safety data review, case processing, and periodic reporting.
• Build relationships and liaise with clinical/medical counterparts across the business to provide PV expertise as needed.
• Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6- monthly line-listings; EU Annual Safety Report; DSUR)
• Review and provide medical safety content, as needed, for key study-related documents, e.g. IB, ICF, SMC/IDMC Charters
• Provide input to Pharmacovigilance agreements and support alliance interactions
• Participate in protocol development to ensure alignment with risk management plans.

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

• Experience in clinical and post-marketing safety surveillance and pharmaco-epidemiology
• Knowledge of current pre- and post-marketing US and International safety regulations
• Advanced ability to analyze and interpret clinical data.
• Ability to contribute to and/or lead activities in a fast-paced and changing environment and to ensure high-quality results are delivered in a timely manner.
• Strong experience in the medical review of SAE cases
• Experience and training in MedDRA coding and coding review
• Strong organizational skills and ability to manage multiple projects.
• Excellent oral and written communication skills
• Thorough knowledge and experience in all aspects of safety reporting for CTs and marketed products.
• In-depth knowledge of safety regulations (PM and CT) and excellent understanding of global health authority requirements pertaining to drug safety and risk management including ICH, CFR 21, FDAAA, and EU GVP modules, and able to influence decisions at all levels relating to patient safety.
• High EQ and strong interpersonal skills that facilitate collaboration across functions.

Education and Experience

• M.D. degree or equivalent with a minimum of 5-7 years of experience in PV organizations in the pharmaceutical/biotechnology industry is required. Oncology experience will be a significant advantage.
• Previous experience as lead safety physician for CT and marketed products
• Experience in signal detection with demonstrated experience in analysis, and interpretation of medical and scientific data.
• Experience in safety data analysis and writing study-related aggregate reports and safety assessments.
• New product launch experience desired

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:

• Competitive salary and bonus plans
• Top-tier health, vision, dental, and life insurance
• Generous paid holidays, time off, and parental leave
• Comprehensive package of benefits plans
• 401K Retirement Savings plan offering a company matching contribution
• New hire and annual restricted stock unit and stock option awards for all employees
• Tuition reimbursement
• 3:2 office workday for flexible working arrangements
• Stipends for learning opportunities

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 www.immunogen.com.

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.