DIRECTOR, CLINICAL PHARMACOLOGY

The incumbent will work with various internal departments and external organizations, develop and execute clinical pharmacology and pharmacometric strategies across the ImmunoGen portfolio, participate in the design of clinical and relevant non-clinical studies, interpret, present and report clinical and non-clinical study results.
Full Time On-Site/Hybrid Pharmacology
Annually: USD 0 - 0
Director Pharmacology
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Available Locations:
Waltham, Massachusetts, United States
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 Clinical team. This role will have a range of responsibilities within the Clinical Development functional area and will report to the Head of Clinical Pharmacology. The incumbent will work with various internal departments and external organizations, develop and execute clinical pharmacology and pharmacometric strategies across the ImmunoGen portfolio, participate in the design of clinical and relevant non-clinical studies, interpret, present and report clinical and non-clinical study results.

Responsibilities

  • Develop an overarching clinical pharmacology strategy from IND to BLA to support regulatory submissions for multiple clinical stage programs
  • Independently perform NCA and population PK/PD analyses and implement optimal dose-finding strategies to ensure safe and effective advancement of clinical programs
  • Evaluate and select CROs and manage outsourced population PK, PK/PD, and exposure-response analyses for clinical programs
  • Design and oversee clinical pharmacology components in clinical studies to evaluate PK in special populations, such as pediatric and geriatric patients or those with renal and hepatic impairment
  • Propose, design and execute relevant non-clinical ADME and PK/TK studies, analyze and report results from these studies
  • Contribute to the relevant sections of the IB, eCTD modules, clinical study protocols and reports, DSUR, and briefing documents in close partnership with clinical, medical, regulatory, biostatistics, and medical writing professionals

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

  • PhD, Pharm D, or equivalent training in clinical pharmacology, pharmacokinetics, or related disciplines with a minimum of 5-7 years of working experience in clinical pharmacology
  • Highly proficient in NCA PK analysis and modeling and simulation using common software packages particularly the Phoenix WinNonlin and NLME modules
  • Strong understanding of clinical pharmacology principles with solid knowledge in drug metabolism and pharmacokinetics
  • Familiar with current regulatory guidelines for clinical pharmacology, bioanalytical methods, drug-drug interactions, general toxicology, and immunogenicity
  • Knowledgeable in the development of biologics including antibody-drug conjugates
  • Demonstrated skills in managing priorities and communicating with matrix and functional teams

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.

Posted 11 months ago

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