Clinical Program Operational Lead
Millipore Corporation

We are looking for a dedicated Companion Diagnostics (CDx) Lead who is passionate about driving innovation in the field of Precision Medicine and making a meaningful impact. In this role, you will be instrumental in the development and execution of CDx strategies and in driving CDx projects to support Precision Medicine based drug developments. You will lead CDx projects considering the needs of the therapeutic program, technological advancements and a dynamically changing regulatory and competitive environment. You will work collaboratively with external diagnostic partners to ensure the successful and timely delivery of CDx projects while adhering to budget and regulatory requirements. Additionally, you will be responsible for evaluating new CDx partners and technologies, representing the CDx function in global program teams, and communicating CDx strategies to internal governance bodies. You will strongly collaborate with cross-functional teams to ensure successful implementation of biomarker testing in clinical trials and provide support to commercial functions from a diagnostic perspective. If you are ready to take on this exciting opportunity, we encourage you to apply!

Who you are:

Minimum Qualifications:

PhD or equivalent with a minimum of 8 years of experience in the pharmaceutical and/or diagnostics industry, including 5+ years in a similar role.

Preferred Qualifications:

In-depth expertise in CDx product development, regulatory requirements, and commercialization aspects.Proficiency in diagnostics technologies such as NGS, PCR/dPCR, and IHC.Expertise in Precision Medicine clinical developments in Oncology; experience in antibody-drug conjugates and/or DNA damage repair is a plus.Proficient in writing and reviewing documents supporting regulatory submissions.Familiarity with clinical laboratory and medical device quality requirements.Proven track record in a matrix leadership role and managing external partners.Ability to work effectively in multidisciplinary pharmaceutical/diagnostic teams.Excellent communication and presentation skills, with the ability to lead, influence, and inspire others.Willingness to travel domestically and internationally, up to 20%. Location: At least 3 days/week in our Billerica office