Sr Clinical Pharmacology Lead at UCB Inc. in Cambridge, Massachusetts

Job Description:

JOB DESCRIPTION

Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better. At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?

We are currently seeking a Senior Clinical Pharmacology Lead to head the development and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships of therapeutic molecules. By integrating PK, PD, pharmacogenetic, demographic and disease knowledge, the individual will be critical in leading the strategy and implementation for optimizing and driving insightful drug development plans in support of UCB-Ra Pharma novel small molecule and peptide therapies. Primary responsibilities will include leadership of program-specific clinical pharmacology strategies, analysis and interpretation of PK/PD data, and modeling and simulation in support of a rapidly growing portfolio. The individual will lead and influence globally, being part of the global Quantitative Pharmacology and DMPK and Quantitative Clinical Pharmacology Leadership Teams. Candidates should be self-motivated with experience working and leading in a highly collaborative cross-functional environment. This person will be based at UCB's Boston R&D Hub in Cambridge, MA and report to the Head US Development Science & Nonclinical Safety.

You will contribute by:

• Leading Clinical Pharmacology to support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the general population and subpopulations.


• Providing expertise and know-how in designing and implementing clinical pharmacology strategy in clinical trials during all clinical phases


• Interacting with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to clinical pharmacology and drug development


• Addressing and resolving scientific issues arising in drug discovery/development programs


• Developing as a Development Science matrix leader, driving the overall integrated strategy for (QCP, bioanalytics, non-clinical safety, DMPK, and pharmacometrics) at the development team for assigned projects


• Mentoring and supervising other staff locally or globally

Interested? For this position, you'll need the following education, experience, and skills:

Minimum Qualifications:

• Ph.D., PharmD, or M.D. in pharmacokinetics, biopharmaceutics, pharmacology, or a related discipline


• 10+years of Pharma industry experience


• 5+ years of direct experience with modeling and application of quantitative clinical pharmacology including pharmacometrics and other model-based approaches to guide drug development

Preferred Qualifications:

• Experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).


• Experiencewith the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting


• Experience working on the development of small molecules, biologics and ideally gene therapies


• Ability to solve technical problems with enthusiasm in a global team environment


• Good written and oral communication skills

Why you should apply:

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you'll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve. If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

About Us:

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 8,000 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our websitewww.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.