Head, US Development Science Job at UCB in Cambridge, Massachusetts
Help us transform patients’ lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?
The Head of US Development Science will be expected to be a key contributor to developing UCB’s pipeline by leading the US Development Science organization. In addition will work seamlessly from research into clinical development interacting with all relevant discovery and development functions.
You like to work in an environment where you can:
Lead the US Development Science team
- Member of the Global Development Science Leadership team, ensuring coordination and optimal impact of expertise and resources within the Global Development Sciences organization
- Leads the US Development Science team as leader attracting, retaining a strong talent pool providing strong managerial leadership
You will contribute by:
For US-led project focus:
- Lead toxicology, DMPK and Clinical Pharmacology to oversee relevant studies required at the different stages of discovery and development
- Oversight of IND-enabling nonclinical safety, DMPK, PK/PD, Modeling and Simulation.
- Leadership and coordination with Global Development Science of the stage-appropriate development and implementation of all relevant Development Science assays for Non-Clinical and clinical studies.
- Provide strategic and hands-on management ensuring that toxicology studies are conducted in line with the appropriate regulatory guidelines and standards (FDA, WHO, GLP, and ISO).
- Accountability for US Development Science budget.
- Initiate and manage contracts in conjunction with finance group, coordinates activities with selected Contract Research Organizations (CROs) and academic collaborators for Non-Clinical Development in the areas of toxicology, pharmacology, pharmacokinetics.
- Prepare reports, regulatory documents and INDs.
- Work closely with US and Global functional areas and colleagues to ensure all studies are performed in a quality, timely and scientific manner.
- Provide Non-Clinical expertise, and strategy, to multi-functional project teams as the Non-Clinical representative
- Represent Development Science in internal and external discussions as a key expert of Development Sciences including internal governance as well as interactions with regulatory agencies
- Ensure compliance with GXP, and regulatory guidelines as appropriate.
Interested? For this position you’ll need the following education, experience and skills:
- Ph.D., PharmD, M.D. with relevant training in veterinary medicine, toxicology, pharmacokinetics, biopharmaceutics, preclinical or clinical pharmacology, or related disciplines and a minimum of 5-7 years of industry experience.
- The successful applicant should have experience in providing input plans and the preparation of regulatory submissions in the area or preclinical and/or clinical development (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
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 7,500 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 website www.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.
Company Location: Cambridge, Massachusetts