Late Phase Clinical Pharmacologist

The Position

In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.  

This position is located in Translational DMPK-PD and Clinical Pharmacology, a chapter within the Pharmaceutical Sciences (PS) function, where providing the right drug at the right dose to patients safely with an efficacious benefit is the primary focus. We closely collaborate with our therapeutic areas and functions to convert hypotheses into innovative therapeutics. Job Mission 

As an accomplished Clinical Pharmacologist with extensive experience in late-phase development and regulatory filings, you lead and have overall responsibility and accountability for all clinical pharmacology components of drug development, including the modelling and simulation strategy and BioX strategies. 

In addition, you will represent clinical pharmacology in Global Development Teams and Life Cycle Teams and on the PS portfolio squads. He/she will apply high medical, scientific, and ethical standards to define the clinical pharmacology characteristics (safety, pharmacokinetics, and pharmacodynamics) of investigational drugs in a cost and time-efficient manner. Your Impact 

You develop the timely, scientifically sound, business-oriented clinical pharmacology components of the assigned product development plan, and CDP and prepare in a timely manner and with high quality, relevant documentation (including protocols and amendments, CSRs, NDA/BLA summaries) and the clinical pharmacology component of other high-level documents (CDP, Life Cycle Plans, INDs, package inserts)

You will lead the quantitative clinical pharmacology subteam of clinical pharmacologists and clinical pharmacology scientists, pharmacometricans and other scientists and you co-lead the BioX teams

You deliver high-quality evaluation and interpretation of clinical pharmacology data from clinical studies

You deliver responses to regulatory agency questions, prepare advisory committee meetings and prepare for all interactions with regulatory authorities with regard to clinical pharmacology issues

You coach and mentor team members on relevant clinical pharmacology, medical, regulatory, and business knowledge with trustful relationships

Your Profile

You bring a PharmD, an MD or a PhD in an area relevant to clinical pharmacology 

You have more than 10 yrs of experience in clinical pharmacology in the biopharmaceutical or related industry. 

You bring a strong desire or the ability to learn Phoenix, Berkley Madonna, Gastroplus, SimCyp or other relevant modeling and simulation tools for your work.  

You have filing experience with EMA/FDA and other health authorities including, writing high-quality submission documents and briefing packages and knowledge of regulatory guidelines

You have an excellent understanding of clinical pharmacology, pharmacokinetics and pharmacodynamics as well as strong communication skills.

You enjoy leading teams in a matrix environment and clearly define deliverables and objectives., and 

You have a demonstrable ability to work effectively with multiple health authorities, including writing briefing packages for EoP1/EoP2 meetings and leading the clinical pharmacology team in these, as well as regulatory submissions including NDAs/BLAs/MAAs.

Your location: the position would be based in Welwyn in the UK or Basel in Switzerland.  Our Commitment

Roche commits to recognizing talent and aptitude. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career.

We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.

Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.