- Entry level
- No Education
- Salary to negotiate
At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.
That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
The role of the ID Clinical Pharmacology Section Head is to support the I3 DTA Clinical Pharmacologist (I3 DTA CP) to provide Clinical Pharmacology scientific and operational expertise, to maintain and further the development of functional excellence, and to act as deputy for the I3 DTA CP as needed. The ID Clin Pharm section head will lead a group of clinical pharmacologists (CP) supporting the ID portfolio. The ID Clin Pharm section head will take on project assignment as needed.
Major Responsibilities and Accountabilities:
Be the primary line manager of a group of clinical pharmacologists (CP) supporting the ID portfolio.
Develops and maintains specific scientific clinical pharmacology expertise in the assigned DTA. Establishes and manages external contacts and alliances in these fields and ensures that knowledge for the assigned areas is shared.
As deemed appropriate, the role may include responsibility and accountability for the following:
- Act as deputy for I3 DTA Clinical Pharmacologist as needed (i.e. DRC, DTA PC, Briefing package review).
- Working dedicatedly and in co-operation with competent agencies to address local/national issues likely to affect clinical pharmacology studies (ethical, legal and practical).
Development and execution of the clinical pharmacology aspects of the eCDP or the Life Cycle development plan.
Leads or contributes to expert working groups within Clinical Pharmacology with the aim to establish guidance’s and standard methodologies for efficient implementation of new techniques and processes.
Provides mentorship and scientific leadership within the assigned DTA.
Establishes, promotes and maintains effective working relationship with other Roche partners, departments and functions as required.
Participates in multidisciplinary teams evaluating potential in-licensing candidates.
Responsible for coaching and mentoring other staff within the clinical pharmacology department and, if they have line management responsibilities, also responsible for recruitment, development and performance management of their staff.
These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual.
You are an MD, PhD or PharmD graduated with at least 10 years’ experience in clinical pharmacology and a thorough knowledge of drug development.
Infection diseases area expertise & project experience.
In-depth knowledge of the drug development process, participation in the preparation of a successful NDA.
Successful track record working with government agencies e.g., FDA, CHMP/EMEA.
Excellent planning and organisational skills
Deep understanding of pharmacokinetics, pharmacodynamics and the physicochemical, physiological and biochemical basis of drug properties. Integration of such information into a mechanistic framework focusing on the causal pathway for the desired action of the drug as well as any potential safety and tolerability concerns.
Expert knowledge in areas of the pre-clinical development package required to enable clinical trials
Generating early clinical development scenarios to follow up on proof of concept and any DMPK, safety alerts in pre-clinical to profile a molecule in man
Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills.
The more inclusive we are, the better our work will be.
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.