- Experience Level
- Experienced (non-manager)
Location: Waltham, MA (USA)
AstraZeneca is seeking a proven Senior Clinical Pharmacologist that will support small and large molecule projects within Oncology.
The Senior Clinical Pharmacologist is a scientific job which works closely with the clinical team to create clinical pharmacology development program to provide differentiated medicine and the right dose to patients. You will apply state-of-the-art Clinical Pharmacology and Model-Based Drug Development (MBDD) approaches to influence designs and internal/external decision making at the project level. You will support global initiatives to develop the clinical pharmacology discipline and at times mentor junior staff. You will work closely with project colleagues to ensure appropriate implementation of state of the art clinical pharmacology program based on model based drug development (MBDD).
Accountable for planning and executing state-of-the-art clinical pharmacology program with direct value on specific projects including go/no go decision making
Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at internal (project/governance) and external interactions (investigator meeting/conference/health authorities)
Jointly accountable with the pharmacometrician for providing a scientific justification for the dose selection
Contribution to the identification and development of drug-disease models and other modelling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant)
Support evaluation of candidates for in/out-licensing
Contribute to internal initiatives to develop the clinical pharmacology discipline including its processes
Participation in and accountability for peer review of ongoing activities, reports and presentations
Supervision of clin pharm work performed by external contractors and more junior clinical pharmacologist, graduate students and post-doc
Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance's
This position is located in Waltham, MA
The AstraZeneca R&D Waltham site is dedicated to cutting edge drug discovery, the facility is now a dynamic center where scientists from a variety of companies come together to share ideas and push the boundaries of science, with more buzz and more people than ever before!
Th Waltham site is one of three AstraZeneca R&D sites to be transformed into a BioHub, along with Molndal, Sweden and Alderley Park, UK, where AstraZeneca researchers are working side-by-side with scientists from academic institutions to make strides in scientific discovery. AstraZeneca believes in what science can do and values the partnerships that contribute to the discoveries that ultimately help patients.
Senior Clinical Pharmacologist
PhD degree preferred; M.Sc. or Pharm.D. required
Demonstrated broad translational and clinical development expertise and experience exemplified by at least 3 years of industry drug development experience, with emphasis on Clinical Pharmacology
Associate Director Clinical Pharmacology
PhD degree preferred; M.Sc. or Pharm.D. required
Demonstrated broad translational and clinical development expertise and experience exemplified by at least 6 years of industry drug development experience, with emphasis on Clinical Pharmacology
Essential Skills and Abilities;
Expert knowledge of pharmacokinetics and Model-Based Drug Development
Expert knowledge in pharmacology, drug targets and core disease areas
Demonstrated ability to identify, develop and execute clinical pharmacology activities at a project level
Excellent oral and written communication skills
A demonstrated knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology
Relevant regulatory experience (written/oral)
Training and experience with PK software (Phoenix, WinNonlin
International scientific reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology
Experience in early and late stage drug development
Experience with relevant software and tools within the field of MBDD (e.g. SIMCYP, R, NONMEM) (T)
Good leadership capabilities, in particular with regards to influencing skills
Please contact: Karthick Vishwanathan at Karthick.firstname.lastname@example.org
AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, offers valuable choices, and is highly competitive.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
Come and join our journey - Apply today!
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