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Senior Director, Clinical Pharmacology

Employer
Theravance Biopharma
Location
South San Francisco, CA
Start date
May 22, 2019

Job Details

Job Description

The Senior Director of Clinical Pharmacology will serve as the Clinical Pharmacology representative on project teams, providing strategic leadership and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships for the purpose of optimizing drug regimens.  By integrating PK, PD, pharmacogentic, demographic and disease knowledge, the individual will be critical in optimizing and driving insightful drug development plans.

Principal Accountabilities:

  • Prepare clinical pharmacology development strategies for multiple small molecule compounds.
  • Design clinical pharmacology studies that yield high value PK/PD insight. Analyze PK/PD data and interpret results to maximally impact program goals.
  • Drive translational approaches via the clinical development plan from phase 0 to IV. Work closely with Research and Clinical Development to fully leverage and integrate the understanding of a compound and its biology.  Provide expertise and knowledge of translational aspects, including clinical biomarkers and modeling and simulation efforts.
  • Develop scientific rationale and concepts for personalized/stratified medicine to optimize patient outcomes.
  • Apply strong knowledge of best regulatory practices, technology and development precedent.
  • Support regulatory strategy and is responsible for clinical pharmacology sections of regulatory documents.

Job Requirements

Skills:

  • Has extensive knowledge and practical understanding of current clinical pharmacology within the realm of translational medicine and general drug development.
  • Understands and is able to apply appropriate regulatory and ICH guidelines in the design and execution of clinical pharmacology and clinical development plans.
  • Experience with immunology drug development is highly desirable.
  • Possess strong leadership and excellent communication skills. An ability to manage, mentor and develop direct reports would be an asset.

Experience:        At least 10 years of direct industry experience in clinical pharmacology.

Education:           Ph.D., Pharm.D. or M.D. in pharmacokinetics, pharmacometrics, clinical pharmacology or related fields.

Company

Theravance Biopharma is a diversified biopharmaceutical company with the core purpose of creating medicines that help improve the lives of patients suffering from serious illness.

Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. Our research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop intestinally restricted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases.

In addition, we have an economic interest in future payments that may be made by Glaxo Group Limited or one of its affiliates pursuant to its agreements with Innoviva, Inc. relating to certain drug development programs, including the combination of fluticasone furoate, umeclidinium, and vilanterol (the Closed Triple), currently in development for the treatment of COPD and asthma.

Company info
Website
Phone
650-808-6000
Location
901 Gateway Boulevard
South San Francisco
California
94080
US

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