Job Title Senior Director, Clinical Pharmacology
Req ID 6319BR
Department Clinical Pharmacology
Location Boston, MA
Job Description
The Head of Clinical Pharmacology provides
strategic vision, scientific leadership and professional management to the Clinical
Pharmacology department. She/he provides expertise in clinical pharmacology
supporting assessment of pharmacokinetics, absorption, distribution,
metabolism, and excretion (ADME), and drug-drug interactions of Vertex
portfolio compounds in humans across the full spectrum of drug development. She/he collaborates with other key functions,
including Modeling & Simulation, Clinical Biomarkers, Clinical Development,
Regulatory, CMC and Preclinical Development to maximize efficiency in drug
development programs and to minimize risk of late stage failures.
Key Responsibilities
•
Supervise and provide scientific
leadership in clinical pharmacology to support effective development of Vertex
portfolio compounds with respect to clinical pharmacokinetics and intrinsic and
extrinsic factors that impact ADME properties of a compound.
•
In close collaboration with
Departments of Modeling & Simulation and Clinical Biomarkers, supervise
preparation and execution of clinical pharmacology plans to ensure an
integrated translational medicine approach for each drug development program, from
early development and first-in-human through life cycle management.
•
Collaborate with Drug Metabolism
and Pharmacokinetics and Pharmaceutical Development to ensure an integrated and
efficient approach to evaluating drug-drug interaction potentials and biopharmaceutics
in support of clinical drug development.
•
Provide strategic
direction to the writing and review of clinical protocols, clinical study
reports, Clinical Pharmacology and Biopharmaceutics Summary documents, meeting
background packages, and other documents submitted to regulatory authorities
•
Interacts with regulatory
agencies and advisory committees as appropriate.
•
Participate in due
diligence efforts of Vertex business development
•
Manage department level
budget and resources
•
Establishes close
connections with key opinion leaders and academic groups within the clinical
pharmacology community to secure continued growth of expertise within the Clinical
Pharmacology Department at Vertex.
•
Contributes to the
overall drug development strategy and operation by collaborating with other
functions and key decision makers.
•
Mentor
individuals in the Clinical Pharmacology Department and establish a continuous
learning environment to allow talented scientists to grow in accordance with
Vertex business needs.
Minimum Qualifications
Required Qualifications
•PhD in pharmacology/pharmaceutics or MD, MD/PhD, Pharm D with training in clinical pharmacology.
•10+ yrs hands-on experience in the application of clinical pharmacology within the context of drug development.
•Prior experience in leading group.
•Expert knowledge in pharmacokinetics, drug-drug interactions, bioavailability/bioequivalence, special populations, QTc assessment, and dose selection
•Extensive knowledge of the drug development process
•Demonstrated direct and strong experience in interactions with regulatory authorities and good insight into regulatory guidelines and expectations with respect to clinical pharmacology support in drug development (e.g. IND/CTA, EOP2 meeting, Scientific Advice, NDA/MAA etc).
•Direct experience with model-based drug development and the application of translational approach
•Knowledge of current practices and issues in bioanalytics, biopharmaceutics, pharmacology, and toxicology
•Excellent oral and written communication skills.
•A demonstrated ability and aspiration to collaborate with colleagues within and outside own discipline to reach a common goal.
Desirable qualifications
•Experience in matrix team leadership within the context of drug development
•Clinical pharmacology experience in disease areas such as pulmonary diseases and oncology
Company Information
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia.For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.