Shire Clinical PK and PK/PD Leader in Lexington, Massachusetts
Responsible for providing strategic and operational clinical pharmacokinetics/pharmacodynamics support to project teams. Also provide clinical PK/PD expertise to support the development, registration and commercialization of Shire’s products from before first-in-human studies and throughout the product lifecycle.
Design clinical pharmacology/PK programs to support the development, registration and commercialization of Shire’s products.
Ensure programs comply with regulatory authority and legal requirements
Ensure programs generate the information needed to conduct a thorough human risk assessment (appropriate for the stage of clinical development)
Involve other Shire staff and external specialists as necessary
Agree programs of work and budgets with the VP Clinical Pharmacology and relevant Project Teams
Provide support for publication strategies
Provide support to Legal on patent and intellectual property issues
Select on merit suitable Contract Research Organisations (CROs) and academic centers to carry out programs of work and to establish collaborations with key consultants
Ensure appropriate contracts and procedures are in place to protect Shire’s intellectual property and reputation
Ensure adequate resources and expertise are assigned to enable timely completion of the work
Agree on detailed study protocols with contractors
Monitor programs of work to ensure compliance with agreed protocols, quality standards and timelines
Review data in a timely manner and amend protocols as necessary to achieve best outcome
Ensure a high quality report, suitable for regulatory submission, is produced for each study
Involve other internal and external specialists as necessary to interpret findings and assess relevance for use in man
Provide clinical PK and human drug metabolism expertise to Project Teams and Shire management across projects
Provide the clinical pharmacokinetics and pharmacodynamics expertise and support required for Investigator Brochures, Clinical Trials Applications, Marketing Applications, regulatory meetings, and responses to regulatory questions.
Agree the clinical pharmacology documentation plan for each submission with the Project Team and VP Clinical Pharmacology. Agree timelines and how the work is to be resourced.
Participate in the writing, compilation and review of the dossier to agreed timelines.
Identify potential in-licensing opportunities; review data packages, and present recommendations to Shire management.
Supervision and monitoring of external consultants and staff at Contract Research Organisations (CROs) contracted to work for Shire.
Utilize expertise in drug development, clinical pharmacology and clinical pharmacokinetics to proactively support the development and growth of Shire’s Global Clinical Pharmacology & Pharmacokinetics organization.
A PharmD or PhD from an accredited college or university in clinical pharmacology, pharmaceutics, clinical pharmacokinetics or biopharmaceutics or closely related field and at least 12 years experience in the Pharmaceutical Industry working in clinical pharmacology, clinical pharmacokinetics or drug metabolism. An individual with an MS degree in one of the above areas could also be considered based on their skill level and previous experience.
Demonstrated ability to successfully manage the clinical pharmacology/pharmacokinetic components of multiple drug products across all phases of development
Demonstrated ability to successfully manage clinical pharmacology and pharmacokinetic aspects of regulatory agency interactions and label negotiations
Demonstrated ability to successfully manage internal staff and external consultants/vendors
A sound knowledge of clinical pharmacology and clinical pharmacokinetics. Expertise in PK/PD modeling and Population PK is also desirable
A sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products
A sound knowledge of GCP regulations and familiarity with GLP and GMP requirements
A sound knowledge of the drug development process, and a detailed understanding of non-clinical and clinical DMPK processes
A sound working knowledge of the cross-functional interfaces that are important for efficient drug development
A sound working knowledge of regulatory documentation requirements
Ability to present complex issues in oral and written form
Ability to work independently, take initiative and complete tasks to deadlines
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
Excellent interpersonal, communication, analytical, and organizational skills
Proven ability to work within and motivate cross-function teams
Ability to effectively present information to management, external contractors and employees at all levels of the organization
Other Job Components
Travel expected to be approximately 20% and will be both US and international.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.