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Lantheus

Executive Director Biostatistics

Bedford, MA · On-site

The Executive Director will serve as the project-level biostatistician, providing expertise in the ... Typically, 20+ years of experience in the pharmaceutical industry or CRO with at least 10 years in ...

Lantheus

Executive Director Biostatistics

Bedford, MA · On-site

The Executive Director will serve as the project-level biostatistician, providing expertise in the ... Typically, 20+ years of experience in the pharmaceutical industry or CRO with at least 10 years in ...

Madrigal Pharmaceuticals, Inc.

Role Summary The Executive Director, Operations Lead is accountable for the management of clinical ... Participate in proposal review meetings for CRO selection. * Review and collaborate to negotiate ...

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Executive Director, DMPK

Exton, PA • On-site

Frontage Laboratories
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees
Learn more about Frontage Laboratoriesexternal

Full-time

Re-posted 20 days ago

Job description

Title: Executive Director, DMPK

Location: Exton, PA

Reports to: VP, DMPK

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

The successful candidate will lead the in vitro ADME and pharmacokinetic functions of the DMPK department at the Exton, PA site. The position involves overseeing a group of approximately 20 scientists performing studies to evaluate the pharmacokinetics, drug metabolism and drug-drug interaction potential of development and discovery-stage drugs.

The successful candidate will be responsible for setting performance and financial goals for the business unit and ensuring the required resources/personnel are in place to achieve the goals.

Roles & Responsibilities:

  • Keep abreast of new scientific developments and regulatory requirements and ensure the work within the group is performed accordingly
  • Have a general strategy of soliciting business, meet customers and provide scientific input so that the right studies are performed to address the scientific and/or regulatory question at hand
  • Design studies as needed and include in study proposals /protocols
  • Prepare study proposals at the request of customers
  • Provide guidance in the preparation of study protocols for in vitro and in vivo studies
  • Help with the interpretation of data and conclusions/summaries for completed studies
  • Ensure that all studies are conducted efficiently and in a timely manner while maintaining highest quality of data
  • Ensure that the scientists follow Frontage SOPs, DMPK guidelines, and study protocols while conducting studies
  • Other duties as assigned

 Education, Experience & Skills Required:

  • PhD in chemistry, biology, or related area
  • More than 10 years of related experience in the biotech, pharma or preclinical CRO industry
  • Solid knowledge of in vitro DMPK, drug transporters, enzyme kinetics and pharmacokinetics
  • Familiarity with bioanalysis using LC/MS/MS
  • Experience with drug discovery and development and the toxicology, drug metabolism, and pharmacokinetics data required at various stages of the drug discovery and development process
  • Good track record in leading small to large DMPK groups  

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.