Jobs Available (7/20/10)

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The following   jobs have been posted recently:

July 20th, 2010

Exelixis: Interested applicants can send the CVs to linguyen@exelixis.com or apply on line at www.exelixis.com; job ID # 997

Position Description  

Collaborate with leading Scientists to characterize pharmacokinetics and pharmacodynamics properties of drug candidates in development stage. Provides technical support to enable Pharmacokinetics/Toxicokinetics (PK/TK) analyses by performing non-compartmental and compartmental analyses to support Investigational New Drug (IND) enabling toxicology studies, and clinical studies and to facilitate clinical development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Functions as a contributing scientist or a principle investigator to write TK/PK reports or other documentation such as Investigational New Drug (INDs), Investigational Medicinal Product Dossier (IMPD), Clinical Trial Application (CTA) and Investigational Brochure (IBs) to support regulatory fillings.
• Assists with designing clinical studies (Phases 1-3 studies).
• Contributes to the preparation and delivery of presentations, protocols, clinical study reports which contain the PK/TK components.
• Collaborates with colleagues within non-clinical development, and in biostatistics and other clinical groups to facilitate the timely preparation and transfer of datasets containing PK/TK and/or patient demographic data for analysis.
• Works closely with leading scientists to draft Standard Operating Procedures (SOPs), guidelines and software validation to support PK/TK related work.
• Proficiency with PK software e.g. WinNonlin is required; familiarity with NONMEM is a plus.
• Strong written and verbal communications skills are a must.

 

Education:
• MS/MA degree in related discipline and 3-5 years of related experience; or
• PhD degree in related discipline and 0-2 years of related experience;

Experience:
• Typically requires a minimum of seven-eight years of related experience and/or combination of experience and education/training.

Knowledge/Skills/Abilities:
• Experience with fundamental knowledge and proficiency in the theory and application of PK and PK/PD data modeling, analysis and simulation of small molecules
• Hands-on experience in WinNonlin and Sigma Plots softwares
• A good understanding of drug metabolism, biopharmaceutics and bioanalytical principles
• Excellent written/oral communication skills, interpersonal/influencing skills, and ability to work in continually changing environment

 

May 25, 2010,

Genentech.

Clinical Pharmacology Specialist/Scientist

Responsibilities:

Genentech is looking for a talented Clinical Pharmacology Specialist/Scientist to be responsible for overall planning, management, data evaluation and reporting of clinical pharmacology studies. He/she will lead protocol development and participates in study management as the primary clinical pharmacology representative. The incumbent will also provide clinical scientific input for final study reports and annual report documentation and assist the CP in high-level IND and NDA documentation process.

The individual will lead the evaluation of clinical pharmacology data (pharmacokinetics, pharmaco-dynamics, safety), interacting as required with operational staff and investigators, Data Management, Biostatistics and other partners. He/she will also be responsible for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, CRF and protocol amendments.

Requirements:

This position requires a PhD, PharmD, MD or equivalent scientific qualification in Pharmacology or related discipline with 3-8 years of working experience. The successful candidate must have a working knowledge of various approaches to PK and PD data analysis: compartmental, curve-fitting, non-compartmental. Proficiency in the population data analysis is a plus. The ideal applicant will have appropriate computer software experience e.g., MS Word, Excel, PowerPoint, WinNonlin. Knowledge of Splus, Spotfire and NONMEM. Clinical research experience, preferably in the pharmaceutical industry, with an overall knowledge of ICH GCP and the drug development process is vital. He/she must have experience of working on and preferably leading a team matrixed around the scientific and/or clinical study-related tasks. The individual must have excellent communication and interpersonal skills

. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. # 1000032943. Please use “Web – BAADME” when a source is requested. Genentech is an equal opportunity employer.

 

February 12, 2010.

Nektar Therapeutics

Sr. Research Associate – (San Carlos, CA)

Position Summary
As a key member of the Research in vitro biology group, the candidate is responsible for evaluation of Nektar’s proprietary PEGylated molecules in diverse therapeutic areas.  Performs research and/or development in collaboration with others for projects. Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies.  Contributes to projects within a scientific discipline. Maintains a high level of professional expertise through familiarity with scientific literature. May participate in scientific conferences and contribute to scientific journals.

Requirements
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years work experience in a research and/or development environment is required. The candidate will be responsible for conducting biochemical assays to characterize the metabolism of Nektar’s proprietary small molecule conjugates. Prior experience working with hepatocytes, microsomes and isolated enzymes is preferred. Experience in sample bioanalysis using LC-MS/MS systems is desirable. Must have excellent analytical skills, with significant hands on laboratory experience. Must have a demonstrated working knowledge of scientific principles.  Must be able to demonstrate good decision-making skills. Must possess excellent oral and written communication skills. Must be able to independently write reports. Must be able to demonstrate sound judgment within broadly defined practices and policies. Must have demonstrated problem solving abilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Experience working in an FDA regulated environment is highly desired. Must be able to work well in and promote a team environment, and demonstrate leadership abilities. Must be able to provide technical assistance to others in a wide range of laboratory based activities/techniques.

If interested, please email your resume to mmerrill@nektar.com or apply online at www.nektar.com

 

October 10, 2009:

Head of ADME- DMPK, Genentech

Responsibilities:

The department of Drug Metabolism and Pharmacokinetics (DMPK) at Genentech Research and Early Development in South San Francisco is seeking a highly motivated Associate Director with proven abilities in the small molecule pharmacokinetics and metabolism field to lead a team of experienced and talented ADME Scientists. This individual will work closely with colleagues in other department on projects ranging from early to late stage discovery and up to proof of concept in the clinic. Close interactions and collaborations with peers within DMPK to ensure optimum prosecution and progression of projects and impact of collective ADME data on projects will be essential for this position. Working with senior management, The individual will use his/her scientific expertise and insights to weigh in on strategic decision making regarding the portfolio, compound nomination for development and how to prosecute compounds in development. The individual will be a strong advocate of incorporating the latest science and technology to optimize the drug discovery and development process and ensuring that ADME properties are effectively incorporated in lead identification, lead optimization and development.

 

Requirements:

A PhD in Pharmacokinetics, Drug Metabolism or other relevant fields such as Pharmaceutical, Biological or Chemical Sciences and at least 10 years of industrial experience will be required. Extensive experience leading DMPK teams in support of drug discovery and preclinical and clinical development is required. In depth knowledge of small molecule ADME is required and experience with human PK prediction and PK/PD modeling is highly desirable. Extensive scientific track record (publications, presentations, etc.) is required and excellent communication and interaction skills exemplified in discovery project teams and development teams are essential. Experience with regulatory filings and FDA interactions is highly desirable. In addition, a successful candidate should be a courageous leader with experience of mentoring a group of at least 15 BS/MS/PhD scientists. The following competencies are required as well:

·        Ability to make (strategic & tactical) decisions in ambiguous situations

·        Ability to drive innovation and implement changes

·        Ability to identify and deliver goals for department

·        Ability to build strong relations with partner lines (chemistry, in vivo & biochemical pharmacology, pharmaceutical sciences, toxicology, clinical PKPD, etc.); role model for collaboration and teamwork

·        Excellent interpersonal, communication and supervisory skills

 entech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. #1000028237. Please use “Web – BAADME” when a source is requested. Genentech is an Equal Opportunity Employer.

October 7th, 2009:

Associate Director, DMPK. Theravance.

Job Purpose

As a member of the Drug Metabolism and Pharmacokinetics (DMPK) team, the successful candidate will be responsible for supporting in vivo bioanalysis of blood and tissue samples from various pre-clinical species by LC-MS/MS. Additional responsibilities include in vitro DMPK efforts by performing metabolism and protein binding studies.  The ability to manage work independently while working effectively in a team is required. The candidate will also be responsible for presentation of data at Department meetings, data analysis and maintaining accurate documentation of studies.  The successful candidate will be highly motivated with excellent organizational and reporting skills and will help support drug discovery in the DMPK department. 

 Duties and Responsibilities

 Sr. Scientist, DMPK. Theravance.

 Applications

Applicants should possess a BS in Chemistry/Biology or related coursework and 2-5 years of relevant experience. Prior experience with in vivo bioanalysis and LC-MS/MS is a requirement.  Prior experience with in vitro DMPK assays, metabolite identification, GLP and robotics is a plus.  The candidate must be able to analyze data and note significant deviations and maintain detailed, accurate and comprehensible study documentation. Successful applicants will have excellent oral and written communication and organizational skills. 

Job Purpose

The Drug Metabolism and Pharmacokinetics (DMPK) department at Theravance is seeking an experienced, laboratory-based research associate to support small-molecule drug discovery and development. Primary responsibilities will be the design and implementation of mechanistic investigations into the pharmacokinetic and drug disposition properties of drug discovery and development candidates.  The position requires a solid background and understanding of drug metabolism, drug-metabolizing enzymes, drug transporters, drug-drug interactions, and bioanalytical techniques. The successful candidate will exhibit strong communication and interpersonal skills and exhibit a desire to work in a flexible and dynamic environment.

 Duties and Responsibilities

Qualifications

 

 

Interested applicants should send their resume to resumes@theravance.com

 

September 15th, 2009

Associate Director, Drug Metabolism & Pharmacokinetics

Location: Cambridge , MA

The Associate Director, Drug Metabolism & Pharmacokinetics will be responsible for overseeing the efforts directed at understanding the metabolism and biological fate of our drug candidates to support our global drug discovery and development strategies. This includes managing and hands-on contributions to the development of in vitro ADME assays (i.e. CYP inhibition, CYP induction, reactive metabolite profiling) as well as the translation of these observations into an understanding of in vivo metabolic fate.  The individual will be responsible for leading our strategy in deciphering the in vivo biotransformations of our drug candidates, from pre-clinical animal models through the clinic.  The selected individual will work closely with other scientists and disciplines (pharmacology, chemistry, pharmaceutical development, toxicology and clinical) to analyze and interpret the resulting biotransformation and metabolism data and plan the path forward. The candidate will also be expected to work independently while effectively mentoring and supporting the development of team members.

Position Requirements

·    Degree in Chemistry, Analytical Chemistry, Biochemistry, Biology, Pharmacology or related field; Ph.D. with a minimum of 8 years industry experience.

·    Experience with leading the drug metabolism studies required to support drug candidate selection, IND enabling studies and first-in-man investigations.

·    Must have extensive experience in small molecule structural elucidation and thorough understanding of biotransformation pathways and processes.

·    Hands-on experience with hepatocytes is strongly desired.

·    Strong analytical skills including methods development as well as operation and maintenance of analytical hardware (HPLC, mass spectrometers) required, as well as the use of associated data processing software (e.g. Analyst, MetaboliteID).

·    Strong interpersonal and leadership skills; passion for staff development and mentorship.

·    Experience with outsourcing studies and evaluating external reports from contract research organizations is desirable.

·    A sound understanding of pharmacokinetics and drug disposition is desired.

·    Must have good writing and communication skills, attention to detail, and strong problem-solving skills, as well as the ability to work in a multidisciplinary team environment and present their work at departmental meetings.

 

Infinity offers an outstanding benefits package and is a EOE. Interested applicants can apply on-line at www.infi.com.

 

If you would like to post an open position on this website please send an e-mail to:

 member@baadme.org

Please include:

your name, company, position description, position requirements

and means of contact to inquire about the position

Thank you!


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