We are seeking a dedicated, self-motivated, marketing professional for the position of Brand Marketing Manager within the marketing function of this growing biotech company. The primary role of this dynamic position is to lead the development and coordination of the promotional strategy (in collaboration with co-promotion partner) including brand positioning, customer segmentation, market research strategy and implementation of launch tactics.

• developing comprehensive plans for product strategy, including development of plans and translation of those plans to specific marketing tactics, tactical implementation with projects such as the development of a new marketing campaign and core visual aids, and budget management of specific projects within the brand budget and making compromises and adjustments throughout the year based on changing priorities and market opportunities;
• driving the tactical execution of the pre-launch promotional plan, including development of sales materials;
• providing strategic and tactical input into development of a robust launch plan;
• managing all inputs and commercial needs for "Review Team" or a version of this team which approves selling messages and materials;
• managing agency relationships including creative agencies, medical communication companies, media advertising and planning companies, web development companies, meeting planning companies, print and production companies;
• ensuring that all programs are planned and conducted in accordance with company guidelines, team timelines and budget constraints;
• staying up to date on the changing compliance, CME, regulatory environment, and associated protocols;
• proven experience selecting, developing and evaluating personnel to ensure the efficient operation of the function; and
• influencing the direction of the brand within the context of an alliance with a large pharmaceutical company.

Requirements:
BA/BS degree (MBA preferred) with two to four years of pharmaceutical product management experience; CNS experience is a plus. Strong strategic thinker, i.e., ability to formulate and develop complex commercial strategy. Experience working in or with sales and sales management experience, with product life-cycle management and with outside advertising and creative agencies. Strong interpersonal skills with ability to lead, focus, interact with, and resolve conflict and drive consensus among individuals from a variety of cultures and disciplines. Strong communication and presentation skills, e.g., efficiently and productively communicate orally and in writing, with ability to convey brand strategy and tactical implementation steps with confidence, passion and conviction. Proven task management skills, including planning, prioritization, objective setting, meeting management and plans execution.

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We are seeking a highly motivated and energetic individual to become a member of the business development team. The candidate will play a primary role in the identification, evaluation and assessment of new licensing and business opportunities for XenoPort.

• evaluation of possible partnership/M&A opportunities by performing financial, market and strategic analyses to assess the fit with XenoPort;
• attending business development and/or relevant medical/scientific meetings to search for business/scientific opportunities aligned with corporate interests;
• developing and maintaining strong external relationships and communication with potential collaborators;
• supporting business development activities through licensing/company screens, due diligence, corporate visits, written communications and contract negotiations; and
• researching and analyzing secondary market research to provide support for business development, strategic and possible M&A activities.

Requirements:
An MBA, and a BS in Science (biology or chemistry preferred), Finance, or Marketing. An advanced science degree (MS, MD, PhD) is preferred. Five to seven years of total health care experience with at least one to two years within business development, strategic marketing, investment banking or consulting. A minimum of two years related work experience performing financial and strategic analyses is required. Excellent communication and presentations skills. Proficient in Microsoft Excel, Word and PowerPoint. Experience or training in CNS diseases is preferred but not required.

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We are seeking a dedicated, self-motivated professional for the position of HelpDesk Technician within the IT group of this growing biotech company. The Help Desk Technician’s role is to ensure proper computer operation so that end users can accomplish business tasks. This includes receiving, prioritizing, documenting, and actively resolving end user help requests. Problem resolution will involve the use of diagnostic tools and utilities, remote control software and help request tracking tools, as well as require that the individual give in-person, hands-on help at the desktop level.

• fielding incoming help requests from end users via telephone, e-mail and help request formats in a courteous manner;
• obtaining and documenting pertinent end user information, nature of problem and location of issue;
• building rapport and eliciting problem details from help desk customers;
• prioritizing and scheduling problems;
• escalating problems (when required) to the appropriately experienced technician;
• recording, tracking, and documenting the help desk request problem-solving process;
  • include successful and unsuccessful decisions made, and actions taken, through final resolution
• creating and maintaining helpful documentation for our internal knowledgebase within Footprints to produce guided examples to end-users for self resolution of common issues;
• applying diagnostic utilities to aid in troubleshooting;
• accessing software updates, drivers, knowledge bases, and frequently asked questions resources on the Internet to aid in problem resolution;
• identifying and learning appropriate software and hardware used and supported by the organization, in particular, Numara Footprints help desk software;
• testing fixes to ensure problem has been adequately resolved;
• evaluating documented resolutions and analyzing trends to prevent future problems;
• seeking to improve existing documentation and or procedures;
• developing help sheets and frequently asked questions lists for end users;
• helping to develop and maintain IT intranet content for end users.

Requirements:
Working knowledge of basic computer hardware, including Dell laptops and desktops, HP printers, and Treo mobile devices. Experience with desktop operating systems, including Windows NT, 2000, XP, Vista, and Windows server operating systems, including 2000 and 2003. Familiarity with applications and utilities such as; Microsoft Outlook and Remote Desktop Protocol (RDP), Symantec Ghost and Active Directory utilities, such as Hyena, Remote support tools (Microsoft Remote Assistance and GoToAssist). Experience providing remote support for end users. Experience configuring wireless clients. Strong written and oral communication skills. Keen attention to detail with strong documentation and administration skills. Ability to conduct research into a wide range of computing issues as required. Ability to absorb and retain information quickly. Ability to present ideas in user-friendly language. Highly self motivated and directed. Proven analytical and problem-solving abilities. Ability to effectively prioritize and execute tasks in a high-pressure environment. Experience working in a team-oriented, collaborative environment. College degree or equivalent work experience. Microsoft, Cisco, Juniper, HP certifications desirable.

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We are seeking a dedicated, self-motivated marketing professional for the position of Senior/ Medical Marketing Manager within the marketing function of this growing biotech company. The primary role of the position is to manage and coordinate Medical Marketing activities for all products in development & related therapeutic areas. This includes leveraging a broad skill set to positively impact a dynamic environment by coordinating all key opinion leader (KOL) activities with prioritization & integration into XenoPort's scientific, clinical and commercial activities; managing scientific communications development & dissemination process to meet broad corporate objectives; and building a knowledge management foundation to inform strategic business decisions.

• leading the development and execution of KOL relationship management plans, to support the clinical development and commercialization needs in all key therapeutic areas;
• leading in the development and execution of all advisory and consultant meeting activity;
• working in collaboration with Business Development to identify experts for assessment of new licensing compounds or therapeutic areas of interest;
• defining market research needs and securing insights from research and analytics to direct strategies and optimize tactics;
• driving the development of KOL selection criteria and use of influence mapping tools for objective identification of KOL expertise into activities such as consultants boards, investigators for research, public relations, publications, activities at medical congresses, life cycle planning, speakers bureaus and health care systems for KOLs in the US and globally;
• managing the communications development process to maximize the impact & dissemination of scientific and clinical data to prepare markets for commercialization and to effectively educate healthcare professionals;
• leading cross-functional and cross-partner teams to develop strategic plans, collaborating with clinical scientists to execute plans, and managing relationships with communications agencies providing tactical support while practicing company and industry best practices;
• coordinating the development of medical education programs, including speaker programs, symposia and community meetings for relevant healthcare professionals;
• employing therapeutic area expertise and product knowledge to strategically guide decisions and activities surrounding product launches and to train Medical Science Liaisons, and selecting, developing and evaluating personnel to ensure the efficient operation of the function; and
• influencing the direction of the medical marketing effort within the context of an alliance with a large pharmaceutical company.

Requirements:
Bachelor's degree required, PharmD/PhD/Masters/MBA degree preferred; CNS is a plus. Position requires at least four to six years of overall pharmaceutical business experience which should include demonstrated marketing management, medical/scientific liaison roles, and/or other related technical expertise. Prior management experience preferred. Travel ability approximately 35%. Strong interpersonal skills and demonstrated relationship management experience with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines. Strong communication skills with an ability to efficiently communicate both orally and in writing. Proven task management skills to include planning, prioritization, objective setting, meeting management and plans execution.

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We are currently seeking an individual to become a member of our growing team. The individual will lead the management of serious adverse events and provide pharmacological safety expertise within and outside the Integrated Product Safety group.

• Be responsible for the management of Serious Adverse Events:
  • Develop safety management plans with CROs
  • Manage serious adverse event reports from receipt to reporting (seriousness, expectedness, completeness, clarity, follow-up), and liaise with the Medical Director and with Regulatory Affairs
  • Ensure compliance with internal policies and global regulatory requirements
  • Provide reports and listings as needed
  • Lead the reconciliation between the safety and the clinical database
• For Adverse Events (serious and non-serious), lead the process for coding using dictionaries such as MedDRA and WHOART and liaise with Medical Directors for the coding of adverse events.
• Lead the exchange of safety data with our partners according to signed agreements.
• Based on XenoPort strategy including portfolio development and alliances, propose a plan for capturing Serious Adverse Events electronically in a validated database and, once agreed, implement it.
• Provide pharmacological safety expertise for early phase clinical safety studies such as renal-impairment studies, hepatic-impairment studies, drug-drug interactions and cardiotoxicity studies.
• Collaborate with other departments on product safety issues, as appropriate.
• Provide input and/or participate in review of clinical study protocols, reports and other regulatory documents as needed, with an emphasis on the safety sections.
• Participate in internal and external safety trainings.

• Advanced Health Professional degree, Pharm.D. preferred.
• Knowledge of global regulatory requirements regarding drug safety.
• Experience in pharmaceutical medicine, drug development and/or drug safety
• Strong problem-solving and analytical skills
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.

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We are currently seeking an individual to become a member of our growing team in providing medical safety monitoring to clinical teams involved in all phases of clinical development. As product development reaches commercialization, the Medical Director will also support pharmacovigilance of marketed compounds in the future.

• working closely with the Clinical Sciences and the Clinical Operations groups in development of clinical strategies, development plans, study protocols, and clinical trial related documents, especially as it pertains to drug and clinical safety;
• actively supporting clinical trials by participating in study start-up meetings and other activities to provide the appropriate medical safety training and information to investigators and site personnel;
• actively supporting clinical trials by ensuring appropriate communication of risks to subjects, reviewing informed consent documents for study initiation and conduct to ensure medical accuracy and compliance with GCP and regulatory requirements;
• actively supporting clinical trials by monitoring patient safety during conduct of studies and advise study teams of proper patient care to protect patient safety;
• actively supporting clinical trials by addressing any questions and resolving safety-related issues arising during the conduct of studies, with direct interface with partners and investigators;
• reviewing adverse events and safety assessments data, participating in safety data analysis and identifying safety signals, and as appropriate, help assure initiation and completion of appropriate actions;
• leading the medical analysis and review of SAEs and AEs of interest;
• leading the preparation of safety documents such as position papers, CSI, SMP and RMP;
• ensuring clear and timely internal communication of safety issues with product teams;
• providing medical safety expertise during to the preparation of reports or documents such as IB, CSR, Annual Report, IND, NDA, or ISS; and
• establishing and maintaining contacts with external safety and pharmacovigilance experts, opinion leaders, and the general medical community.

Requirements:
Medical Doctor or Doctor of Osteopathy degree; training and board certification in internal medicine recommended. Minimum three years experience in clinical practice, clinical research and pharmaceutical medicine, and the drug development process relevant to the U.S. Experience in clinical trial safety monitoring is preferred. Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.

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We are seeking a dedicated, self-motivated professional for the position of Purchasing Agent/Buyer within the Materials Management group of this growing biotech company. The primary role of this dynamic position is to manage all components of the procurement process.

• creating purchase orders from approved requisitions and blanket purchase orders for services and contracts;
• interacting with requestors to order details and terms;
• contacting suppliers to place and confirm orders;
• obtaining supplier quotations for goods and services and negotiate for cost reductions and favorable terms;
• purchasing activities including supplier selection and negotiations with suppliers for price, quality, timeliness of delivery, specifications, value improvement programs, contract administration, requisition review and purchase order execution;
• maintaining a working knowledge of market conditions and advising management on purchasing alternatives to assure a continued flow of materials to meet production and sales requirements;
• understanding the Fixed Asset Management process.

Qualifications and Other Required Knowledge and Skills:
Requires BS in Business, Materials Management or related field. Minimum of three years experience in a purchasing and/or materials environment. Effective negotiations, persuasion and communications skills. Must be able to work independently and have organizational communication and problem solving skills.

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We are currently seeking talented individuals with expertise in process development of solid dosage formulation to join our growing Pharmaceutical Development team.

• Develop robust, stable, and bioavailable formulations to support Phase II and III clinical studies and commercialization.
• Develop and scale-up robust processes for the production of solid dosage formulations.
• Identify and collaborate with CROs/CMOs in the execution of clinical batches, and scale-up of formulation and processes to support late phase clinical studies and commercialization.
• Identify and develop platform technologies for sustained release formulations.
• Collaborate with QA and Analytical functions towards timely generation of regulatory documents.

• A BS/MS/PhD in Chemical Engineering, Chemistry, Materials Science or Pharmaceutical Sciences is required, with 10+/6+/3+ years of related industry experience in formulation design and development and process development and scale up.
• An in-depth knowledge and research expertise in the field of solid oral dosage formulation is strongly desired, from conception to full commercial utility.
• Strong knowledge of roller compaction and/or fluid bed granulation required.
• Working knowledge of sustained release formulations preferred.
• Familiarity and working knowledge of GMP/ICH regulations required, with experience working in a GMP facility preferred.
• Ability to work independently, with excellent organizational, communication, leadership and problem solving abilities.
• Working knowledge of quality by design and risk management is strongly desired. Knowledge of ICH Q8/Q9 and Q10 is preferred.

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We are current looking for an energetic and talented analytical chemist to join our Analytical Chemistry team. The successful candidate will be a key team member utilizing advanced analytical instrumentation and techniques, such as HPLC/UV/PDA/ELSD, LC/MS/MS, GC/MS, NMR, to forward our exciting drug candidates. This newly created position will report to the leader of the Analytical Research group within Analytical Chemistry.

• technical leadership in the isolation, structural elucidation and quantification of drug impurities and degradation products;
• performing and developing Mass Spectrometric, Chromatographic, NMR and other analytical techniques to provide full characterization of unknown small molecules;
• writing technical procedures, technical reports and documents in support of our drug development projects;
• optimizing techniques and identifying and implementing new technologies to enhance Analytical capabilities, (for example CE, SFC) with regard to the isolation, monitoring and identification of drug impurities and degradation products;
• performing physical characterization of drug candidates (pH, pKA, solubility) as part of preformulation support;
• managing multiple projects with minimum supervision and meeting internal and external client timelines with respect to data and reports;
• interacting productively with colleagues on multidisciplinary drug development project teams to achieve project goals. Working on complex problems where analysis of situations or data requires an in-depth evaluation of many factors;
• sustained demonstration of leadership qualities in technical proficiency, scientific creativity, collaborations with others and independent thought;
• demonstrating commitment and enhanced efficiency in quantity and quality of work
• maintaining familiarity with scientific literature. Possesses intellectual mastery in Analytical Chemistry.

The ideal candidate should have a PhD or MS degree with at least five - ten years of relevant experience in GMP analytical method development/validation and ICH stability testing within the pharmaceutical industry. Expertise in HPLC and detector technology (such as UV, ELSD, RI or MS detectors), in modern data acquisition and in handling software is essential. Experience in development of IVIVC dissolution methods for IR/CR tablet formulations would be a plus. Good documentation, people management and communication skills will be required. Prior experience with analytical development for commercial or late-stage

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We are currently seeking talented individuals with experience developing or leading an organization responsible for API and finished dosage form product and process characterization in a Research & Development environment to join our growing Pharmaceutical Operations team.

• identifying, developing, implementing, maintaining and providing oversight for scientific and logistical activities specific to characterization of API and finish dosage forms for development programs;
• contributing to the development and implementation of procedures/guidances for associated characterization methods and in-house laboratory operations;
• providing comprehensive oversight of CRO/CMO data generated on the behalf of XenoPort in cGMP laboratories;
• ensuring outputs from Analytical Development are generated in context of cGMP expectations;
• collaborating with others on basic research and development plans relevant to long-term objectives;
• contributing to leadership team for development activities specific to Pharmaceutical Operations (analytical, formulation and chemical development functions);
• identifying and developing a work environment that supports appropriate employee development specific to increasing the depth and breadth of Analytical Development;
• providing organizational management to 15-20 scientists; provides resource planning and manages recruiting initiatives to execute to the plan;
• high-level participation in project planning and departmental budgeting, including identifying, implementing and accountability for capital and service budgets to support group functions; and
• providing content oversight for document generation of CMC source documents to support IND/aIND/AR/NDA regulatory submissions.

Requirements:
A PhD with ten plus years of related experience in Analytical/Physical Chemistry is required, with related industry experience in a cGMP environment. A solid publication record is a strong plus. A strong scientific understanding and expertise in the field of characterization science to support API and product development, from conception to full commercial utility, is required. A strong knowledge of current industry and regulatory trends in regard to science based approaches to developing pharmaceutical products and processes. Ability to work independently, think creatively, with excellent organizational, written and oral communication, leadership and problem solving abilities. A demonstrated track record of organizational management and development, organizational effectiveness is strongly desired. A demonstrated track record of project management with focus on facilitative and organizational skills.

For application information, click here

We are currently seeking talented individuals with experience in an organization responsible for API and finished dosage form product and process characterization in a Research & Development environment to join our growing Pharmaceutical Operations team.

• identifying, developing and implementing scientific and logistical activities specific to characterization of API and finish dosage forms for development programs;
• contributing to the development and implementation of procedures/guidances for associated characterization methods and in-house laboratory operations;
• providing oversight of CRO/CMO data generated on the behalf of XenoPort in cGMP laboratories;
• ensuring outputs from Analytical Development are generated in context of cGMP expectations;
• collaborating with others on basic research and development plans relevant to long-term objectives; contributes to the working team for development activities specific to Pharmaceutical Operations (analytical, formulation and chemical development functions);
• having a proven track record of employee development specific to increasing the depth and breadth of Analytical Development;
• providing organizational management to 5-8 scientists; provides resource planning and manages recruiting initiatives to execute to the plan;
• contributing to project planning & budgeting to support group functions;
• providing content oversight for document generation of CMC source documents to support IND/aIND/AR/NDA regulatory submissions.

Qualifications and Other Required Knowledge and Skills:
A PhD with 8+ years of related experience in Analytical/Physical Chemistry is required, with related industry experience in a cGMP environment. A solid publication record is a strong plus. A strong scientific understanding and expertise in the field of characterization science to support API and product development, from conception to full commercial utility, is required. A strong knowledge of current industry and regulatory trends in regard to science based approaches to developing pharmaceutical products and processes. Ability to work independently, think creatively, with excellent organizational, written and oral communication, leadership and problem solving abilities. A demonstrated track record of people management and development is strongly desired. A demonstrated track record of project management with focus on facilitative and organizational skills.

For application information, click here

We are looking for a talented individual to join XenoPort, Inc as a Clinical Pharmacology expert, applying high medical, scientific and ethical standards to study designs to assist the Clinical Pharmacologist to efficiently define the clinical pharmacology of investigational drugs for assigned portion(s) of the clinical plan while adhering to all relevant regulatory requirements. The successful candidate will be a hands-on, multi-tasking scientist with excellent written and verbal communication skills, capable of interacting with all levels of the company colleagues, advisors, and partners, and consult as needed across discovery research efforts to provide appropriate clinical pharmacology input and focus to projects and programs at all stages.

• participating in the overall study planning, management, evaluation and documentation;
• providing scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of company lead candidates;
• working on operational aspects, including evaluation of Clinical Pharmacology Units and investigators with regards to study planning, placement and conduct;
• reviewing and provide input on CRFs and TLFs generated for clinical studies;
• evaluation of Clinical Pharmacology data (pharmacokinetics, pharmacodynamics) from clinical studies, interacting as required with Operational staff, Data Management, Biostatistics, Toxicology, Regulatory and other partners;
• providing clinical pharmacology expertise to determine and execute a cost-effective rapid drug development program, including the minimum number of studies necessary to make all the necessary internal decisions (e.g. go/no go, dosage in phase II) and ultimately to submit an NDA with the Clinical Pharmacology and Human Pharmacokinetics and Bioavailability sections of the NDA documents supporting approvable and marketable claims;
• timely preparation and quality of relevant documents (protocols, final study reports, IND and NDA summaries) or contributions to documents (INDs, NDA expert reports); and
• interacting with regulatory authorities with regards to Clinical Pharmacology issues.

Requirements:
PhD, MD or PharmD degree in an area relevant to pharmacokinetics and clinical pharmacology, and typically five or more years of relevant clinical and pharmaceutical industry experience. Experience in the planning and conduct of Clinical Pharmacology trials. Appropriate modeling and computer software experience. Good command of spoken and written English with excellent communication and presentation skills. Able to interact well within a team setting (e.g. with representatives from clinical groups, project management, preclinical research, regulatory affairs, drug safety). In-depth knowledge of PK and PD evaluation techniques using standard tools (WinNonlin, ADAPT II, etc.) and their practical application to drug development, experience writing relevant sections of regulatory filings. Familiarity with applicable FDA guidelines is required. Knowledge of population PK/PD modeling (NONMEM, S-PLUS.) is a benefit, as are previous experience with CYP450 inhibition/induction studies, IVIVC evaluation and drug interaction studies.

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We are looking for a talented individual to join the Drug Metabolism and Pharmacokinetics group, supporting discovery and development of novel small molecule prodrugs that use nutrient transporters to improve their absorption and distribution. This pivotal position will be responsible for the design, analysis and interpretation of drug metabolism (DM) aspects of preclinical and clinical studies.

• design, analysis, and interpretation of drug metabolism (DM) studies;
• analysis using molecular biology techniques, such as RT-PCR, Western blotting and hepatocyte culture;
• functioning as a project core team member representing DMPK with full scientific and technical responsibility/accountability for the tactical support of specific projects;
• integrating findings from in vitro stability, enzyme reaction and transport phenotyping, induction, inhibition, DDI potential, ADME (disposition, metabolite characterization, protein binding), modeling and simulation;
• possibility of supervising and/or mentoring others;
• effectively communicating in large or small group settings and assisting with building effective technical collaborations in a team environment;
• writing technically sound regulatory reports, applying an appropriate knowledge of relevant FDA and Pharma guidelines; and
• demonstrating sustained ability to exercise judgment and make sound decisions in regular communication with limited supervision from manager.

Requirements:
MS or PhD/equivalent in Biochemistry, Pharmacology or related discipline with five or more years of relevant experience. Extensive experience in drug metabolism studies and practical training in molecular biology, enzyme kinetics, and LC/MS analysis. Qualified candidates must be able to work independently and have excellent organizational, communication and problem solving abilities.

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We have an immediate opening for an energetic and talented individual to develop and validate bioanalytical methods in a GLP environment for the determination of novel drug molecules and metabolites in biological matrices using HPLC and LC/MS/MS.

• following appropriate SOPs, protocols, and other applicable regulations and providing timely analysis of biological samples from preclinical and clinical studies;
• exercising independent judgment and creativity and applying strict evaluation criteria for obtaining results;
• efficiently planning and scheduling work activities to ensure timely support for aggressive discovery and development programs; and
• writing technical reports, preparing presentations, and contributing to regulatory filings as needed.

Requirements:
The ideal candidate will have extensive experience in GLP bioanalysis, including hands-on method development and assay validation, and a record of compliance with GLP systems and procedures. Extensive experience in LC/MS/MS is required, as is familiarity with related techniques (sample precipitation, SPE, liquid extraction, etc). Sound knowledge of current GLP regulations is required. Excellent communication and organizational skills and the ability to interact with multidisciplinary teams are essential. May supervise the activities of other lower level personnel. Requires a BA/BS or MA/MS degree or equivalent with five to eight (or more) years relevant experience.

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We are looking for a talented individual to join the Pharmacokinetics group as a Pharmacokinetic expert, supporting preclinical and clinical development of novel small molecule prodrugs that use nutrient transporters to improve their absorption and distribution. This pivotal position will be responsible for the design, analysis and interpretation of pharmacokinetic (PK), toxicokinetic (TK), pharmacodynamic (PD), and drug metabolism (DM) aspects of preclinical and clinical studies.

• responsible for the design, data analysis and interpretation of pharmacokinetic (PK), toxicokinetic (TK), and pharmacodynamic (PD) aspects of preclinical and clinical studies;
• oversee the design and interpretation of appropriate PK studies and integrate findings from in vitro stability and in vivo PK;
• perform non-compartmental, compartmental and population pharmacokinetic-pharmacodynamic modeling of clinical and non-clinical data;
• participate and present the results in group and project meetings;
• participate on cross-functional teams to effectively identify and characterize high quality drug candidates;
• write scientific reports and prepare appropriate documentation to support applications for regulatory agency filing as required; and
• must have clear and effective communication skills and ability to build effective technical collaborations in a team model environment.

Requirements:
PhD/equivalent in biopharmaceutical sciences or pharmacokinetics or related discipline with two to five years of relevant industrial experience in pharmacokinetics, with an understanding of application of PK and PK-PD models and fundamentals of statistical modeling. Appropriate modeling and computer software experience and proficient in computer programs or PK software, i.e. WinNonlin, NONMEM or similar programs. Proactive in problem solving and able to independently manage timelines and priorities. Excellent interpersonal skills, and strong written and oral communication skills. Ability to work effectively in a multidisciplinary team environment.

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We are currently seeking an individual to become a member of our growing Preclinical Development team in providing a full spectrum of toxicology, safety pharmacology, and related preclinical safety studies.

• Design, contract, coordinate, monitor, and report toxicology and safety pharmacology studies for worldwide product registration.
• Participate in drug development project teams, communicating the relevance and interpretation of study findings to management.
• Prepare relevant sections of regulatory documents.
• Demonstrate a high level of proficiency, creativity, collaboration with others, and independent thought.
• Build effective working relationships throughout the organization to achieve goals.
• Maintain broad knowledge of state-of-the-art principles and theories and possess advanced knowledge of scientific principles and concepts in field of expertise.
• Proactively contribute to and demonstrate scientific leadership in scientific literature and in addressing scientific issues.

• Ph.D. in toxicology, pharmacology, or equivalent experience and at least 5 years experience in the pharmaceutical industry.
• Prior experience with CRO interactions is a plus.
• Ability to integrate toxicity data with pharmacokinetic profiles, and extrapolate non-clinical data to humans.
• Superior communications, interpersonal and organizational skills are essential, along with computer proficiency.

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We are looking for a talented scientist with broad experience in animal neuropharmacology models to join our discovery research group in this newly created position. This person will work closely with members of the discovery biology and medicinal chemistry groups to evaluate novel drug candidates for specific CNS targets.

• assessment of appropriate animal models for each project;
• establishment of needed models in house;
• supervision of specialized contracted (outsourced) studies;
• execution of relevant assays for on-going discovery programs;
• supervision of research associates in the execution of PD and PK studies; and
• contribution to the selection and development of CNS discovery programs.

Requirements:
Ideal candidate will have five to ten years of broad experience in the development of animal CNS efficacy models, including behavioral models, and their use in drug discovery programs. The ability to rapidly assess the particular assays appropriate for a given project, and to determine the most efficient route to accomplishing the studies, in house or outsourced, is a key responsibility of this position. Extensive experience in CNS drug discovery is an important component of candidates' background. The experience and ability to conduct pharmacokinetic studies for early stage feasibility projects is also important. A strong publication record is desirable. The successful candidate must possess excellent communication and collaborative skills, and demonstrated management abilities.

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We are currently looking for an energetic and talented analytical chemist to join our Analytical Research team. The group is well equipped with advanced analytical instrumentation and techniques, such as LC/MS, LC/MS/MS, GC/MS and NMR, as well as state-of-the-art data processing and management systems. This newly opened position will report directly to the Head of Analytical Research.

• Lead bioanalytical efforts for research projects by designing and performing method development and analysis for in-vitro and in-vivo samples.
• Provide daily supervision and scientific guidelines to analytical staff to ensure analytical support to biological research and development.
• Review or generate laboratory data, notebooks, protocols and reports. Oversee the operation and maintenance of all LC/MS/MS instruments.
• Serve as an analytical liaison in inter-departmental project teams or in interactions with external CRO.
• Participate in documentation preparation for regulatory filings or for business development. Remain current in bioanalytical technology, related regulation and literature.

Requirements:
The ideal candidate should have a Ph.D. degree with at least 10 years of relevant experience in analytical science and at least 4 years of management experience. Experience in drug discovery and/or development in pharmaceutical industry. Experience in in-vitro and in-vivo sample preparation methods. Hands-on experience with state of the art LC/MS/MS instruments and modern data acquisition and handling software. Familiarity with chemical structure and physical chemical property measurements for drug development. Track record of success in team work environment and in solving complex scientific problems. Good oral and written communication skills. Be able to work independently and have excellent organizational skills. Significant publications in major peer-reviewed scientific journals will be preferred.

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