(US-California) In this position the successful candidate will direct, supervise, and manage large regional projects to the Sponsor’s satisfaction and ensure quality deliverables on time and within budget. S/he will manage the scope of work, objectives, quality of deliverables, and other project management activities of large, long-term, regional or global complex projects. In addition, s/he will also serve as primary contact for the Sponsor, assist in proposal development and presentation, provide input on scope and budget development, and finalize project budget and scope of work. Further duties include developing project plans for all phases of the project lifecycle and providing technical expertise. Line management responsibilities include reviewing workload for all direct reports, mentoring, training and supervising staff. QUALIFICATIONS The ideal candidate will have a BA/BS degree in a relevant field complemented by a minimum of five years of clinical or research industry experience. This experience will be marked with a minimum of four years of Project Management, with skill sets in communications planning, organization, business knowledge, and supervision. Three years of line management experience with direct reports is required and PMI PMP Certification is strongly preferred. Ability to travel up to 30 percent and strong communication and organizational skills are also required. COMPENSATION Compensation is competitive and includes base salary range of $85K-$100K dependent on experience and a comprehensive benefit package.
(US-California) The Drug Safety Associate will manage adverse event reports from both clinical and post-marketing setting. Working in conjunction with the Director of Drug Safety, Medical Directors, other members of Clinical and Medical Affairs, and Regulatory Affairs, s/he will ensure acquisition of appropriate information, assessment of the adverse events, and timely reporting of SAEs including expedited and annual reporting. S/he will also perform the triage for adverse events to determine regulatory reporting requirements and contact investigators, coordinators or other consumers to solicit comprehensive information about reported adverse events as well as relevant follow-up information. S/he enters cases into the safety database, writes case summaries, and performs analysis of similar events. Additional duties include reviewing literature of clinical and preclinical reports to provide the context for all reported serious adverse events, preparing IND safety reports for medical review by the Director of Drug Safety and for filing by Regulatory Affairs with the FDA and other appropriate agencies, and participating in reconciliation between clinical trial and safety databases. The Drug Safety Associate will communicate with corporate partners regarding safety issues, coordinate and oversees the notification of investigators and IRBs of IND safety reports, assist the Drug Safety Director in responses to inquiries for safety information and preparation of periodic safety reports, and assure SOPs are appropriate and the personnel are trained accordingly. S/he will also participate in safety related education programs for internal and site personnel, and participate in writing the safety sections of clinical protocols and CRFs. QUALIFICATIONS The ideal candidate will have a PharmD, RN, MSN or equivalent complemented by a minimum of three years of experience in the pharmaceutical industry. A knowledge of GCP adverse event reporting guidelines, excellent written and verbal communication skills, and organization skills are also required. S/he must be self-motivated, able to function independently and as a team member and have attention to detail. COMPENSATION Compensation is competitive and includes a base salary between $70K-$80K as well as a comprehensive benefit package. Relocation is available.
(US-Pennsylvania) The Senior Director/VP of Global CQA will establish company policies through SOPs etc. regarding interpretation/implementation of Good Clinical Practice, advise Clinical Research staff regarding GCP compliance and training, establish policies for Global CQA operations; oversee Global CQA functions of consulting, auditing, validation, and SOP administration. S/he will facilitate other departments’ enhancement of their quality of services provided to sponsors, oversee budgets of US and International CQA, oversee development of CQA sections of project proposals and coordinate, host, and facilitate follow-up of audits of the company by sponsors and FDA as well as providing guidance for inspections by other regulatory agencies. S/he will also oversee development and implementation of US and International Master Quality Plans for non-contracted CQA audits and other internal services and represent Global CQA at meetings of the Corporate Executive Committee, other management teams, and other departments, and at external meetings. QUALIFICATIONS The ideal candidate will have a Bachelors degree (Masters preferred) in Life Sciences/Biomedical or equivalent complemented by eight years experience with clinical research/auditing, seven years pharmaceutical/biotech/CRO experience, and five years management experience COMPENSATION Compensation is competitive and includes base salary and a comprehensive benefit package.
(US-California) The Clinical Data Specialist will oversee and coordinate clinical data management activities in support of clinical research studies, including editing and coding of data, QC and QA audits, and interaction with CROs and contractors. S/he will perform or direct database design, development and validation, lead selected teams in CRF design, and ensure that the clinical data management activities adhere to timelines and SOPs. Additionally, s/he will lead the team selected to design case report forms, maintain a thesaurus management system, prepare the clinical data plan for each trial, assist in development, training and maintenance of department SOPs. S/he will create custom queries, procedures and reports, resolve data discrepancies in clinical studies, and evaluate new procedures or technologies to increase productivity without sacrificing quality. QUALIFICATIONS The ideal candidate will have a Bachelors degree complimented by three to five years of relevant experience in the pharmaceutical industry. S/he will have an understanding of clinical practices, regulatory requirements, and overall data management process. Knowledge of SAS, data processing experience with clinical databases, and the ability to use SQL, PLSQL, Oracle Reports for customizing queries, procedures and outputs is also required. COMPENSATION Compensation is competitive and includes a base salary between $50K-$65K as well as a comprehensive benefit package. Relocation is available.
(US-Utah-Salt Lake City) The Pharmacokineticist will be responsible for the pharmacokinetic characterization of drugs within assigned clinical projects and will report to the Senior Director of Safety Assessment and DMPK specific responsibilities. S/he will design and prepare clinical PK development strategies and study protocols, participate in generating documents for regulatory submission (annual updates, IND and CTD), perform and supervise PK and PK/PD analyses, as well as preparing or editing final reports. Additionally, s/he will manage multiple projects simultaneously as well as working with members of the Clinical Research team to implement PK strategies and word as part of a multidisciplinary team to support the development of drug candidates. QUALIFICATIONS The ideal candidate will have a Ph.D. in Pharmacokinetics or related Pharmaceutical Sciences field complemented by two-five years pharmaceutical industry experience. S/he will have a demonstrated ability to communicate effectively through oral and written presentations as well as the ability to work well in a team environment. NONMEM analysis and/or PK/PD modeling experience are required. COMPENSATION Compensation is competitive and includes a base salary of $88K-$105K and a comprehensive benefit package. Relocation is available for this position.
(US-California) The Sr. SAS Clinical Programmer will provide SAS programming leadership and collaborate cross functionally within the study team. S/he will plan, execute and validate SAS programming in support of clinical study reports for all phases of clinical studies, work with Clinical Team to formulate analysis data definitions, summary table, and listing specifications. Additionally, s/he will be responsible for the timely completion of SAS programming deliverables without compromising efficient use of I/O and CPU, developing and designing clinical programs, making recommendations for improvements, and implementing documentation and validation practices related to SAS programming per SOPs. Further responsibilities include participating in application development planning, design and support and providing technical guidance and mentoring to less experienced SAS programmers. QUALIFICATIONS The ideal candidate will have a Bachelors (advanced degree strongly preferred) in a relevant field complemented by a minimum of five years of SAS programming experience in a pharmaceutical/CRO clinical trials (Phases I-III) environment. S/he must be fluent in clinical data presentations style, statistical procedures and regulatory guidelines as well as be able to perform advanced techniques using SAS version 8.2 including BASE, GRAPH, STAT, the Macro facility and the ODS. Further requirements include strong analytic, critical thinking, oral and written communication skills. S/he must be detail oriented, highly motivated, able to take initiative, work well under pressure and shifting priorities, and work independently and as a team member. A working knowledge of SAS/IntrNet, CONNECT, SHARE, SQL, Oracle, and RDBMS is desirable. A good understanding of computers at system level and how SAS system configurations interact with the operating system and proficiency in UNIX and scripting is also preferred. COMPENSATION Compensation is competitive and includes a base salary between $85K-$100K as well as a comprehensive benefit package. Relocation is available for this position.
(US-California) The Manager of Clinical Programming will be responsible for managing a team of Clinical Programmers supporting clinical data management. S/he will work collaboratively with direct report, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. In addition, s/he will ensure completeness, correctness and consistency of clinical data and data structure. Further responsibilities include providing leadership in the area of systems, processes and tools for clinical data collection and management, hiring, supervising, training, and coaching direct reports, and participating on departmental management team, providing strategic direction for clinical programming. QUALIFICATIONS The ideal candidate will have a Masters degree (Ph.D. preferred) in a Biomedical Science, clinical background complemented by eight 8 years working experience in SAS programming in a CRO or bio/pharmaceutical setting, including experience managing people. Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is also required. S/he will ensure clinical programming work is completed in a consistent manner and validated according to department practices, in addition, knowledge of relational database design, FDA regulations. Familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems is also preferred. S/he will have excellent communication, problem solving and people/project leadership skills as well as excellent verbal and written communication skills and interpersonal skills. Further requirements include a knowledge of pharmaceutical clinical development and ability to provide programming supports needs for NDA and other regulatory submissions. The ideal candidate will be a team player with an entrepreneurial spirit, a strong and assertive communicator in the company of other such people, and someone with sound judgment and flexibility with a dynamic personality. COMPENSATION Compensation is competitive and includes a base salary and a comprehensive benefit package. Relocation is available.
(California, Texas, and New Mexico) The Regional CRA will monitor clinical data at study centers located primarily within the region. S/he will assist with in-house study management, interact with coordinators and physicians, review clinical data captured on case report forms, and generate data queries and complete required reports. This position requires approximately 60-80% travel within the region. QUALIFICATIONS The ideal candidate will have a Bachelors Degree in a medical/clinical/biological field, a minimum of two years CRA field monitoring experience and knowledge of FDA regulations/guidelines and GCP. S/he must have excellent communication skills, be self-motivated and directed with the ability to manage time independently, and be computer literate. Experience in monitoring neurology trials and background as healthcare professional such as R.N. or R.P.h. are a plus, but not required. COMPENSATION Compensation is competitive and includes a base salary of $50K-$70+K as well as a comprehensive benefits package.
(US-California) The ideal candidate for this position will be responsible for performing analyses on clinical trial data, including listings, tabulations, graphical summaries and formal statistical estimates and tests. S/he must be able to assess quality of analysis data, perform cross study analyses and be able to create and use/write SAS macros to automate all of the above functions. Additionally, the person in this role will design and create analysis databases for electronic NDA submission. S/he must have a thorough knowledge of study design and NDA submission requirements. S/he will also be responsible for mentoring junior programmers in the areas of SAS coding and study analysis. QUALIFICATIONS To qualify for this role, the ideal candidate will have a Bachelor's (Masters preferred) degree in Statistics or Computer Sciences complemented by 5 years of biotech/pharmaceutical industry experience as well as good written and oral communication skills. S/he will have exceptional knowledge of SAS/Base, SAS/Macro, SAS/Graph, SAS/Stat. The ability to write maintainable, supportable and well-documented SAS code is essential. Other helpful qualifications include experience with the UNIX operating system, the fundamentals of C-shell programming, filing of electronic NDA submissions, S-plus and working with contract research organizations. COMPENSATION Compensation is competitive and includes a base salary or $70K-$100K (DOE) and a comprehensive benefit package. Relocation is available for this position.
(US-California) The ideal candidate for this role will provide advanced technical expertise as part of the Stat Programming team to develop and maintain programs to meet internal and external clients’ needs. S/he will plan and lead the development of project-related solutions to the full scope of statistical programming tasks by providing Statistical Expertise. In this role, this individual will serve as a Stat Programming Lead representing Statistical Programming on the corporate team. S/he will plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphics, and listing summaries. S/he may also be responsible for program analysis, database manipulations, and transfers of data for internal and external clients. Moreover, this person will integrate databases from multiple studies or sources, develop listing and table specifications, and independently bring project solutions to peers and management. Additionally s/he will develop and maintain good communications and working relationships both with internal teams and external clients. This may require some interaction with multiple team members to negotiate timelines, responsibilities, and deliverables. In this role, s/he may mentor other team members in departmental procedures and developing technical expertise and may serve as a Project Manager or liaison with other departments. S/he will program, test, document statistical programs and tools in accordance with SP standards and validation procedures. QUALIFICATIONS To qualify for this position, the ideal candidate will have a Bachelors degree in Computer Science/Statistics or a related field complemented by 4+ years of relevant work experience. S/he will have experience with Clinical Trials. COMPENSATION A competitive base salary of $50K-$85K, dependent on experience and a comprehensive benefit plan is available for this position. Relocation assistance will be provided.
(US-Washington-Seattle) The ideal candidate for this position will be responsible for providing statistical consultation on issues related to the design and analysis of clinical trials. S/he will contribute to protocol development and will author the statistical sections of protocols and the statistical analysis plans as well as be responsible for analysis of study data and will collaborate with team members to author study reports. This individual will also manage CRO production of statistical output. QUALIFICATIONS To qualify for this position, the ideal candidate will have a Ph.D. (Master's Degree accepted with greater experience) in statistics/biostatistics complemented by a minimum 4 years experience in a pharmaceutical or related field. S/he will be familiar with regulatory guidelines in a pharmaceutical research setting and clinical trials experience is required. COMPENSATION A competitive base salary between $80K-$90K, a comprehensive benefits plan, and stock options are available for this position. Relocation assistance will be provided.
(US-California) In this key role, the ideal candidate will serve as the head/deputy head of the local Biostatistics department ensuring that target productivity (FTE, utilization, and output) levels are met. S/he will manage an assigned group of high-level staff/management from the Biostatistics, Statistical Programming, and RDQC sections and has direct personnel reports typically consisting of Supervisor - Associate Director level staff from each function. This individual will participate in sales meetings as required and will also oversee departmental proposal preparation. S/he will monitor the budgets and scope of office projects and will take action necessary to maximize realization. Ensures that departmental staff contributes to intra- and interdepartmental process improvement to achieve "best practices". Ensures that appropriate levels of professional development and training are provided to staff. Serves as a biostatistical resource for the department, ensuring scientific integrity in the application of statistical methodology to Phase II-III clinical trials. Provides statistical direction, technical oversight, or consultancy on major projects or on projects involving particularly complex statistical analyses. Represent clients at FDA or other scientific meetings as required. QUALIFICATIONS Requires Ph.D. in biostatistics or statistics with 7 years of relevant experience, or Masters degree in biostatistics or statistics with 10 years of relevant experience. A minimum of 4-5 years managing staff in a contract research or pharmaceutical industry setting. Familiarity with most complex statistical methods that apply to Phase II-III clinical trials. Working knowledge of SAS. Excellent written and oral communication skills. COMPENSATION Compensation is competitive and includes a base salary of $80K-$140K as well as a comprehensive benefits package. Relocation is available for this position.
(US-New York-Buffalo) The successful candidate will engage in activities ranging from consultations on study design through development and evaluation of models, performance of simulations, and presentation of results. QUALIFICATIONS The ideal candidate will have a PhD or PharmD/MS in a related field and knowledge of pharmaceutical drug development including compartmental pharmacokinetic analysis or strong data analysis/modeling skills. Experience with NONMEM is preferred. Excellent writing and oral presentation skills, a desire for responsibility, consistency, and dependability are also required. COMPENSATION Compensation is competitive and includes a base salary range of $80K-$90K depending on experience. Relocation is available for this position.
(US-Missouri-Kansas City/Independence) The Clinical Project Manager is responsible for meeting or surpassing client expectations by providing high quality clinical trial management services through effective management and integration of the project team. S/he will serve as the key contact to the sponsor and actively work to manage their expectations and meet their goals by planning, organizing, and managing multi-size clinical trial studies working to effectively meet goals and ensure timely completion of the study. Specifically, this individual will facilitate the site selection and recruitment process, conduct investigator meetings and selection, and develop and deliver study specific material (e.g., tracking logs, templates, monitoring tools, study binders, process manuals). S/he will set-up project files and determine maintenance requirements and a quality control plan; communicate to the team and ensure appropriate training takes place, and work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design. S/he will also manage project resources, timeline, budget, and staffing and set appropriate project expectations (e.g., milestones, time lines, project scope) with sponsors, team members and their direct reports. S/he will manage staff and step in where needed. QUALIFICATIONS Candidates will have a BA or BS degree in a science-related field with medical, clinical or pharmaceutical research focus complemented by a minimum four years of clinical experience in the Pharmaceutical/CRO industry as well as demonstrated experience, at least two years minimum, in project management tasks (e.g., work plans, financial budgets, timelines, status reports, issue management, resource and personnel management). A focus in Oncology is preferred but not mandatory, but experience working on a team across multiple functional areas and strong knowledge of clinical trial operations, ICH/GCP and federal regulations is preferred. The ideal candidate will have a demonstrated ability to successfully supervise and lead others as well as both excellent communication, relationship building and interpersonal skills and organizational skills and ability to prioritize and multi-task S/he will have or will be working toward PMP Certification. COMPENSATION Compensation is competitive and includes base salary range of $60K-$85K and a comprehensive benefit package. Relocation is not available for this position.
(US-California) The Senior SAS Programmer will work with Biostatisticians to provide SAS programming support in analyzing clinical trial results, generating report tables, listings and graphs for final reports. S/he will also design, develop, validate and maintain general use software applications and provide specialized programming support to the clinical project team and the data management group. QUALIFICATIONS The ideal candidate will have a B.S. or M.S. in Statistics, Computer Science, Life Sciences or other analytical science, complemented by at least two years experience in the analysis of clinical trial data, and strong SAS programming skills, including SAS macros. Experience with VMS, S-Plus, SAS/Internet, web design or Oracle is preferred. COMPENSATION Compensation is competitive and includes a base salary range of $60K-$78K and a comprehensive benefit package. Relocation is available for this position.
(US-California-Los Angeles) The ideal candidate will fulfill the role of Biostatistician on multi-protocol projects. S/he will develop protocols, review CRFs, and prepares analysis plans. In this role, the Statistician will also communicate with clients regarding statistical analysis issues as they arise. S/he will be responsible for interpreting analyses and writing statistical sections of study reports. S/he may also serve as Project Manager on various small Statistical Operations projects. QUALIFICATIONS The ideal candidate for this position will have either a Ph.D. in Statistics or Biostatistics complemented by one year of industry-affiliated working biostatistical experience in the clinical trials environment or a M.S. degree in Statistics or Biostatistics complimented by two years working biostatistical experience in the clinical trials environment. S/he will have knowledge of complex statistical methods that apply to Phase I-IV clinical trials complimented by strong working knowledge of SAS, familiarity with other packages (S+, SUDAAN, StatXact) COMPENSATION Compensation is competitive with a base compensation range between $70K-$90K and includes a comprehensive benefits package. Relocation is available for this position.
(US-Massachusetts-Boston) The Regional Clinical Research Associate II will manage the implementation and conduct of study protocols at research sites. S/he is responsible for performing monitoring visits including site qualification, initiation, monitoring and close-out visits and maintaining regular contact with study sites to ensure protocol/GCP compliance. S/he will participate in Investigator meetings and other study training meetings as required and prepare for and participate in Sponsor and FDA audits. S/he may also act as a mentor to junior staff. QUALIFICATIONS The ideal candidate will have a Bachelors in a scientific discipline complemented by a minimum of two years field monitoring experience within a CRO or other clinical research setting. S/he will have a strong understanding of Medical Terminology, Physiology, and Pathophysiology, a working knowledge of GCP, strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. The ability to travel 75-85%, professional demeanor and appearance, diplomacy skills, and strong written and verbal communication skills are required. COMPENSATION Compensation is competitive and includes a base salary of $40K-$60K as well as a comprehensive benefits package.
(US-California-San Francisco) The Senior Biostatistician will participate in one or more project teams as biostatistician. S/he may serve as lead biostatistician on NDA/BLA, or on one or more multi-protocol projects, or serve as project manager on small statistical operations projects. Additional duties will including developing statistical methods sections of protocols, reviewing CRFs, preparing analysis plans, and writing specifications for analysis files, consistency checks, tables, and figures. S/he will communicates with clients regarding study protocol or statistical analysis issues as they arise as well as communicating with study team members regarding study execution. In addition s/he will interpret analyses and write statistical sections of study reports. QUALIFICATIONS The ideal candidate will have a Masters degree (Ph.D. preferred) in Statistics or Biostatistics complemented by a minimum of two to three years statistical experience in the clinical trials environment. Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials Strong organizational skills Familiarity with PC and VAX computing systems Strong working knowledge of SAS, familiarity with other packages (e.g., S+, SUDAAN, StatXact) Ability to solve moderately complex problems (identify, propose & implement solutions) Ability to work in team situations Shows strong individual initiative Strong commitment to teamwork and quality Ability to effectively manage multiple tasks. COMPENSATION Compensation is competitive and includes base salary of $70K-$90K and a comprehensive benefit package. Relocation is available for this position. **Position will be filled as Senior Biostatistician or Biostatistician II depending on qualifications and experience.
(US-Massachusetts-Boston) The Clinical Data Manager II will review data, assist in database design and testing, design CRFs and guidelines, design and test logic checks, generate queries for missing or discrepant data, and utilize tools to code medical terms and medications. S/he will interface with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues and provide clinical data management expertise to all aspects of the study. Additionally, s/he serves as a resource to other Clinical Data Management staff and/or personnel and clients outside of the department. QUALIFICATIONS The ideal candidate will have a Bachelor's degree in a relevant field complemented by a minimum of three years experience in clinical data management including some experience in a CRO, pharmaceutical or biotech environment. S/he must have a thorough understanding of the clinical research development process, standard operating procedures, GCP, clinical data management process, physiology, pharmacology, clinical study objectives and methodologies, the definition of serious adverse events and how they apply to review of clinical data. Furthermore, s/he must have excellent verbal and written communications skills, problem-solving skills, a good understanding of database design, and CRF design techniques. The ideal candidate must be organized and detail-oriented and have the ability to lead a large-scale project and/or an initiative by effectively providing training, organization and support. COMPENSATION Compensation is competitive and includes a base salary of $50K-$65K as well as a comprehensive benefits package. Relocation is available for this position.
(US-Massachusetts-Boston) This candidate must be able to identify and develop accounts and markets with significant sales potential for our rapidly growing reagent offering. The ability to work in teams to identify and grow revenues in these areas is required. Will also provide expert technical support for customers and internal Sales & Marketing personnel. Will monitor and report on sales and product performance; travel to trade and vendor shows, and travel to customer sites. Requires a MS or PH.D in molecular biology or a related field, or equivalent laboratory research experience, including PCR, quantitative PCR, and/or other applications using thermal cyclers. Excellent organizational and interpersonal communication skills and the ability to work under stressful situations in a calm, responsible and flexible manner. Sales experience a plus.
