Full Time Positions
Executive Director Clinical Development – Vaccines: Central NJ Apply
Executive Director Clinical Development – Vaccines: Development stage biotech in central NJ is looking for an MD/PhD Immunologist who is a well-known, accomplished Clinical Scientist in the immunological treatment of cancer and who has a strong understanding of current clinical immunology. Very desirable to have a body of published research in the areas of Therapeutic Clinical Immunotherapy or Oncology and a track record of successfully developed, approved drugs. Background in and comfortable with speaking at national meetings, representing the company and its technology to the scientific and investment community. Ability to fit in with a dedicated and productive group in a small company environment.

Director, Clinical Development Central NJ Apply
Director, Clinical Development – Major player in clinical research, located in central New Jersey, seeks an MD (preferred) or PhD in a health related field coupled with at least 7 yrs. experience in drug development with an emphasis on Phase II/III/IV and established authorship and review of documents for regulatory submission. Responsible for the scientific, strategic and clinical oversight of programs to evaluate, register and market pharmaceutical agents. Lead study team and provide strategic clinical guidance to Medical Affairs and Marketing activities, including development, design and implementation of clinical studies and publications. Key participant in product in-licensing and acquisition review. Will supervise all aspects of clinical program management, data analysis and approve all clinical documents, study and program activities. Supervise protocol design of clinical protocols, direct review of protocol and contribute to protocol as needed. Responsible for preparation/approval of IND and NDA/sNDA submission activities. Contribute to Clinical Development Plans and oversight of clinical program budgets. Present at investigator/partner/internal team meetings. May contribute, review and approve product labeling and related promotional materials. May have 2+ direct reports and manage Managers.

Sr. Vice President, Regulatory Affairs Central NJ Apply
Senior Vice President, Regulatory Affairs – Specialty pharmaceutical company, located in central NJ, seeks an experienced (10+ years) professional to serve in the role of managing all regulatory aspects of their products. Responsible for initiating/providing Strategic Direction, Design, Development Submissions, Launch, Advertising/promotion and Labeling. Will manage interaction with various Regulatory Authorities. Will provide business development review, from regulatory standpoint, for new products that are purchased. Provide directional guidance to the business on how to prepare products for approval and keep abreast of evolving global regulatory requirements. Knowledge of domestic and international laws, regulations and guidance as well as of clinical development, including responsibilities for successful management of development milestones and global market authorization. Several NDAs, a BLA in the works. Need not have managed a large staff. Big Pharma background a big plus. MS degree preferred; energy and competence required!

Clinical Study Manager/Sr. CRA Manhattan Apply
Clinical Study Manager/Sr. CRA – Small biotech, located in midtown, seeks a Professional with at least a BS degree, who wishes to grow their skills in a fast-paced, multi-tasking environment. 4 years experience managing large multicenter clinical trials. There are two large Phase IIb studies and this person will manage one; 30 – 40 sites, with 300-400 patients and up to 10 vendors. Must have monitoring and vendor management experience. GI background very desirable. Must be proficient in site management for development of study specifications and finalization of contracts/budgets including central labs, Data Mgt/EDC, medical writing, biostatistics, patient recruitment, diaries etc. Will assist in writing and manage development of protocols, informed consent forms, study manuals, portions of INDs, safety updates/reports, IB updates, CRF, Annual Report updates. Manage the Study Budgets and oversee/participate in CSRs, source documents, and patient diary development. Assist in negotiating trial site budgets, site payments and assist with CRO management and payment. Assist in safety review and reporting. Flexibility required and a bent for taking risks.

Salary: 80 – 120K

Sr. Principal Biostatistician Northern NJ Apply
Sr. Principal Biostatistician – Leader in the clinical research industry, located in Northern, NJ, is looking for an experienced Sr. TA Statistician who will be responsible for all statistical tasks of individual clinical trials. May serve as a project level Program Statistician. Perform clinical trial design/planning, write analysis plan, monitor reporting activities including exploratory analyses to support publications. May be assigned to lead small project with increasing autonomy/accountability. Track clinical trial/allocated project activities/milestones and ensure timeliness and quality of all deliverables. Adhere to SOPs, Master Analysis Plan, GCP & regulatory guidelines. MS in Statistics with 6 yrs. exp or PhD with 2 yrs. background

Principal SAS Programmer Northern NJ Apply
Principal SAS Programmer – Leader in big pharma seeks an BS (MS preferred) in Statistics/CS/Math w. at least 5 years experience in a programming role supporting clinical trials as well as expert knowledge of SAS and good understanding of global clinical trials practices, procedures and methodologies. Good understanding of regulatory requirements (GCP, ICH) and background in providing recommendations for maintenance or development o of global policies/procedures/clinical data presentation standards. Responsible for all programming aspects (analysis datasets, pooled datasets, listings/tables) for Phase I – IV clinical trials and project level activities for small drug indications. Lead programming activities including early phase project, indication, publication activities, maintaining efficient interfaces with internal/external customers. Develop resource plans and develop/comply with project/study standards and specifications following internal guidelines. Participate in the selection of CROs.

Sr. Drug Regulatory Affairs w. Strategy No. NJ Apply
Sr. Drug Regulatory Affairs w. Strategy – Major presence in pharmaceutical industry, located in No. NJ., seeks a PharmD or PhD to fill a FT position. Must have 3 years experience in Regulatory and a basic working knowledge of discovery, development, manufacturing and marketing. To provide US regulatory strategic direction as US Regulatory Lead of global teams and US product teams for projects of moderate complexity and or discrete components (line extensions, new indications) of larger projects of moderate complexity. Will assist in strategizing/planning/executing submissions of varying complexity and serve as interface with the FDA and business teams, and demonstrate leadership on the team as well. Manage decision-making and conflict resolution surrounding regulatory issues and ensure appropriate escalation to management when necessary. Develop regulatory risk management/contingency plans and analyze regulatory environment for impact on project plans. Development experience a definite plus. Must have Oncology or Virology or Inflammation Therapeutic Areas. Local applicants preferred.

eCRF Development Senior Specialist Northern NJ Apply
eCRF Development Sr. Specialist – Top-rated pharma, located in northern NJ, seeks a BA/BS in Life Sciences, Math, or CS and 3+ years exp. in clinical programming, set up of clinical databases and CRF design gained in a pharma or CRO environment. Strong knowledge in database support – ORACLE OC/RDC, PL/SQL or equivalent database mgt. system and solid knowledge of reporting support – SAS, SQL or equilvalent ad-hoc query/reporting tools. SAS desirable. Understanding of clinical database management systems and/or relational databases in clinical trials. Ability to analyze the impact of complex changes to clinical standards, to multi-task and switch between different tools for database design and management. Will develop/maintain trial specific database applications, including eCRFs, validation programming, monitoring reports and database specifications in support of in-house and outsourced trials globally for Phase I – IV. Solid understanding of ICH and Health Authority guidelines/regulations as they pertain to clinical database management, clinical data reporting and computer systems. Excellent communication skills required to be able to work with a wide variety of global customers face to face and on the phone/email.

Associate Director, Biostatistics Northern NJ Apply
Associate Director, Biostatistics – Northern NJ Leader in Clinical Research seeks a PhD in Statistics w. 5 yrs. of pharmaceutical experience and strong statistical and data analysis skills, as well as solid knowledge of drug development process. Experience in supporting NDA submissions and strong ability in protocol development, analyses and clinical trial reports/publications of Phase I-III clinical trials. Knowledge of FDA/ICH guidelines, SAS, S-Plus and R computer packages. Good project management skills. To support/participate in the development of a clinical program. Review protocols and CRFs for soundness of trial design. Write statistical methodology section of the protocol and prepare analysis plan and programming specifications. Perform inferential analyses. Write/review statistical sections of the clinical trial report, help to prepare global Health Authority submission and oversee CRO deliverables for trials contracted out.

Expert Statistician Northern NJ Apply
Expert Statistician – Leading player in the pharmaceutical space seeks a PhD w. 5+ yrs of experience /knowledge of clinical trials in at least one TA. Solid background in drug development process. Serve as Statistical Leader and Project Manager for all deliverables globally for a clinical development program or a mega trial. Ensure that clinical development program meets scientific, regulatory, quality and commercialization requirements. Ensure ECD-Bios and modeling/simulation contribution is fully integrated into the project. Plan/track project level activities and establish/maintain project standards (master analysis plan, full development project specifications). Interact with Health Authorities as appropriate.

Senior TA Statistician Northern NJ Apply
Sr. TA Statistician – Leader in clinical research, located in No. NJ, seeks a PhD w. 5+ years experience, w. a background in all tasks of a Trial Statistician as well as knowledge of drug development and HA guidelines. Responsible for all statistical tasks of individual clinical trial design/planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase. Track clinical trial project activities and milestones and ensure timeliness and adequate quality of all deliverables for assigned trials and project tasks.

Consulting Positions

Instructional Designer with Wavepad Software Central NJ Apply
Instructional Designer with Wavepad Software – Innovative, leader in clinical research, located in central NJ, seeks a BS/BA with 3-5 yrs. in Instructional Design (related exp) working with training systems. Solid understanding/application of adult learning principles and training methods and thorough knowledge/expertise with e-learning tools/software. Ability to storyboard/create a lesson plan and experience leading projects. Captivate, Articulate required, as is background in recordings/voiceovers using Wavepad SW. Will provide instructional design/development expertise to the Training Organization, providing instructional materials and training delivery methods through the use of best practices methodology (ADDIE – a must). Develop and conduct training assessments to determine the learner’s comprehension/competency of the subject matter. Plan and participate in training program pilots to assure the effectiveness and quality of the training program design/delivery and deploy finalized training. Lead the collaboration on content, design and delivery with SMEs, Technical trainers, Managers, etc to produce instructional materials in compliance with learning needs. Develop instructor guides/participant manuals and develop/perform evaluation of the program design. Excellent interpersonal, facilitation, presentation and communication skills. Must hit the ground running.

Biostatistician with Oncology Hudson Valley, NY Apply
Biostatistician with Oncology – MS in Statistics (PhD preferred) with at least 4 yrs clinical research experience needed for fast growing pharma located in the Hudson Valley, NY. To provide statistical support to projects for one or more clinical trial. Review statistical outputs to ensure data and analysis is consistent within a clinical study; interpret/communicate the statistical results to internal clinical groups and work closely with Data Managers and Statistical Programmers to ensure data integrity is maintained. Under direct supervision of Manager of Biostatistics, author the statistical section of the clinical protocol and statistical analysis plan. Must be able to work effectively with Managers of Biostatistics, Clinical Data Management, Database Administration and Statistical Programming

Senior Clinical Data Manager Hudson Valley, NY Apply
Senior Clinical Data Manager – Growing pharma, specializing in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley, seeks a BS in Biological Sciences and 6+ years exp. in clinical data management. To serve as Lead CDA for projects for all activities up to and including database lock. Responsible for eCRF design review, database design for new protocols which includes validation (UAT)m ensuring timely/quality data are delivered to appropriate personnel, writing/implementing Clinical Data Management Plans which include Edit Check Plans and ensuring validation of database and programmed edit checks. Additionally, responsible for patient review in compliance with SOPs & guidelines, performing data review in conjunction with medical/safety review, writing queries and updating the database if req’d, writing eCRF completion instructions, coding of the data and ensuring database lock timelines are met. Adhere to SOPs and Guidelines and participate in the development of SOPs and Guidelines. Must be proficient with EDC systems (InForm preferred) and background with CRF Design (Adobe InDesign preferred) Travel up to 20%

Drug Safety Physician Hudson Valley, NY Apply
Drug Safety Physician – Pharmaceutical leader, specializing in the discovery/development of innovative molecular targeted therapies in NY, seeks an MD with experience in drug safety/pharmacovigilance and familiarity with regulatory guidelines and requirements. Knowledge of drug development procedures. Will provide medical assessment for a high volume of cases, (possible causality, seriousness, labeledness/expectedness and regulatory reportability) for pre and post approval activities. Will also perform review of adverse event coding (ARISg a plus) for individual safety cases and aggregate information from clinical trials. Ongoing evaluation of potential new safety signals for their products. Assess developing safety information, anticipate potential impact, communicate implications and develop strategies for clinical and regulatory issues. Oncology background nice.

Associate Director, Clinical Research Hudson Valley, NY Apply
Associate Director, Clinical Research – Growing pharma, specializing in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley, seeks an MS or PhD with ten years of solid clinical research management experience, a thorough understanding of the drug development process and 10 years of Oncology background (a must). Five years managing multiple large global Oncology trials as well as at least 2 yrs. exp. as Global Program Leader for a clinical development program (a compound from Phase I through to NDA submission preferable). Background managing large, multi-project teams comprised of CPMs, Sr. CRAs, CRAs, CRCs. Experience managing global CROs as the sponsor company. Will run and actively participate in Oncology Clinical Trials, particularly in Phase III, managing up to 10 Clinical Program Managers, as well as those that report to them. Will be held accountable for everything related to the compound, including planning and implementation of the studies, project deliverables, budgets and timelines. Will have functional management responsibilities for all personnel in Clinical Operations. Strong knowledge of GCP and ICH guidelines, regulatory requirements and QA procedures. Must have ability to effectively problem solve and use clear judgment relating to national/international regulations, guidelines, Investigator and CRO interactions. Manage/provide oversight of in-house deliverables and monitoring visits for assigned studies and for evaluation/selection of sites, study initiation, routine study monitoring and close out activities.

Clinical Research Associate II Hudson Valley, NY Apply
Clinical Research Associate II – Growing pharma, specializing in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley, seeks a degreed CRA with 2-4 years monitoring experience and must have some Oncology background. Assist the Director in the areas of study planning and implementation including protocol and CRF preparation, Informed Consent preparation/review, study site evaluation and selection, study initiation, routine study monitoring, study closure and assist in the preparation of safety and final study reports and IND annual reports. Strong working knowledge of GCP and ICH guidelines, regulatory requirements and QA procedures. Will assist with the planning, coordination and description of clinical drug and non-clinical study supplies. Participate in site selection, study implementation and ongoing study management of study sites via CROs.



Global Clinical Program/Trial Manager Hudson Valley, NY Apply
Global Clinical Program/Trial Manager – Growing pharma, specializing in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley seeks a degreed professional with 6+ yrs. relevant Clinical Operations experience with at least 2 yrs managing large global Oncology trials (Phase II registration trials a must). Will serve as a Leader for a large global trial from beginning/study start-up to the end, which includes a regulatory submission to the FDA, EMEA for US & EU approvals. Principal role includes management and oversight of CROs, and multiple vendors who track their biomarkers, ECGs, Labs from start to finish. CROs will be responsible for drafting protocols, CRFs, monitoring plans, CRF instructions, Clinical Study Reports and NDA documents. Manage staff of 4-5 CRAs that will perform site visits (pre-study, initiation, routine and closeout), visits for data collection, source data clarification, clinical drug supply accountability and review of regulatory documents/filed. Design, communicate and implement project plans and work in collaboration with clinical contracts for development, approval and financial management of overall study budgets/vendor contracts. Track/report project activities and manage study timelines.

Senior Clinical Research Associate Hudson Vallely, NY Apply
Senior Clinical Research Associate – Growing pharma, specializing in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley, seeks a degreed CRA with 3-5 yrs of monitoring experience with Oncology as a must! Will support the Clinical Project Manager in managing all US Operations (up to 50 sites). Tasks include preparing protocol and CRF, Informed Consent (and review), monitoring plans, as well as study site evaluation/selection, study initiation, routine study monitoring and study closure. Will prepare final study reports, monitoring plans, abstracts, responses to QA data audits, presentations and manuscripts and Investigator Brochures. Strong knowledge of GCP and ICH guidelines, regulatory requirements and QA procedures. Will assist w. establishing/monitoring study progress and updating study timelines. Assist with CRO Vendor/Contract CRA selection.

Administrative Assistant Hudson Valley, NY Apply
Administrative Assistant – Growing pharma, specializing in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley, seeks a multi-tasking, energetic, efficient and experienced Assistant to provide all administrative support to the Executive Director of Clinical Operations. Manage the calendar, make travel arrangements, arrange all aspects of internal meetings, videoconferences, teleconferences, complete expense reports, timecards etc. Manage all arrangements for frequent meetings with external visitors including transportation, refreshments, presentation set-up etc. Host and coordinate schedules for Senior external visitors. Maintain filing system, compile quarterly and monthly business reports. Degree nice.

Clinical Research Associate I Hudson Valley, NY Apply
Clinical Research Associate I – Growing pharma, that specializes in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley, NY, seeks a BS plus at least I year relevant monitoring experience in the field of oncology (a must). Up to 50% travel. Assist in study planning/implementation including protocol and CRF preparation, Informed Consent Form preparation and review study site evaluation/selection, study initiation, routine study monitoring, study closure and may assist in the preparation of clinical study reports, Investigator and IND annual reports. Knowledge of GCP/ICH guidelines, regulatory requirements and QA procedures. Will assist with the planning/monitoring/destruction of clinical drug and non-clinical study supplies. Perform pre-study site visits, site initiation visits, routine monitoring visits for data collection, source data clarification/resolution of data discrepancies, study drug accountability, review of regulatory documents/files and site closeout visits.

Clinical Research Coordinator Hudson Valley, NY Apply
Clinical Research Coordinator: Growing pharma, that specializes in the discovery/development of innovative molecular targeted therapies, located in the Hudson Valley, NY, seeks a BS with one year relevant clinical experience. Must have Oncology experience. Knowledge of GCP and/or ICH guidelines, regulatory requirements and QA procedures. Receive and disseminate study-related regulatory documents and correspondence from clinical sites including 1572s, CVs, Investigational Review Board approvals/renewals, IRB membership lists, Informed Consent Forms, advertisements, protocols and amendments, lab certifications and clinical lab reference ranges, and study closure documents. Screen documents for completeness/compliance with protocol and appropriate regulations, and investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of the data. Up to 20% travel to clinical study sites to assist w. monitoring and maintenance of regulatory files and assist the Study Monitor with other appropriate duties. Develop/maintain/track supplies of non-drug study materials to ship to sites and process all IP shipments. Track and process clinical study and site payments. Team Player.

Clinical Research Scientist - Phase IV Northern NJ Apply
Clinical Research Scientist – Phase IV: Northern NJ leader in the clinical research industry is looking for an upbeat MS (preferred) in Life Sciences with at least 2 years experience in clinical research preferably in MS, Transplant or Schizophrenia therapeutic areas. Must be extremely organized, who can multitask on different studies cross-therapeutically and ensure that all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Manage clinical study material and implementation of issue resolution plans, as well as Investigator Initiated Research Protocols, including budgets of 30-40 studies. Maintain ongoing communications with Physicians for timeline purposes. Incorporate studies into a spreadsheet that provides up-to-date status of each of the studies. Meet with Team on monthly basis and report on the status of the trials. Flexible, proactive professional who is ready to organize the team!