(US-California-San Francisco) Under the general guidance of the Director of Statistical Programming, the candidate will have lead programming responsibility for an entire project with oversight for the conduct and day-to-day statistical programming operations. The position is responsible for the development, validation, execution, maintenance, documentation, and archival of analysis datasets and programming code used in the analysis of clinical trial data targeted for regulatory submission. Collaborate with clinical data management and biostatistics peers to meet clinical development team goals. Ensure programming work is completed in a consistent manner and validated according to department practices. A key responsibility and function will be to investigate new methodologies and techniques for the computer processing and statistical analysis of clinical data. A BS degree (MS preferred) in statistics or equivalent with a minimum of 5 years of industry experience. Thorough understanding of the clinical trials design and reporting process and regulatory reporting requirements, preparation of NDAs and/or PLAs. Possess advanced problem solving skills along with exceptional knowledge of SAS. Experience interacting with others for defining and implementing user-defined reports is also essential. Experience working with contract research organizations is a plus. Excellent written and verbal skills are required.
(US) Client is a Midwest biopharmaceutical company. Our client has an opening for a Senior Clinical Scientist. This full-time position is for a dedicated person to be responsible for the implementation and execution of clinical trials under the supervision of the Director of Clinical. Responsibilities include: Working with the Director and Senior Director to design, prepare and implement clinical protocols and amendments; direct the protocol specific activities of outside contractors, and report protocol results. Candidates will participate on development teams and will interact with internal and external experts during individual, investigator and expert meetings. The candidate will also plan investigator meetings, identify, evaluate, and recruit clinical investigators, and supervise ongoing CRO relationships and performance. Candidate will resolve patient/subject eligibility and protocol deviation issues, monitor subject safety and participate in addressing issues from regulatory agencies. Candidate will prepare clinical outsourcing specifications for RFPs and will develop, negotiate and manage study budgets. Additional responsibilities include participating in interim and final report preparation for regulatory submission, contributing to the preparation of the clinical elements of a BLA/NDA, and participation in major scientific meetings. Requirements: The position requires proven scientific and clinical expertise relevant to pharmaceutical clinical trial programs. Candidate must have depth of knowledge to represent department on development teams and to critically evaluate strategies for clinical trials and outside expert advice. Proficiency in clinical studies involving complex design issues and experience in preparation of clinical sections of IND, BLA, or NDA is desired. The ideal candidate will have a RN, MS, or MPH degree, 6+ years of experience & expertise in pharmaceutical clinical trial programs. Experience or education relevant to the development of therapeutic agents for cardiovascular or lipid modulating indications is preferred.
(US-New Jersey) A biopharmaceutical company, specializing in Oncology drug development, is looking actively for an Associate Director of Quality Assurance. This candidate will be handling all third party management. such as vendors, the laboratory, clinical areas and the manufacturing areas. In this role, you will Provide oversight and direction for quality systems in all aspects of pharmaceutical product lifecycles within the company and at contract sites. You will represent the company at vendor sites to provide guidance in Quality Control and Manufacturing Controls issues. You will Interact directly with representatives of FDA and other regulatory inspection bodies. You will work with project teams to provide QA guidance in developing new drug products and evaluation of licensing opportunities. Lead investigations of quality issues and establish corrective/preventative action plans. Develop vendor metrics and proactive programs to ensure continued compliance with company requirements and GMP regulations. Qualifications: Bachelors degree in Chemistry, Pharmacy, Engineering or related field. Advanced degree preferred. Demonstrated knowledge and expertise in all aspects of manufacturing QA and industry practices. CQE, or CQM is desirable. 10+ years experience in pharmaceutical Quality Assurance including vendor QA programs, with at least 5 years in Quality management positions. Demonstrated success in supporting development and commercialization of pharmaceutical products. Knowledgeable in FDA and European regulatory submission requirements. Ability to prioritize, schedule and manage multiple projects and resources simultaneously. Excellent oral and written communication skills. Our client offers competitive compensation, comprehensive benefits including 3 weeks vacation, 401k, and stock option participation.
(US-New Jersey) An international Contract Research Organization is looking for a Senior Project Manager who has experience as a liaison for many parts of the clinical trial. This person will work with the Operations, Data Management, Finance, and Regulatory teams and be the point of contact with all of them. Our client needs someone who has interacted on a wide scope, serving as the point of contact in all of these areas. 1. Serve as the key contact to the sponsor and actively work to manage their expectations and meet their goals 2. Plan, organize, and manage multi-size clinical trial studies working to effectively meet goals and ensure timely completion of the study 3. Facilitate the site selection and recruitment process 4. Conduct investigator meetings and selection 5. Develop and deliver study specific material (e.g., tracking logs, templates, monitoring tools, study binders, process manuals) 6. Set-up project files and determine maintenance requirements and a qualify control plan; commmunicate to the team and ensure appropriate training takes place 7. Work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design 8. Work with Business Development and Business Management to communicate resource needs, issues, and milestones met 9. Complete study close out procedures at project completion 10. Manage the project resources, timeline, budget, and staffing 11. Conduct team kick-off and training 12. Set project expectations (e.g., milestones, time lines, project scope) with sponsors, team members and their direct reports 13. Complete status reports and communicate outcome to all involved parties 14. Manage the project budget and specifications to ensure project goals are met on time and on budget while statisfying sponsor expectations 15. Track project milestones and report progress and issues Manage issues effectively by resolving or escalating issues to the appropriate individuals 16. Provide project support, performance management, and career development guidance to direct and indirect reports 17. Create and enable a positive team morale Discuss role responsibilities, define performance expectations, provide on-going feedback and conduct regular performance reviews (verbal and written) as indicated by company policy 18. Provide on-going written and verbal feedback to all indirect reports and their direct supervisors Assist direct reports in obtaining training that is role specific (e.g. 19. monitoring, guidelines,SOPs, reports) or administrative (e.g., project tracking or attendance training) 19. Serve as an advocate for both the direct and indirect reports during the project staffing process (e.g. staff on projects that are aligned to the employees skill development needs and career goals) Provide administrative guidance Manage personal career development and administrative tasks. Qualifications - BA or BS degree in a science-related field with medical, clinical or pharmaceutical research focus -Minimum four years of clinical experience in the Pharmaceutical/CRO industry -Demonstrated experience, at least 1 year, in project management tasks (e.g., workplans, financial budgets, timelines, status reports, issue management, resource and personnel management) -CNS, HIV or Cardiovascular background preferred but not mandatory -Experience working on a team across multiple functional areas Strong knowledge of clinical trial operations, ICH/GCP and federal regulations -Demonstrated ability to successfully supervise and lead others -Excellent communication, relationship building and interpersonal skills -Excellent organizational skills and ability to prioritize and multi-task Proficient in Microsoft Office (e.g., Word, Excel, and Outlook).
(US-New Jersey) A pharmaceutical manufacturing company, located in Southern New Jersey, is looking for a Director of Quality Assurance. The successful candidate will have 8 to 10 years of experience in quality assurance and quality control, with significant managerial experience in plant manufacturing environments. Additional expertise in all areas of FDA compliance is critical. The successful candidate will demonstrate the leadership, management skills and experience capable of maintaining close working relationships with the R&D, operations and marketing groups. You will function as a coach and mentor, in collaboration with the operations organization to make quality a priority focus for all personnel. The successful candidate must be comfortable with matrix reporting relationships, not only with the QA/QC management reporting directly to this position, but also with senior compliance and regulatory management in our clients' corporate location on the west coast. This position requires the ability to influence operations, regulatory and research functions. Additional responsibilities will include serving as the QA/QC liason with our client's international marketing partners, managing the customer complaint programs, validation and calibration services, internal and external auditing programs and facilities maintenance. The position requires a BA/BS, with at least eight to ten years of progressively advancing QA/QC management experience in the pharmaceutical industry. A Masters degree is preferred, as is experience in drug development. Strong laboratory experience is required, along with liquid chromatography expertise. A comprehensive knowledge of current FDA and international regulations and guidelines along with extensive experience in communicating with FDA representatives is required. A thorough knowledge of compendial, ISO and ICH requirements is necessary. Excellent leadership, along with excellent verbal and written communication skills, are essential. The ideal candidate will demonstrate abilities to positively influence team decisions with excellent team interaction skills. Business travel is required for this position. Our client offers a very competitive compensation and benefits package including health, dental, vision, life, disability insurance, 401K plan with company match, three weeks vacation, employee stock purchase plan, employee stock options, and tuition reimbursement.
