(US-Massachusetts) Your responsibilities will be numerous in this hands on position. Two (2) positions exist! You will report to, and work closely with the Sr. Vice President of Medical Affairs to plan, direct and oversee clinical studies intended for FDA and foreign regulatory submission. Other duties include: providing clinical expertise and leadership to the company, design, coordinate and finalize clinical research protocols, consent forms, protocol amendments, and CRFs for assigned project(s), establish and maintain relationships with FDA medical staff, consult with Investigators on exceptions to eligibility or deviations from protocols, be responsible for ensuring the successful and timely recruitment of clinical research study participants, review, finalize, and update Investigator Brochures, finalize drug supply forecasts and study drug distribution plans. Requirements: 3-5 years experience overseeing Clinical Trial Activity is necessary. Your training should be in one of two (2) areas: Oncology (preferably Lymphoma) or CNS (preferably Alzheimers). NEW POSITIONS DUE TO COMPANY GROWTH!!
(US-Massachusetts) The successful candidate will design and conduct Phase I - III trials. This job function includes the planning of clinical development programs, strategic planning of submissions, preparation of s MISSION STATEMENT: Reporting to the COO, this key role is responsible for cientific and regulatory documents, and the implementation, conduct and summarization of clinical trials in the U.S. and abroad. RESPONSIBILITIES: Develop and maintain a Clinical Research group with global responsibility Develop and maintain a Regulatory Affairs group Oversee the clinical development process from concept through summarized data. Design and review protocols; analyze and summarize data; present as required to senior management and external audiences (including regulatory agencies) Identify, qualify, and contract with CROs, support organizations and consultants Provide medical expertise across the organization and participate on multidisciplinary teams Provide strategic guidance on experimental clinical trial design. When necessary, act as medical monitor EXPERIENCE: MD with internal medicine or similar board eligibility / certification. 3 years minimum industry experience with a proven success record in Clinical Research studies and trial design is required. Oncology experience preferred. Experience with early-stage (phase I, II) clinical studies Knowledge of relevant FDA and ICH regulations and guidelines. Knowledge of GCP's and clinical SOPs. OPPORTUNITY DUE TO COMPANY GROWTH!!
(US-Massachusetts) MISSION STATEMENT: Reporting to the President, the Director Medical Affairs will manage a growing department providing vision, leadership and mentoring for department staff. RESPONSIBILITIES: This highly visible Director is responsible for successful management and efficient and effective functioning of the department; oversight of departmental hiring and training; coordination and execution of projects involving clinical monitoring, medical writing, and safety and surveillance; client interactions; evaluation of new processes and methods; achievement of departmental corporate goals and objectives; develop working relationships with sponsors; manage personnel resourcing; implement and revise standard processes; provide drug development strategy; provide medical monitoring; participate in / attend FDA meetings; Occasional travel may be required. Requirements: M.D. and minimum 5 years experience including 2 years management experience; Be familiar with the basic principles of drug development; Strong technical skills in medical writing, protocol development, clinical research and project management; A demonstrated ability to manage projects and staff; strong interpersonal skills. Ability to: work well with all levels of management as well as in a team environment.
(US-Massachusetts) RESPONSIBILITIES: The Associate Director of Clinical Monitoring will direct a growing department providing vision, leadership and mentoring for department staff. This is a highly visible position and is responsible for: successful management and efficient and effective functioning of the department; successful coordination and execution of projects involving clinical monitoring; interdepartmental collaboration; interaction with clients; achievement of departmental goals and objectives; Develop and maintain departmental budget; Develop sponsor contracts and budgets; Implement and revise standard processes and procedures; Manage timelines, deliverables, and scheduling; Manage personnel resourcing; Participate in internal, client/sponsor, scientific and other presentations as required. Travel up to 25% may be required. Requirements: B.S. in life sciences. Must have minimum of 5 years experience in the pharmaceutical / biotechnology / CRO industry including a minimum of 3 years management experience. Must have very strong management skills with the ability to guide the company's Clinical Monitoring operations. Must have excellent knowledge of GCP, ICH guidelines and clinical monitoring processes and procedures.
(US-Massachusetts) The (Sr) Clinical Program Manager works within the Department of Clinical Operations to manage clinical studies that are designed to establish the safety and effectiveness of Company's products. This person initially will focus on early clinical development, but will have the ability to bring one or more of these products to Phase III development, as necessary. Skills required include study planning and training, study initiation, study management, and completion of final clinical study reports. Liaison with potential clinical investigators and management of Contract Research Organizations and other clinical resources is a significant aspect of this position. Responsibilities: Develop clinical development plans and study timelines. Participate in the development of clinical protocols, Investigator Brochures, consent forms, training material, and other clinical documents, as required by the project. Provide a liaison function between clinical investigators and scientific personnel in the development of programs and clinical studies. Arrange and manage resources to conduct clinical trials, including Contract Research Organization and Consultants. This will involve identifying and selecting resource providers and evaluating these services on an ongoing basis. Coordinate with other functional areas (e.g., Regulatory Affairs, etc.) Identify and evaluate clinical investigators; monitor the progress of investigators on an ongoing basis Keep to project timelines. Propose and implement solutions to problems that either jeopardize the schedule or the quality of the studies. Make sure that all tasks are completed that contribute to the conduct of a clinical study. Provide support for Clinical Operations, as required. This could include writing and reviewing department and company SOPs, maintain files, contribute to regulatory filings, etc. Requirements: BA degree required, advanced degree (e.g., MS, MPH) desirable. 3-5 years industry experience in clinical research. Previous management of investigator-initiated and early clinical development of vaccines desirable. Training and experience in Good Clinical Practices; excellent written and oral communication skills, familiar with word processing, database, and tracking software.
(US-Massachusetts) MISSION STATEMENT: To develop, support and manage regulatory strategies. To review and approve data packages for product candidates to ensure completeness, accuracy and validity of data in support of regulatory applications RESPONSIBILITIES: Anticipate consequences and assess impact of new or revised worldwide regulations and guidelines on the companys strategies. Review and approve key segments of regulatory submissions. Represent the company and effectively participate with senior level representatives of regulatory agencies worldwide. Effectively interact with senior company management to influence direction of the Regulatory Affairs group and associated company efforts. Communicate to senior management regulatory strategic & tactical plans to achieve company goals. Act as recognized leader in the drug development process with comprehensive and business knowledge in a variety of product areas. Work closely with R&D to develop an overall drug development strategy for all of the companys products. Allocate resources and coordinate the activities of personnel to achieve the companys objectives. Maintain an organization with high-level competencies and develop a succession plan for the group, to achieve the companys objectives. Act as a recognized expert to work teams and other functional organizations on complex problem resolution. EXPERIENCE: An advanced degree 10-15 years of industry experience Attention to detail and follow through Medical/Pharmaceutical specified education 5-10 years of experience in dealing with the FDA Extensive communication skills.
(US-Massachusetts) MISSION STATEMENT: Reporting to the Vice President, Clinical and Regulatory Affairs, you will develop and implement regulatory strategies for product development and approval; be responsible for regulatory documents, submission, and compliance issues; represent the company with domestic and international regulatory authorities; and provide regulatory support for various departments, projects, and teams/committees. RESPONSIBILITIES: Direct regulatory responsibility for company products. In conjunction with the VP, Clinical and Regulatory Affairs, develop and execute creative product development and regulatory strategies, including risk assessments, regarding submissions and compliance issues. Provide clear and valid regulatory guidance to company personnel throughout the research and development process. In conjunction with the VP, Clinical and Regulatory Affairs, direct and prepare clear and effective submissions and presentations for regulatory agencies, senior management and external parties. Keep abreast of all current Federal and International regulations appropriate for R&D operations Build and maintain excellent relationships with FDA and other regulatory agencies Review all clinical/pre-clinical/CMC documents for regulatory compliance and oversee all regulatory submissions. EXPERIENCE: This position requires a results-oriented person with an enthusiastic attitude, strong leadership and inter-personal skills and a solid understanding of the drug discovery and development processes. A minimum of 5 years of direct regulatory affairs experience within the pharmaceutical industry is required. A thorough understanding of Federal and International (including harmonization) regulations Significant experience in cGMP, manufacturing and CMC-related aspects of regulatory submissions Experience and knowledge in preparation of INDs, NDAs, MFs, BLAs, and supportive amendments of supplements. Strong interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
(US-Massachusetts) MISSION STATEMENT: Provide Regulatory guidance, strategic advice and contribute to a Regulatory project team planning on CMC issues. Handles all aspects of CMC-related activities for assigned biological development project. RESPONSIBILITIES: Review and assessment of all CMC documents for consistency Accuracy and conformance with all regulatory requirements; Identification of content, responsibility and timing of CMC documents for regulatory submissions; Coordinating and monitoring the progress of all CMC regulatory submissions; Providing regulatory guidance for CMC issues, processes and templates by working closely with Manufacturing and Quality through all phases of drug development; defining current regulatory requirements for technical submission (INDs, CTXs, BLAs, and DMFs); Directly interacting with regulatory authorities(internal) and Manufacturing and Quality (external) on CMC issues requiring agency feedback; and participating in pre-approval inspection activities. EXPERIENCE: A minimum of a BA or BS in chemistry (although other physical or biological sciences will be considered) with 2-5 years prior experience. Must be detailed oriented individuals capable of performing tactical CMC Regulatory Affairs Duties.
(US-Massachusetts) MISSION STATEMENT: The Medical Director, Clinical Safety will be responsible for insuring consistency of safety assessment, analysis and reporting across the company's clinical development programs. In addition, you will, in conjunction with Reg.Affairs, insure compliance with regulatory reporting requirements for clinical trials. He/she will work closely with the program specific Medical Directors in proactively assessing and addressing safety issues for each of the clinical development programs. This position will manage and develop a staff of Clinical Safety Managers. RESPONSIBILITIES: * Manage Clinical Safety Group, Insuring adequacy of training, job performance and career development. Will provide oversight to insure completeness and timeliness of reporting for both expedited as well as non-expedited serious adverse events. * Maintain electronic SAE database (including compliance with regulatory reporting requirements. * In conjunction with Clinical Data Management and Reg. Affairs, coordinate the effort of transitioning to MedDRA adverse event coding. * Working with Clinical Safety Group, analyze the performance of safety vendors, insuring integrity of safety information. * In conjunction with Regulatory Affairs and Clinical Operations, insure complete and timely updates of Annual Reports and Investigator for all clinical development programs. * Provide safety educational and safety training of all staff involved in clinical trials. * Remain up to date regarding ICH and FDA safety reporting requirements. * Will partner with the VP, Medical Operations to serve as key communicators to external parties, including FDA, with regard to safety issues for all clinical development programs. EXPERIENCE: MD required along with a minimum of 3 - 4 years experience in drug safety within the pharmaceutical industry. This experience would include direct knowledge of regulatory agencies reporting requirements regarding drug safety, and an understanding of general drug safety methodology. Direct experience interacting with health agencies and authorities, both US and Global, desirable. In addition, experience needed in line management, including human resources, budget, organization and planning functions.
