(US-Massachusetts) Responsibilities will include activities that support the planning, analysis, review, and interpretation of clinical data sets from research projects and protocols conducted by the clinical research group. Activities will include, but are not limited to, working with study team members on pre-study planning, protocol development (in particular, the statistical section of the protocol including sample size/power calculations), Statistical Analysis Plan preparation/review, oversight of the biostatistical activities of contractors and contract research organizations (CRO), data quality reviews, and review of tables/listings/figures and clinical study reports. Some SAS programming is required in response to requests from Clinical and other departments, and could include preparation of data distributions and data sets, and ad hoc listings and data analysis. Primary Responsibilities: 1.Work independently with project teams, consultants, and/or contractors, as appropriate, to plan clinical research projects and to develop statistical sections of protocols and Statistical Analysis Plans. Mentor/review work performed by more junior staff; provide statistical expertise to assist clinical project teams in project development and interpretation of data. 2.Biostatistical project management, and oversight of data and statistical tasks performed by contractors, including definition of schedules and staff requirements for data management and statistical components of projects from initiation to final report, including specification of deadlines. 3.Participate in meetings and teleconferences with regulatory agencies, and prepare written responses to agency questions, as needed. 4.Take initiative to improve processes to keep current with evolving industry standards for clinical research and participate in review/development of quality systems and processes. 5.Provide assistance to Quality Assurance to verify statistical programs, analytic results, and data sets used in analyses. 6.Provide assistance in the writing and review of statistical sections of technical documents and clinical study reports, upon request. 7.As appropriate, provide statistical consultations to clinical teams and contractors, and play a key role in preparing data and research materials for NDA and other regulatory submissions and ISS/ISE reporting. Requirements: Education: MS/PhD Experience: A minimum of 6 years industry and/or CRO experience with the design and analysis of clinical trials is required; 3 years of experience in a pharmaceutical or biotech sponsor organization is preferred. Demonstrated knowledge of applied clinical research statistics in support of pharmaceutical and/or biologics product development is required. The work history should demonstrate evidence of the ability to effectively manage numerous projects simultaneously and in an efficient manner. Experience with verbal and written communications with the FDA (CDER and/or CBER preferred) is required; experience with European regulatory filings and/or European clinical studies is preferred. Some experience with management of outside contractors/CROs is preferred. Excellent verbal and written communication skills and attention to detail are required as this position must function as an integral part of the study team.
(US-Nevada-Las Vegas) Managing Pharmacist - Las Vegas I am assisting to recruit a Managing Pharmacist for a client's Las Vegas location. Do you know anyone who would be interested in this? Here is more information. Key Responsibilities: Provide technical leadership and promote innovation in compounding products Forge key affiliations in the healthcare industry Use exceptional interpersonal skills to forge close working relationships with physician customer base, pharmacy employees and corporate management We are seeking someone w/ a Nevada Pharmacy license, strong business sense, experience and technical knowledge, PharmD or RPh w/ management experience. Compounding would be helpful, but not necessary. This is a priority position for our client. Salary is completely open and relocation within or to NV is an option.
(US-Maryland) Job Description: As the Director, Scientific Product Development, Oncology, you will provide scientific direction for the Company's Oncology Program. In this position, you will create the most scientifically valuable products and services for discovery, preclinical and clinical studies. You must be able to apply knowledge across medical oncology, genomics and cell biology to business development opportunities. You will also participate in the design and conduct of clinical trials. This position reports to the Medical Director. Responsibilities: Prioritizing diseases within the Oncology field for clinical, gene expression and biology studies Creating informative scientific experimental protocols Designing and medical monitoring of clinical trial protocols Identifying patient sources, clinical trial sites and establishing collaborations Overseeing clinical and experimental data analysis Developing genomic tools for application to patient stratification Requirements: MD with specialization in Medical Oncology or Cancer Biology with at least 5 years postdoctoral work experience, including 3 years in biotech or pharmaceutical industry Knowledge of the drug development process Experience with clinical data collection and analysis Experience with experimental model systems of disease Specialty board certification, molecular medicine, and/or genomics skills a plus Job Location: Mid-Atlantic Bonus/Benefits: Annual bonus, stock options, employee stock purchase plan, very good benefits Travel: Up to 50% Relocation Assistance: Yes.
