Biotechnology Jobs

Senior Director Clinical Affairs
Provides leadership to the Clinical Affairs group and assumes global responsibility for the clinical development of investigational and marketed drugs. Manages and mentors Clinical Research Directors and Director, Clinical Operations to ensure deliverables and timelines are met.
Provides global vision for the Clinical Affairs group to keep group on track with business priorities.
Uses clinical expertise to meaningfully participate in Maxim’s management committee meetings.
Interfaces with groups and individuals inside and outside of the company to oversee clinical trials research.
Works with the head of Drug Development to set the Clinical strategy in line with business objectives.
Staffs Clinical Affairs department appropriate to the short and long term needs of the organization.
Other duties as may be assigned by Executive management.

Requirements
Four year college curriculum or BS/BA degree plus 15 year(s) clinical/research experience (e.g., employment in a patient care setting, such as nursing or pharmacy; clinical laboratory experience; experience as a clinical research monitor/coordinator OR,
Master’s degree, Pharm.D. or 12 years of post-graduate training in a health-related discipline plus 8 year(s) clinical research experience (as described above) OR, Ph.D. plus 9 year(s) clinical/research experience (as described above).
Has successful history of drug filing.
Experience with clinical research methodology/activities (e.g., study design, site monitoring).
Other factors to include verbal and written communication skills, ability to work independently, initiative, planning and organizational skills, behavioral flexibility, decisiveness, problem solving abilities and leadership skills.
Contact: Trish Ryan

Medical Director
Clinical Research . Responsibilities: Candidate will work with a multidisciplinary team involving R & D project teams, clinical project managers, business management, regulatory, and others to execute trials. Trials may also utilize external contract research organization (CRO) resources. Will manage 1-2 clinical programs (Phase I & II), interface with Research to assess new product opportunities, develop clinical research strategy and product development plans. Candidate will also study protocol development, liaison with clinical investigators, conduct medical assessment and disposition of adverse events. Work with Business Development to secure new collaborators and present trial results. Will work on Phase I studies across the board. New program, Phase I studies will start with this position. Will interact with scientists. Will have 3-4 direct reports.

Required Qualifications:
M.D. degree plus accredited residency and accredited fellowship in relevant clinical specialty. (CNS diseases, neurology, oncology, endocrinology)
Clinical Pharmacologist (scientist and researcher components)
Minimum of five years experience in clinical drug development in a pharmaceutical (preferably) or biotechnology company.
Experience with 3-5 Phase I programs from early stages. Seeking experience in order of preference: 1) Endocrinology 2) CNS 3) Oncology / broad scale training
Contact: Trish Ryan

Manager Regulatory Affairs--Device
Individual will plan, develop and implement regulatory strategies and direct regulatory activities. Will provide regulatory guidance to product development teams and coordinate with various project teams to provide regulatory guidance for international strategies. Will manage clinical trials and data analysis process for submissions and review labeling, advertising and other promotional materials for regulatory compliance. BS/MS/PhD with biotech/pharm experience including 5+ years in regulatory affairs with 1+ years in a managerial or leadership capacity. Strong knowledge of regulations/ guidelines governing development of in-vitro diagnostic products and proven success preparing domestic regulatory submissions for development stage products required. Must have experience interacting with the FDA and other regulatory agencies, as well as thorough knowledge of GMP, GLP and GCP and of foreign regulations pertaining to the manufacturing and distribution, including export, of IVDs.
Contact: Trish Ryan

Clinical Science-MD (Gastroenterologist)
Several excellent opportunities exist at prominent biotechnology companies for CRA's levels I-III and Senior CRA. Will independently management multiple clinical trials (all phases). Responsible for managing the activities of the CROs to their assigned projects to assure compliance with GCP and ICH guidelines. Additional duties include; assisting senior staff with budget negotiations and clinical trial agreements, preparing confidentiality agreements, assisting with quality and validity of clinical trial data, interaction with other departments within the company, may represent the department at clinical project meetings, will provide clinical project managers with ongoing study status reports and assisting in preparation and submission of documents for regulatory filing.

Requirements:
BS in a biological or physical science or a nursing degree. 3+ years in a CRA role. Experience working in a pharmaceutical company managing CRO’s is highly desirable. Must have excellent organization skills, be a team player, function independently and be able to interact effectively with company personnel as well as CROs and investigational sites. Minimal travel required.
Contact: Trish Ryan

Director Clinical Operations
Provide operational leadership for the clinical operations group to ensure global consistency. Identifies needs and implements solutions regarding major clinical processes and activities to include Clinical SOP and GCP training and compliance, budgets, document control and contract and clinical resources management. Invents/provides efficient processes to Clinical Development teams.

Primary Duties and Responsibilities
· Manages and mentors a centralized group of Clinical Research Associates to ensure GCP adherence and consistency on processes across programs.
· Manages resource allocation to clinical projects.
· Identifies global processes and tools to assist the Clinical Research group.
· Oversees document control and central files for the Clinical Development group.
· Contract management.

Requirements
· Four year college curriculum or equivalent or BS/BA degree plus a minimum 8 year(s) direct pharmaceutical clinical/research experience or equivalent.
· Previous supervisory experience with staff, external vendors and corporate partners.
Contact: Trish Ryan

Biostatistician/Data Mngt--Cl Rsrch
Responsibilities:Reporting to the Director, Biostatistics, this position will provide biostatistical and data management support for the design, analysis, and reporting of clinical trials in one or more clinical program areas. Will also collaborate with Clinical Research scientists, consultants, and other biostatisticians in the development of clinical trial protocols. Participate in the development and review of clinical trial data capture processes and media. Ensure that all protocol-required data are collected in consistent formats that reflect any applicable standards. Review and approve data management plans and database quality control/audit plans prepared by CROs. Prepare and approve statistical analysis plans, and collaborate with CRO biostatisticians in the preparation of statistical analysis plans as necessary. Oversee and monitor CRO performance of biostatistics and data management tasks to ensure that timelines are met and that any resource issues are identified and resolved. Provide biostatistical support to nonclinical areas of the company, including consulting and data analysis. Qualifications:M.S. in Biostatistics or related field (with 5+ years of experience), or Ph.D. (with 3+ years of experience). Experience in the design, analysis, and reporting of Phase I to Phase III pharmaceutical clinical trials. Thorough understanding of data management processes is essential. Experience in the pharmaceutical industry, CROs, or FDA. Held titles of Senior/Principal Project Biostatistician on one or more projects, working with CROs, and interacting with FDA. Strong SAS skills required.
Contact: Trish Ryan

Senior Director QA/QC
7-10 yrs. experience in the field with GCP, QA/QC group, want director or above, very hands on good technical background. Would like experience in Oncology, AntiInflammatory. Approved product experience. Need someone to come on board and organize the QA/QC department, the organizational structure, staff etc. and make recommendations. Validation and EDMS (Electronic Data Management System) are important. Manufacturing is contracted outside company.
Contact: Trish Ryan