San Diego Opportunities

Scientific Positions

Development Positions

Medical Director/Sr. Medical Director (CNS)
Manager, Clinical Trials Material
Clinical Project Assistant

Administrative Positions

Legal Counsel/Contracts Attorney
Contracts and Finance Manager
Administrative Assistant

Medical Director/Sr. Medical Director (CNS)

(Ref#MDCNS0606DVK)

While working as a member of the Development Team, the Medical Director/Sr. Medical Director, CNS, will design and finalize protocols and other trial documents for Phase I-II-III clinical trials; identify and recruit clinical trial sites and investigators and manage these relationships; oversee clinical monitoring and safety; coordinate data management and analysis; and relate to and manage external consultant and advisors. An M.D. with 3-5+ years clinical development experience in a pharmaceutical company is required. Additional requirements include: direct experience in preparing protocols; CNS Board certification; experience working with CROs; and direct involvement and interactions with the FDA. Filed NDA is a plus, but not required, as is experience with FDA and ICH regulations relating to GCP and conduct of international clinical trials.

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Manager, Clinical Trials Material

(Ref#MCTM0208RA)

This position is responsible for the management of Clinical Trials Material (CTM) in support of Global R&D Clinical Trials and other supportive research or development needs. Responsible for determining CTM requirements through protocol review, ensuring label compliance with applicable regulations, establishing optimal packaging & distribution strategies, tracking and reconciling drug supplies and monitoring product re-test dates. Maintains databases appropriate for CTM management operations and provides timely documentation and reports.

The position will interface with other internal departments and contract research organizations to coordinate execution of these activities. Additional responsibilities may include maintaining departmental reports and files, updating SOPs, and other special projects.

M.S./B.S. or equivalent in pharmacy or a related discipline coupled with at least 5 years of experience in managing clinical trials material. Good understanding of the CTM forecasting, distribution and reconciliation process. Excellent communication, organizational, problem solving and interpersonal skills with the ability to work in a global development and manufacturing environment. Demonstrated ability to multitask in high pressure, changing conditions and to work as part of a larger team.

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Clinical Project Assistant

(Ref#CPA0907BL)

We are currently seeking a Clinical Project Assistant to become an integral part of our Clinical Project Management Team. This position will provide comprehensive support to the clinical team in the administration of clinical trials.

The essential duties and responsibilities of this position will include:

Procuring and reviewing site regulatory documents
Maintaining study-specific tracking systems
Processing all forms concerning data collection, payments, and other materials regarding clinical trials
Managing active study files and preparing key documents for archiving. Attending project team meetings, preparing meeting agendas and minutes and provide updates on project performance.
Assisting in preparation for an attending client meeting including the generations of team meetings agendas and minutes. Providing communication with investigational sites and vendors regarding non-medical and logistical issues (at the discretion of the Project Manager)

This position requires a strong working knowledge of GCP's, ICH Guidelines and FDA Regulations, a demonstrated ability to multi-task and work effectively in a fast-paced environment, ability to work independently, excellent written and verbal communication and diplomacy skills, proficiency with MS office applications including MS Excel, Word and PowerPoint. Experience working in the pharmaceutical, biotechnology or CRO industry in an area of clinical research highly preferred. 2-3 years experience and BA/BS preferred.

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Legal Counsel/Contracts Attorney

(Ref#LC1007GB)

The successful candidate will have primary responsibilities management of contracts for ACADIA's discovery and development departments, including drafting and negotiating of CDAs, NTAs, consultant agreements, and other commercial contracts. Must demonstrate experience in general corporate matters, including corporate organization, securities compliance, drafting transactional documents, license agreements, employment law, risk management, and contract management. This position requires 2-5 years experience in-house or at a major law firm. In-house experience not required. Must have JD from an accredited law school. Must be able to work as a team and independently with the exercise of good business judgment.

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Contracts and Finance Manager

(Ref#CFM0108BL)

The Contracts and Finance Manager will be responsible for the coordination of contracts and capital expenditures to ensure that contract requirements are met within project timelines. The contracts aspect of the position may deal with contracts requiring non-routine attention. Coordinate with vendors, contract requestors, legal, and finance departments in processing contracts from request stage to fully executed contract stage. Will be involved in evaluation of contract proposals and negotiations. Maintain and organize contract related documentation and tracking system through the entire process and prepares status reports.

Ensure contract priorities are set and are coordinated with inter-department/intra-department project requirements. Assists Project Managers in evaluating change orders. The finance aspect will coordinate and ensures that invoice processes are completed accurately and on time. Reviews invoices for accuracy.

Works closely with project teams to deliver accurate information for financial reporting. Has frequent contact with external customers in regards to payment issues. Assists Project Managers in budget management including forecasting.

This position requires excellent communication skills, demonstrated Inter-departmental teamwork, effective project management and organizational skills, detailed oriented and proven ability to work under pressure with multiple priorities. A minimum 3-5 years experience in a similar role in biotech, pharmaceutical industry or CRO and a BA/BS in business administration, finance, or other related field is required. Must have MS OFFICE skills including proficiency with MS office applications including MS Excel, Word, Outlook, PowerPoint and database management.

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Administrative Assistant

(Ref#AA0108BL)

The Administrative Assistant will provide administrative support to the Sr. Director of Clinical Operations and the Clinical department.

Provides analytical and specialized administrative support to relieve and assist executive, administrative, line and staff managers of complex details and advanced administrative duties. May handle special projects and execute research and data analysis tasks. Analyzes problems, determines approach, compiles and analyzes data and prepares reports and recommendations. Coordinates activities between departments and outside parties. Contacts company employee's at all organizational levels to gather information and prepare reports. Work is generally of a critical or confidential nature. Assignments may be in various functional areas.

The ideal candidate will have at least a high school diploma and a minimum of 5 years in an administrative assistant role supporting multiple people. The position requires strong proficiency in Word, Excel and PowerPoint (Livelink is a plus.), good presentation, communication skills, and the ability to adapt to an ever changing environment. The ideal candidate must be able to work with executives and their assistants. Biotech/ Pharmaceutical experience preferred.

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San Diego Job Postings Benefits Recruiters Scandinavia		Home » Careers » San Diego » Job Postings San Diego Opportunities Scientific Positions Development Positions Medical Director/Sr. Medical Director (CNS) Manager, Clinical Trials Material Clinical Project Assistant Administrative Positions Legal Counsel/Contracts Attorney Contracts and Finance Manager Administrative Assistant Medical Director/Sr. Medical Director (CNS) (Ref#MDCNS0606DVK) While working as a member of the Development Team, the Medical Director/Sr. Medical Director, CNS, will design and finalize protocols and other trial documents for Phase I-II-III clinical trials; identify and recruit clinical trial sites and investigators and manage these relationships; oversee clinical monitoring and safety; coordinate data management and analysis; and relate to and manage external consultant and advisors. An M.D. with 3-5+ years clinical development experience in a pharmaceutical company is required. Additional requirements include: direct experience in preparing protocols; CNS Board certification; experience working with CROs; and direct involvement and interactions with the FDA. Filed NDA is a plus, but not required, as is experience with FDA and ICH regulations relating to GCP and conduct of international clinical trials. Apply Now! \| Send job to a friend Manager, Clinical Trials Material (Ref#MCTM0208RA) This position is responsible for the management of Clinical Trials Material (CTM) in support of Global R&D Clinical Trials and other supportive research or development needs. Responsible for determining CTM requirements through protocol review, ensuring label compliance with applicable regulations, establishing optimal packaging & distribution strategies, tracking and reconciling drug supplies and monitoring product re-test dates. Maintains databases appropriate for CTM management operations and provides timely documentation and reports. The position will interface with other internal departments and contract research organizations to coordinate execution of these activities. Additional responsibilities may include maintaining departmental reports and files, updating SOPs, and other special projects. M.S./B.S. or equivalent in pharmacy or a related discipline coupled with at least 5 years of experience in managing clinical trials material. Good understanding of the CTM forecasting, distribution and reconciliation process. Excellent communication, organizational, problem solving and interpersonal skills with the ability to work in a global development and manufacturing environment. Demonstrated ability to multitask in high pressure, changing conditions and to work as part of a larger team. Apply Now! \| Send job to a friend Clinical Project Assistant (Ref#CPA0907BL) We are currently seeking a Clinical Project Assistant to become an integral part of our Clinical Project Management Team. This position will provide comprehensive support to the clinical team in the administration of clinical trials. The essential duties and responsibilities of this position will include: Procuring and reviewing site regulatory documents Maintaining study-specific tracking systems Processing all forms concerning data collection, payments, and other materials regarding clinical trials Managing active study files and preparing key documents for archiving. Attending project team meetings, preparing meeting agendas and minutes and provide updates on project performance. Assisting in preparation for an attending client meeting including the generations of team meetings agendas and minutes. Providing communication with investigational sites and vendors regarding non-medical and logistical issues (at the discretion of the Project Manager) This position requires a strong working knowledge of GCP's, ICH Guidelines and FDA Regulations, a demonstrated ability to multi-task and work effectively in a fast-paced environment, ability to work independently, excellent written and verbal communication and diplomacy skills, proficiency with MS office applications including MS Excel, Word and PowerPoint. Experience working in the pharmaceutical, biotechnology or CRO industry in an area of clinical research highly preferred. 2-3 years experience and BA/BS preferred. Apply Now! \| Send job to a friend Legal Counsel/Contracts Attorney (Ref#LC1007GB) The successful candidate will have primary responsibilities management of contracts for ACADIA's discovery and development departments, including drafting and negotiating of CDAs, NTAs, consultant agreements, and other commercial contracts. Must demonstrate experience in general corporate matters, including corporate organization, securities compliance, drafting transactional documents, license agreements, employment law, risk management, and contract management. This position requires 2-5 years experience in-house or at a major law firm. In-house experience not required. Must have JD from an accredited law school. Must be able to work as a team and independently with the exercise of good business judgment. Apply Now! \| Send job to a friend Contracts and Finance Manager (Ref#CFM0108BL) The Contracts and Finance Manager will be responsible for the coordination of contracts and capital expenditures to ensure that contract requirements are met within project timelines. The contracts aspect of the position may deal with contracts requiring non-routine attention. Coordinate with vendors, contract requestors, legal, and finance departments in processing contracts from request stage to fully executed contract stage. Will be involved in evaluation of contract proposals and negotiations. Maintain and organize contract related documentation and tracking system through the entire process and prepares status reports. Ensure contract priorities are set and are coordinated with inter-department/intra-department project requirements. Assists Project Managers in evaluating change orders. The finance aspect will coordinate and ensures that invoice processes are completed accurately and on time. Reviews invoices for accuracy. Works closely with project teams to deliver accurate information for financial reporting. Has frequent contact with external customers in regards to payment issues. Assists Project Managers in budget management including forecasting. This position requires excellent communication skills, demonstrated Inter-departmental teamwork, effective project management and organizational skills, detailed oriented and proven ability to work under pressure with multiple priorities. A minimum 3-5 years experience in a similar role in biotech, pharmaceutical industry or CRO and a BA/BS in business administration, finance, or other related field is required. Must have MS OFFICE skills including proficiency with MS office applications including MS Excel, Word, Outlook, PowerPoint and database management. Apply Now! \| Send job to a friend Administrative Assistant (Ref#AA0108BL) The Administrative Assistant will provide administrative support to the Sr. Director of Clinical Operations and the Clinical department. Provides analytical and specialized administrative support to relieve and assist executive, administrative, line and staff managers of complex details and advanced administrative duties. May handle special projects and execute research and data analysis tasks. Analyzes problems, determines approach, compiles and analyzes data and prepares reports and recommendations. Coordinates activities between departments and outside parties. Contacts company employee's at all organizational levels to gather information and prepare reports. Work is generally of a critical or confidential nature. Assignments may be in various functional areas. The ideal candidate will have at least a high school diploma and a minimum of 5 years in an administrative assistant role supporting multiple people. The position requires strong proficiency in Word, Excel and PowerPoint (Livelink is a plus.), good presentation, communication skills, and the ability to adapt to an ever changing environment. The ideal candidate must be able to work with executives and their assistants. Biotech/ Pharmaceutical experience preferred. Apply Now! \| Send job to a friend