Jobs That Crossed My Desk, Feb. 9-20 , 2009
Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.
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If interested,
Please contact Patti.
Patti Henderson-O'Connell
President/Owner
O'Connell Search International
17106 Vose St.
Lake Balboa, CA 91406
818-675-6465
I have a new opening for Surgi-Vision in Irvine. Electrical Engineer
BS or MS up to 160K depending on experience--must have Medical Device
and RF experience--- MRI and Catheter experience a plus. Very strong
Technically. Please let me know if you would be interested or know of
someone who may be
Send Resumes to Thomas Schmid
Phone 877-258-7724 ext 105
Position Location: San Francisco
Thomas Schmid
Senior Recruiter
Office: 760-547-2177 ext 105
Toll Free: 877-258-7724
Fax: 877-231-9771
www.bluechipsearch.com
kedin.com/in/tschmid949
Director, Business Development / Sales
Our client is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. The company meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle.
Currently, we are experiencing significant growth and are conducting a search for sales candidates in the San Francisco area.
Reporting directly to the Senior Director within our Business Development Department, the Business Development Director's primary responsibilities will include the following:
· Building and executing business plan for achieving quarterly and annual revenue and pipeline objectives
· Identification and prospecting of new business leads, including qualification and needs assessments
· Presentation and positioning of marketing and sales solutions to prospective client executives (outsourced professional services)
· Developing effective proposals and persuasively closing new business opportunities
· Maintaining client relationships and building new business relationships
· Management of territory and named accounts
· Strategic ability to identify needs and problem solve for clients
· Coordination with regional director, project teams, and team leads/project managers
· Coordination with business groups for staffing and proposal/project development
· Identification of up-sell opportunities
· Provide lead generation and RFP generation
The successful candidate will have a combination of the following skills/experience:
· Living in SF/Bay area (preferred)
· BA/BS degree required (Business or Life Science related degrees preferred)
· Minimum of 5-7 years professional experience selling software and/or services into the Life Science Industry (Pharmaceutical, Biotech, Clinical Research)
· SF.com knowledge a plus
· Knowledge of all MS Office applications required
· Excellent written and oral communication skills
· Self motivated determined individual with a track record for success
· Strong sales skills & ability to work with CXO-level executives
· Willingness to travel up to 100%
The company is an Equal Opportunity Employer with an outstanding corporate culture. We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities. The entrepreneurial setting, coupled with our financial stability, has made them an employer of choice, and one of the most sought after Life Sciences employers in the area.
Contact
Jarboe & Associates
(office) 970-669-2600 970-689-2962 (mobile
not listed - OPPORTUNITIES FOR MEDICAL DOCTORS - please call for details
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Senior Scientist lll– Clinical Pharmacokinetics (full description available soon-please contact) Texas
Requires a Master's and 9 years of experience or a PhD and 6 years experience.
Must be familiar with and very comfortable with NONMEM, simulation, PK modeling
Associate Director / Clinical Team Leader, Clinical Pharmacokinetics Texas
Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential
Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis.
Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental company personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives.
Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products.
Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives.
Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies.
Submits and administers employee performance standards and actively develops personnel within the team.
Provides timely and quality documents (i.e., protocols, clinical study reports (Scars), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects.
Represents Clinical Pharmacology at various clinical meetings and project team meetings.
Principle Responsibilities:
Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with company PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and R&D objectives.
Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.
Provide effective and timely mentoring and support for subordinates.
Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.
Additional (enhancing) skills:
Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation. Familiarity with relevant company SOPs and document management systems. Good knowledge of GCP requirements. Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. Excellent written and oral communication skills.
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Associate Director, Regulatory Affairs__________________________________________________________Illinois
Responsible for representing the department on project teams, and collaborating on the development of regulatory strategies (e.g., NDA/BLA strategy) with management oversight; driving submission related activities and successfully executing regulatory strategies. Responsible for significant interactions outside the Regulatory Affairs department on complex issues including interaction with regulatory authorities.
Position Requirements: *Bachelor's degree in scientific discipline; advanced degree preferred. *At least 8-10 years industry experience, 6 years in Regulatory Affairs preferred. *Recognized as experienced in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope. *Scientific knowledge in chemistry, general biology/physical sciences, or health sciences, and ability to apply knowledge to regulatory issues and pharmaceutical product development and to deal with in-depth technical information from a variety of disciplines. *Comprehensive knowledge of the drug development process and life cycle management and application to current and evolving regulatory requirements associated with assigned products and therapeutic/technical areas. This should also include experience with global regulatory projects. *Strong organizational skills with the ability to manage multiple complex projects in a matrix environment. *Excellent written and verbal communication skills. Ability to communicate effectively with peers, technical experts, scientists, senior staff, and regulatory authorities to present scientific/regulatory case and foster high degree of credulity with regulatory authorities *Experience managing others preferred.
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Clinical Program Manager (Anemia)____________________________________________________ California
Description:
*Reporting to the Associate Director, manage the implementation of clinical studies to ensure that they are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines *Coordinate and oversee the internal activities for each study in terms of clinical, data management, biometrics, drug safety, regulatory, and clinical supplies activities *Write clinical trial protocols and amendments *Manage the preparation of Informed Consent Forms *Assist in the design and development of and approval of Case Report Form development *Coordinate team review of tables, figures, and listings *Working with Clinical Contracts and Outsourcing, select service providers, review and approve of site and service provider budgets and scope of work
Oversee management of service provider activities including CROs, contract regional CRA monitors, data management, biometrics, central and specialty laboratories, and IWRS/IVRS *Address and seek resolution of administrative issues with investigational sites or service providers. *Escalate issues to the Associate Director as needed *Manage service provider budgets and invoices *Directly manage in-house CRAs in terms of administrative and project performance *Forecast and manage the investigational product needed for the conduct of clinical trials *Manage and ensure investigational product accountability *Develop clinical monitoring plans and establish study monitoring priorities *Develop and maintain cross-functional study timelines using MS Project *In partnership with the Associate Director, Medical Monitor, Biostatistician, and Drug Safety, assist in the preparation of Clinical Study Reports, product Investigator Brochure, IND Annual Reports, expedited or annual safety reports
Job Requirements:
A minimum of 7 years of experience as a CRA in a pharmaceutical or biotechnology company with the first five years of progressive CRA responsibilities and at least the last two years in a management role *Knowledge of FDA regulatory requirements and competence in ICH/GCP guidelines *Knowledge of clinical trial methodology *Demonstrated proficiency in the implementation, maintenance, and closure of clinical trials *Demonstrated managerial and supervisory skills
Demonstrated ability to work effectively with cross-functional project team members (regulatory affairs, QA, marketing/business *development, research, project management, etc) *Excellent written and oral communication and analytical skills *Demonstrated experience in managing international studies; experience with East Asia a plus *Computer proficiency in MS Word, Excel, Project, Power Point, and Outlook; MS VISIO a plus
Education:
Bachelor's degree in a scientific or health-related field
Languages:
English - excellent command of English, written, oral and in presentations
Mandarin – Ability to speak, write and type a plus
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Senior Clinical Contracts Associate_________________________________________________________California
Responsibilities:
The Senior Clinical Contracts Associate's primary responsibilities shall include but are not limited to the preparation, negotiation, tracking and finalization of the clinical trial agreements and confidentiality agreements inclusive of the site budget within the clinical trial agreement.
This position reports to the Associate Director, Clinical Contracts and Outsourcing.
Specific duties ? Draft and track status of clinical trial agreements, amendments and confidentiality agreements with site specific information and e-mail to sites ? Status the sites regarding outstanding agreements and budgets, and provide weekly updates to clinical team ? Process all agreements for execution, ensuring that the appropriate departments within company receive a copy
? Ensure that all budget approvals, correspondence, invoices and fully executed contracts are filed within the clinical contracts filing system and ensure files are audit ready ? Track all fully executed clinical agreements and invoices
? Update the financial spreadsheets for each study/site ? Liaise with clinical for monthly site accruals ? Pay, track and reconcile all payments to investigator sites ? Responsible for the development of site budget templates from the Schedule of Assessments ? Negotiate directly with the sites regarding budgets and contract language ? Liaise with legal for review of contract language ? Mentor Clinical Contract Associates and may have a supervisory role ? Ability to negotiate global clinical trial agreements and budgets ? Ability to establish, draft and train with respect to process documents
Requirements: ? BS/BA in Business Administration, finance or related discipline, or equivalent education plus experience ? At least four (4) years of site budget and contract negotiation experience ? Minimum of 5-7 years of experience in a contract administration environment in a pharmaceutical, CRO or biotech company ? Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts (healthcare compliance, GCP, CFR) ? Excellent negotiation and written/verbal communication skills ? Ability to work independently, creative thinking and problem solving skills ? Ability to understand the full clinical development process ? Must understand the "Sponsor of Choice" philosophy ? Must have good organization and planning skills, proven ability to handle multiple priorities and work independently ? Must be a team player and be a leader within the department ? Proficiency with MS Word, Excel, Access and Outlook required
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Senior Clinical Research Associate_____________________________________________________ ___California
The Sr. Clinical Research Associate (CRA) will be responsible for initiation, monitoring and other tasks associated with clinical studies. The Sr. CRA will also be responsible for investigational site management for clinical studies and will assist in the creation of an implementation of protocols, informed consents, case report forms, clinical study reports and related study materials. He/she will also provide guidance, clinical trial management and direction to contract CRAs in the field.
Responsibilities:
? The Senior CRA will actively participate in clinical trial activities from study start through closure ? Assist the CPM with vendor management, including the CRO (monitoring and data management), central laboratory and IVRS vendors ? Work with CRO and manage site selection process ? Assist with reviewing and editing study documents such as Study Operations Manual, Study Drug Manual, Project Management Plan, Communication Plan, Monitoring Plan and Data Management Plan ? Prepare and review study tools such as Source Document Worksheets and Source Data Verification Worksheets ? Assist with protocol development, study design completion and designing CRFs ? Accompany CRO/CRAs to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols ? Order and coordinate study supplies ? Develop and maintain tracking tools ? Assist with CRO selection and management of CROs and other vendors ? May assist with site budget negotiations ? Plan and participate in investigator meetings ? Assist and support data validation and data clean procedures
? Assure regulatory compliance of investigational sites with SOPs and FDA and ICI guidelines
Requirements: ? BS in Life Sciences or health-related field ? Minimum of 5 years experience as a CRA including monitoring of sites and in-house CRA study management ? Minimum of 2 years in-house experience ? Some experience in protocol writing and informed consent development ? Experience in study site selection, site budget development / negotiation and overall site management ? Some experience in vendor (CRO, central laboratory, IVRS, EDC) selection and overall vendor management (CROs and preferably IVRS) ? Willing to travel as needed (Minimal travel)
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