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| Company: |
Sterling Life Sciences |
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| Job Title: |
Associate Director/Director of Clinical Operations |
| Job Category: |
Biotech |
| Job Location: |
San Diego - CA California - USA |
| Job Ref. Number for your records: |
2469 |
| Job Description: |
Our client is a biopharmaceutical company based in San Diego. The company focuses on in-licensing, developing and commercializing products pharmaceuticals to meet the needs of hospitalized patients and their care givers.
Job Responsibilities:
1) Manage clinical development program under the supervision of a Medical Director or VP
2) Manage the direction, planning, execution and conducting of assigned program
3) Ensure compliance with FDA regulations, GCP, ICH and company SOPs for all clinical operational activities
4) Manage NDA core team member for the organization and delegation of tasks related to clinical sections of the NDA, as well as the review/quality control of clinical sections
5) Coordinate ISS/ISE effort with assigned vendor
6) Provide leadership, guidance and direction for the Clinical Operations team, which includes managers, CRAs and assistants
7) Select and identify vendors, as well as assignment of personnel to participate in the monitoring of all aspects of clinical trial conduct (CRO management and oversight, contract CRAs and consulting staff, etc.)
8) Plan and host investigator and scientific advisory board meetings
9) Interact with key opinion leaders, therapeutic area experts and study staff
10) Establish and approve scientific methods for designing and implementation of clinical protocols, data collection systems, final reports and publications
11) Develop and manage strategic development plans
12) Establish, track and report appropriate performance metrics
13) Utilize metrics to manage continual improvement of the project
14) Manage and interact with senior leadership in regards to the project budgets and Investigators’/Vendor grants and contracts
Job Requirements:
1) Advanced degree in a medical or scientific discipline or equivalent experience
2) 5-7 years of experience in managing clinical studies and clinical programs in a pharmaceutical or biotechnological environment, with work history demonstrating progressive increase in level and breadth of responsibility
3) 3-5 years of successful managerial experience in leading teams
4) Therapeutic knowledge in the infectious diseases arena
5) Strong knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories and concepts to clinical drug development
6) Experience in communicating and negotiating with investigators and regulatory agencies
7) NDA, MAA or BLA experience
8) Expertise in GCP, FDA and ICH requirements
9) Strong presentation and interpersonal skills
Applicants are encouraged to apply directly by going to: Sterling life Sciences (job board)
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| Skills Required: |
Strong presentation and interpersonal skills
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| Language Requirements: |
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| Employment Type: |
Full Time
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| Yearly Salary: |
140 USD
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| Posting Date: |
Oct 19 2007 |
| Education level required: |
Bachelor
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| Experience (in years): |
3 to 5 Years |
| Company: |
Sterling Life Sciences |
| Contact Name: |
Sterling Life Sciences |
| Preferred Method of Contact: |
No Preference |
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