ChemoCentryx, a pharmaceutical company located in Mountain View, CA, seeks highly motivated professionals to join our team.
All ChemoCentryx employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts, and a comprehensive benefits package, including medical, dental and vision coverage and life and long-term disability insurance.
Please email your resume & cover letter to: firstname.lastname@example.org or FAX to: (650) 210-2910. No phone calls please. EOE
Associate Medical Director - Medical/Clinical Affairs
This Associate Medical Director level position requires the ability to work with supervision, in responsibilities associated with all aspects of design, setup, monitoring, and analysis of Phase 1 - 3 clinical trials. This person must have the ability to interact effectively with other members of the department, as well as with study investigators and their staff, CROs and vendors operating on behalf of ChemoCentryx. The individual is this position will also be required to be involved in other duties in the department including strategic planning, clinical plan development, potential partnering discussions, departmental meetings, planning and preparation for scientific meetings, staff training, and patient recruitment initiatives.
- Co-lead the CCX168 and CCX140-B clinical development programs in ANCA-associated glomerulonephritis and diabetic nephropathy, respectively; as such, participate in investigator outreach activities, design, placement, execution, data analysis, and report writing for the clinical trials, including Phase 1, Phase 2, and Phase 3 clinical trials.
- Medical monitoring of active clinical trials in the CCR2, C5aR, and CCR9 antagonist programs.
- Lead specific clinical trials, e.g., CCX168 Phase 1 and later stage clinical trials.
- Attend scientific meetings on behalf of CCXI to meet with investigators and key opinion leaders, submit and present abstracts.
- Organize and lead scientific advisory board meetings.
- Be actively involved in planning and preparation of Regulatory meetings and submissions, e.g., CCX168 End-of-Phase 2 meeting.
- Help mentor and guide other Department members.
- Participation in generation and critical review of study-related documents including study protocols, protocol amendments, investigator brochures, monitoring plans, informed consent documents, and CRFs.
- Includes travel up to 30% at times.
Education & Experience
Requires an MD with a minimum of 1 year of industry experience. Experience in one or more of the following area(s): Nephrology, rheumatology, internal medicine, or endocrinology desirable. Prior training and experience with Good Clinical Practices (GCPs). Excellent verbal and written skills along with the ability to work collaboratively in a dynamic and creative environment. Track record of creativity, high performance, and demonstrated ability to work independently and meet deadlines. Exhibits initiative, is proactive and able to contribute to overall medical and clinical development activities. This position requires attention to detail and the ability to interact effectively with other staff.
Reference Job Code: #012
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Director - Human Resources
Seeking Human Resources Director to manage the planning and implementation of HR strategies, programs, and initiatives to support the achievement of the company's short and long-term business objectives.
Some of the Key Responsibilities
- Partners with managers and senior management in all matters concerning Human Resources and People Management
- Develops annual HR Strategic Plan in conjunction with senior management
- Drives delivery of HR programs into the organization, including talent acquisition, staffing and selection, employment onboarding, compensation, training and development, talent management and succession planning, employee relations, AA/EEO compliance, and retention
- Helps to drive organizational effectiveness through Performance Management processes; improves manager and employee performance by identifying problems; evaluating, and implementing recommended solutions; coaching and counseling managers and employees. Assists with the delivery of training when needed
- Consults with department heads & senior management on organizational structures that will support and enable talent management, employee development, and building of capabilities to support the company's vision and strategic goals
- Ability to foster a positive team environment and build trusting relationships with employees
- Track record of success in achieving results
- Demonstrated success providing direct, complete, and actionable corrective feedback
- Effective communicator -- strong presentation and public speaking skills; able to write clear and succinct messages for a myriad of purposes and audiences
- Comfortable in fast-paced and dynamic organizations
- Experience in employee relations and performance management
Education and Experience
Bachelor's degree or equivalent, plus a minimum of 10 years progressively responsible HR experience. Experience in the Biopharmaceutical Industry highly desired.
Reference Job Code: CCX #017
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Scientist - Sr. Scientist, Biology
We currently seek a Scientist to join our Biology Group. The position requires a Ph.D. in Immunology, Cancer Biology or related field, with strong history of publication in top tier scientific. The title is flexible (Scientist - Sr. Scientist) and will be commensurate with the candidate's background and experience.
The successful candidate will have the following primary responsibilities:
- Lead independent research efforts into the basic biological functions of the chemokine/chemo-attractant receptor system(s).
- Provide internal and external presentations/publications to articulate research results, milestones, challenges, and plans.
- The successful candidates will have a PhD in Immunology, Cancer Biology or related field and have completed postdoctoral training.
- Minimum of 2 years' experience in the biopharmaceutical industry highly preferred.
- Experience with in vivo biological models necessary.
- Proven track record of publication in high impact scientific journals required.
- Excellent verbal, written and problem solving skills are required.
- Experience in multi-color flow cytometry preferred.
- Strong molecular biology experience is a plus.
- Experience in immunohistochemistry and tissue culture is desired.
- Previous experience of working with human cells/tissues is a plus.
- The successful candidate will enjoy working as a member of a fast-paced multidisciplinary project team in an entrepreneurial environment.
Reference Job Code: #020
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Senior Manager/Associate Director, Quality Assurance
Responsible for development, implementation and maintenance of quality assurance systems and activities. Oversees generation and review of documents used in cGMP, monitors audits of production and QC areas, and audits raw material vendors and prepare manufacturing documentation.
- Ensures compliant Quality Management System is established and maintained in compliance with applicable company and US/worldwide regulatory requirements, standards, guidance and procedures.
- Establishes, oversees and maintains a corporate, quality related SOP (CMC, Preclinical, Clinical) system.
- Leads continuous improvement efforts in quality systems and department infrastructure through the evaluation of trends in key performance indicators, audit feedback, and corrective and preventative actions.
- Provides cGMP guidance to internal departments for all phases of product development.
- Develops plans and implements actions to ensure readiness for regulatory and audit inspections.
- Directs QA support for the review and approval of batch record, validation, specification and change control documentation produced by CMOs and CROs.
- Oversees, the CMOs and CROs performance associated with the investigations and effective closing of all deviations and ensures that robust corrective actions are identified and quickly implemented.
- Establishes and maintains systems for the quality oversight of outsourced operations (e.g. contract manufacturers, contract laboratories), including but not limited to the disposition of bulk drug substance and drug product batches, review and approval of deviations, and maintenance of Quality Agreements.
- Performs audits of CMC, GLP and clinical contract facilities to ensure compliance to relevant regulations
- Provides support for the oversight of site validation activities.
- Assists in the preparation and review of regulatory submissions for USA and worldwide heath agencies.
- BS, MS or PhD degree with 5 to 10 years of direct QA and regulatory compliance experience.
- Deep knowledge and experience in quality assurance in a highly regulated environment.
- Proven track record in strategic planning for late stage development programs. Commercial experience desired.
- Must have strong regulatory compliance knowledge including FDA, cGXP, etc.
- Able to conduct external audits of vendors and subcontractors
- Must be detail oriented with excellent prioritization, organizational and project management skills.
- Superior analytical, problem solving and reviewing skills.
- Effective communication (written and verbal) skills.
- Ability to travel up to 30%
Reference Job Code: #019
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