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Job Postings2019-02-21T16:39:13+00:00

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Clinical

Summary/Objective:

Working within internal functional partners, external contract development organizations and selected consultants, this individual is responsible for the development and overseeing the execution of technical activities associated with late stage product development and manufacturing in support of clinical development, regulatory filings and product commercialization.

Key individual and leader of the team responsible for manufacturing, packaging and release of commercial products by the Contract Manufacturing Organizations. Additionally, this individual will support the manufacturing and release of the Drug Substance and Regulatory Starting Materials by the CMO’s.

Specific Responsibilities:

  • Oversees program plan development, tracks and updates milestones and key activities
  • Working with PD management and other internal partners, establish and track progress in the execution of the technical drug product strategies in support of NDA/MAA filings, product approvals and commercialization
  • Responsible for providing project management and technical expertise to late phase CMC activities, in particular with those activities associated with drug product manufacturing, packaging and release.
  • Responsible for providing technical expertise to all the GMP activities associated with the outsourcing the development and manufacturing of drug substance, starting materials, analytical development formulation and manufacturing process for product in late development and during commercialization.
  • Responsible for overseeing the manufacture of clinical trial materials at the selected CMO
  • Responsible for overseeing the manufacturing packaging and release of commercial products
  • Working closely with the QA organizations provide solid input in the resolution of issues associated with the manufacture and release of clinical supplies and commercial products
  • Working closely with QA responsible for the development and maintenance of an accurate inventory of the Clinical Supplies and commercial product
  • The scope of the responsibility is from IND, Phase 1, 2, 3 to NDA filing and approval and during the commercialization of CCXI products.
  • The Associate Director participates in all projects and manages multiple program collaborating with the CCXI following groups: Process Chemistry, Biology, DMPK, Pre-Clinical, Outsourcing, Clinical Operations, Quality, Finance and Regulatory Affairs.
  • The Associate Director will support project management in all technical activities associated with all development programs and product in commercialization
  • Facilitates the design and implementation of initiatives with the CMO’s that improves business performance
  • Able to develop a strong background in performance metrics and reporting for business review meetings with the CMO’s
  • Follows up and drives the closure of action items from the team meetings and business review meetings
  • The Associate Director should have significant knowledge, experience and skills with compliant Quality Management Systems in support of Product Development and overall CCXI business
  • Collaborating with CCXI Quality Organization, establishes, oversees, expand and maintains a SOP’s related to Pharmaceutical Development.
  • Leads continuous improvement efforts in quality systems and department infrastructure (including documentation) through the evaluation of current organizational process, audit feedback, and previous experience
  • Develops plans and implements actions to ensure readiness for regulatory and audit inspections.
  • Works closely with QA to support the review and approval of batch record, validation, specification and change control documentation produced by CMOs and CROs.
  • Working closely with PD management and QA 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 documentations specific for each CMO and each product related to outsourced operations (e.g. contractor manuals)
  • Performs CMC technical audits potential CMO’s to ensure technical capabilities, compliance to relevant regulations
  • Provides support for the oversight of site technical validation activities (analytical, manufacturing, etc).
  • Assists in the preparation and review of regulatory submissions for USA and worldwide heath agencies.
  • Provide technical support during external audits of vendors and subcontractors
  • Principal author of Contract Manuals

Requirements:

  • BS, MS or PhD scientific degree with a minimum of 10 years of technical and direct product development experience for late stage Product Development and during product commercialization
  • Candidate should be considered an expert in late stage small molecules product development with proven technical experience in one or more of the following areas: Process Chemistry and manufacturing scale-up for drug substance, analytical method development for drug substance and drug product formulation and manufacturing process for Phase III and commercial drug product.
  • Proven experience as it relates to managing and interaction with CMO’s from early through late drug product development
  • Program Management skills highly desired.
  • Experience in authoring CTD sections as they relate to drug substance, drug product, analytical chemistry and specification settings in support of IND’s, NDA’s, MAA’s and IMPD’s
  • Deep knowledge of the GMP regulations requirements in product development manufacturing and release of clinical and commercial products
  • Proven track record in strategic planning for late stage development programs. Commercial experience highly desired.
  • Must have strong regulatory compliance working knowledge including FDA, cGXP, etc.
  • Must be detail oriented with excellent prioritization, organizational and project management skills.
  • Superior analytical and problem solving skills.
  • Effective communication (written and verbal) skills.
  • Ability to travel up to 30%

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Summary/Objective
The Clinical Development Department at ChemoCentryx is seeking a Senior Medical Director who will be responsible for providing clinical leadership of clinical development programs, and for the design, execution, and analysis of clinical trials, as well as for supporting Medical Monitoring activities across trials. An MD degree is preferred; a degree of PharmD or PhD with equivalent experience and skills will also be considered. The Senior Medical Director will report to the VP of Clinical Development and Translational Medicine and will collaborate with other medical officers in the organization.

The Senior Medical Director has proven leadership skills and the ability to successfully guide and influence cross-functional teams. The individual collaborates with internal stakeholders such as Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Data management, Biostatistics as well as with external collaborators such as study investigators and their staff, Key Opinion Leaders, CROs and vendors operating on behalf of ChemoCentryx. The candidate will be able to work in a highly scientific and vibrant, fast-pace clinical research environment at an organization that is undergoing substantial growth, and have the opportunity to get exposed to a wide spectrum of clinical pharmaceutical development activities including the opportunity to support regulatory submissions such as an NDA.

Essential Functions
Essential functions and responsibilities include the following:

  • Leads project team strategy, scope, complexity, size, and deliverables, overseeing the development strategy, clinical development plan.
  • Leads the design, data collection, review, execution of clinical studies in support of product development, ensuring rigorous and compliant study conduct with current health authority regulations.
  • Directs, designs, authors and reviews clinical trial protocols, protocol amendments, informed consent documents, investigator brochures, CRFs, monitoring plans, data and statistical analysis plans, etc.
  • Authors and reviews sections of clinical study reports and regulatory submission documents, such as, INDs, CTAs, NDAs, MAAs, regulatory agency briefing packages, etc.
  • Supports the review, analysis and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
  • Responsible for the scientific execution as required for the initiation, conduct and medical monitoring of Phase 1-3 clinical trials
  • Prepares, presents, and defends complex aspects of protocol design and/or medical study data at internal meetings or investigator meetings
  • Actively engages in the planning, preparation and participation of regulatory meetings, e.g., Pre-IND-, End-of-Phase 2 meeting, or other regulatory meetings
  • Collaborates with external stakeholders such as study investigators and their staff, Key Opinion Leaders, CROs and vendors during all phases of the clinical trial and program.
  • Prepares and reviews draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators

Required Education and Experience

  • Proven leadership skills and ability to successfully guide and influence cross-functional teams.
  • Requires an MD degree with a minimum of 8-10 years of pharmaceutical/biotech industry experience. PhD or PharmD with equivalent experience and skills will also be considered.
  • Ability to develop and conduct complex clinical research programs independently. Has advanced the development strategy of clinical programs including pivotal clinical trials (Phase I-III).
  • Will be able to develop, author and review Clinical trial protocols, Informed Consent forms, CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, Safety Monitoring Plans, Development Safety Update Reports, and other regulatory documents
  • Has robust expertise in the review, analysis and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
  • Will be able to evaluate safety events (e.g. SUSARs, laboratory observation, etc.) and analyze in conjunction with similar events across clinical trials and programs. Will be able to closely collaborate with the Safety and Pharmacovigilance group and Medical Monitors at the CRO.
  • Experience in one or more of the following clinical area(s) is desirable but not a must: Immunology, oncology, nephrology, and rheumatology. Prior medical practice is a definite plus.
  • Deep understanding of Good Clinical Practices (GCPs) is necessary. Has successfully conducted clinical trials in a GCP/ICH compliant environment
  • Has demonstrated the ability to analyze, interpret, and present complex scientific clinical data to both subject matter (e.g. key opinion leaders) and non-subject matter experts and is able to draw medical and scientific conclusions
  • Has demonstrated solid understanding of biostatistics, trial planning and sample size generation in collaboration with the biometrics group
  • Has basic understanding of clinical pharmacology
  • Has worked directly with Clinical investigators and is able to provide leadership in protocol-related discussions (e.g. entry criteria of the protocol) with representatives of clinical operations, investigators and investigator trial staff
  • Has demonstrated scientific expertise in the presentation and publication process with a track record of publishing peer-reviewed scientific data, e.g., posters, oral presentations, review articles, and manuscripts
  • Can work well in a cross-functional team environment which includes representatives of Biometrics, Clinical Operations, Regulatory, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
  • Has outstanding ability to present and communicate medical or scientific clinical data in a clear and concise manner
  • Has excellent business presence and demonstrated the ability to build/maintain relationships with internal and external stakeholders
  • Track record of creativity, high performance, and demonstrated ability to work independently and meet deadlines in a dynamic, fast-pace work environment and deliver the highest standard of quality work.
  • Excellent verbal and written skills along with the ability to work collaboratively in a dynamic and creative environment is essential

We participate in E-Verify, the US Government sponsored right-to-work verification process.

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