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Job Postings 2018-04-19T20:12:08+00:00

Join Our Team.

We seek highly motivated professionals to join our team. We invite you to schedule a visit through Human Resources to learn more about our company and see our current open job postings below.

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Administrative

Reporting to Executive Vice President Chief Financial & Administrative Officer, this position will support the daily administrative needs of a biotech organization.

List of Responsibilities and Job Duties

Assist EVP Chief Financial & Administrative Officer:

  • Requires a thorough knowledge of company operations, policies and procedures.
  • Handles details of a highly confidential and critical nature.
  • Strong professional demeanor and presence.
  • Global travel experience in solving issues or concerns.
  • Collects and prepares information for use in discussions/meetings of executive staff and outside individuals.
  • Prepares accurate and timely presentation materials for board of directors meetings.
  • Makes high-level contacts of a sensitive nature both inside and outside the company.
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
  • Analyzes problems, determines approach, compiles and analyzes data and prepares reports and recommendations with an extremely high level of accuracy, attention to detail and timeliness.
  • Coordinates activities between departments and outside parties.
  • Contacts personnel at all organizational levels to gather information and prepare reports.
  • Works on assignments that are extremely complex in nature, in which independent action and a high degree of initiative are required in resolving problems and developing recommendations.
  • Acts independently and proactively to determine methods and procedures on new assignments and may supervise the activities of other non-exempt personnel.
  • Other projects as assigned.

Desired Skills and Experience:

  • Ideal candidate will have 15+ years of top-level EA experience, supporting C-level Executives, perhaps as a paralegal or preferably with a VC partner or executive of a biotech or pharmaceutical company.
  • Ideal candidate will display a willingness to handle all assigned duties with a grace and aplomb.
  • Must possess excellent written and verbal communication skills.
  • Available as needed. Positive high energy can do attitude a must.
  • Requires specialized administrative support experience, flexibility, multi-tasking capabilities, intermediate arithmetic sills, a high proficiency in written communications, the ability to use all automated office equipment, read difficult instructions and maintain written records.
  • Back up for Board materials and communications.
  • Advanced competency in all MS Office software applications, particularly Excel and PowerPoint, required.

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

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Clinical

Reporting to the Vice President of Clinical Development and Translational Medicine at ChemoCentryx the Clinical Department at ChemoCentryx is seeking an Associate Director/Senior Clinical Scientist (PhD, PharmD or MD degree required, title dependent on the level of experience) to support the Clinical Development activities for a number of robust and innovative drug development programs (Phase 1-3). Experience with clinical trials in an established industry organization is a must, and experience or training in immunology or cancer-related research is highly preferred. The candidate will be able to work in a highly scientific and vibrant clinical research environment, join at a time of substantial growth of the organization, and have the opportunity to get exposure to a wide spectrum of clinical pharmaceutical development activities.

The Associate Director/Senior Clinical Scientist will work independently with appropriate supervision of the VP of Clinical Development and Translational Medicine, in responsibilities associated with all aspects of design, setup, and analysis of Phase 1 – 3 clinical trials, write up of scientific or regulatory documents or publications, and the support of monitoring activities where appropriate. The candidate will have excellent analytical and communication skills, and the ability to interact effectively with internal stakeholders including Clinical Operations, Regulatory and Clinical Pharmacology, as well as with study investigators and their staff, CROs and vendors operating on behalf of ChemoCentryx. The individual may also be involved in other activities in the department including clinical plan development, potential partnering discussions, regulatory meetings, departmental meetings, planning and preparation for scientific meetings, staff training, and patient recruitment initiatives. The candidate is expected to work independently and efficiently in a dynamic, fast-pace work environment of a rapidly growing organization and deliver the highest standard of quality work.

Responsibilities:

  • Work closely with the VP of Clinical Development and Translational Medicine and the Clinical Science team, to interface internally and externally as the primary clinical science lead of assigned studies and programs.
  • Design, author and review clinical protocols, protocol amendments, informed consent documents, CRFs, monitoring plans, data analysis plans, interpretation of results, clinical study reports, and supporting work for sections of regulatory submissions, such as, INDs, CTAs, NDAs, MAAs and regulatory agency briefing packages, etc.
  • Will be actively involved in planning, preparation and participation of regulatory meetings, e.g., End-of-Phase 2 meeting or other regulatory adhoc meetings.
  • Prepare, present, and defend complex aspects of protocol design and/or study data at investigator and internal meetings.
  • Responsible lead for the scientific execution and monitoring of the clinical trials under appropriate supervision hereby partnering closely with representatives of Clinical Operations, Regulatory Affairs, Clinical Pharmacology, etc.
  • Closely collaborates with clinical trial investigators and key opinion leaders during all phases of the clinical trial and program.
  • Prepare and review draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators.
  • Assist in researching, drafting and authoring of sections or entire documents, as assigned, such as clinical study reports and documents, investigator brochures, etc.
  • Critically analyze and synthesize complex information from reviews of the scientific/clinical literature.
  • Excels working in cross-functional teams as the science lead together with representatives of Clinical Operations, Regulatory, Biometrics, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
  • Includes travel up to 30% at times..

Required Skills and Experience:

  • Requires a PhD, PharmD or MD degree required with a minimum of 5 years of pharmaceutical/biotech industry experience.
  • Experience in one or more of the following area(s) is desirable: Immunology, oncology, nephrology, and rheumatology.
  • Has routinely developed, authored and reviewed Clinical Study protocols, Informed Consent forms, CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, and other regulatory documents.
  • Has successfully conducted clinical trials in a GCP/ICH compliant environment in a cross-functional team environment including representatives of Biometrics, Clinical Operations, Regulatory, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
  • Has applied important concepts associated with the clinical development process, e.g., clinical trial design, randomization, masking, data collection, quality control, basic statistical methodology supporting study design, data interpretation and presentation and publication.
  • 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 scientifically robust and defendable conclusions.
  • Has advanced the development strategy of clinical programs and pivotal clinical trials.
  • 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 lead protocol-related discussions (e.g. entry criteria of the protocol) with representatives of clinical operations, investigators and investigators 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.
  • Prior training and work in an environment applying Good Clinical Practices (GCPs) is necessary.
  • Has outstanding ability to present and communicate 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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We currently seek an innovative Scientist to join our Biology Group to independently propose and lead innovative research efforts focused on Immunology, Cancer Biology or related field. The title is flexible and will be commensurate with the candidate’s background and experience.

ChemoCentryx is offering a unique opportunity for a highly motivated researcher to join our team focused on the discovering and developing orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer. The ideal candidate will have experience in immunology/cancer biology and immunology/cancer signaling pathways.

Job Responsibilities:

  • Provide foundational expertise in immune/cancer biology to evaluate and propose innovative immune oncology strategies and targets.
  • Ability to conceive/propose, develop/evaluate biochemical and cellular assays to probe target biology.
  • Make detailed observations, analyze data and interpret results.
  • Ability to identify, develop and optimize new methods/assays to generate reliable and reproducible data in a timely manner.
  • Make detailed observations, analyze data and interpret results.
  • Experience in cell isolation/manipulation is required, and a proven background in primary and recombinant cellular assay development.
  • Design and execution of experiments in animal models relating to autoimmune disorders and cancer.
  • Work collaboratively in a fast paced, entrepreneurial environment with project teams composed of Biology, Medicinal Chemistry, Pharmacology and Toxicology teams.
  • Proficiently articulate research results for internal and external presentations/publications.

Required Skills and Experience:

  • The successful candidates will have a Masters or PhD in Immunology, Cancer Biology or related field and have completed minimum of 2 years of post-doctoral training.
  • Minimum of 2-4 years’ experience in the biopharmaceutical industry highly preferred.
  • Experience in cellular and molecular biology, flow cytometry, immunohistochemistry and tissue culture desired.
  • Demonstrated record of accomplishment of independent critical thinking and scientific achievement in the immunology and/or oncology.
  • Working knowledge in both in vitro and in vivo tumor biology is a plus.
  • Proficiency in designing and executing a variety of in vivo tumor model.
  • Proven record of accomplishment of publication in high impact scientific journals required.
  • Excellent verbal, written and problem-solving skills are required.
  • Previous experience of working with human cells/tissues.
  • Demonstrated scientific productivity as evidenced by a strong record of publications, patents, and/or pipeline accomplishments.
  • Strong history of publication in top tier scientific journals.
  • Outstanding written, visual, and oral communication skills.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

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

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This position will be primarily responsible for designing and conducting DMPK & clinical pharmacology studies to solve DMPK related problems for drug discovery and development projects. The incumbent will serve as a DMPK representative on drug discovery projects to identify the DMPK issues of the SAR compounds, investigate the causes for these issues, and guide medicinal chemists to improve the DMPK properties of the SAR compounds. The incumbent will also work with the clinical team to design the clinical PK and clinical pharmacology studies, interpret the clinical PK results, and participate in the production of the documents (such as study reports and CTD modules) for regulatory submissions.

Qualifications/Experience:

  • PhD degree in pharmacokinetics, biochemistry, organic chemistry or a relevant field
  • 3 – 10 years of experience with DMPK in the drug discovery or development environment
  • Hands-on experience with LC-MS/MS bioanalysis and in vitro ADME assays
  • Deep understanding of principles of pharmacokinetics and causes for DMPK problems
  • Expertise in solving DMPK problems for medicinal chemistry SAR programs
  • Expertise with PK software programs such as WinNonlin Phoenix
  • Experience with PK modeling programs such as NLME or NONMEM is a plus
  • Excellent oral and written communication skills
  • An excellent team player

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

Submit Resume

Reporting to the Vice President of Clinical Development and Translational Medicine at ChemoCentryx the Sr. Director of Clinical Operations with 10+ years of solid clinical-operational trial experience will head, direct, manage and develop a team of operational professionals and be responsible for developing & implementing the clinical operational strategy. A core responsibility is to direct clinical operations activities and decisions including quality, timelines, resourcing, budget planning and expenditures related to the conduct of clinical research programs and studies in accordance with applicable regulations, ICH/GCP guidelines and company Standard Operating Procedures (SOPs). This position is responsible for identification of clinical operations resourcing and management of staff including professional development, recruitment, retention and performance management. The individual is expected to work independently and efficiently in a dynamic, fast-pace work environment of a rapidly growing organization and deliver the highest standard of quality work.

Specific Responsibilities

  • Define the Clinical Operation strategic roadmap, setting goals & ensuring successful execution of the clinical team program & company goals
  • Identify data analytics needed to achieve overall goals & track performance against key metrics.
  • Perform workflow analysis to monitor consistency & efficiency in processes & procedures & identify & re-design inefficient workflows & gaps within Operations processes.
  • Ensure compliance with all requirements according to ICH/GCP, organizational SOPs & organizational requirements.
  • Develop, review and implement departmental SOPs and processes and maintain oversight to ensure compliance
  • Oversight and flawless execution of all facets of the clinical trial processes, hereby ensuring
  • Consistency of process across clinical programs and study teams
  • Implement process changes around operational gaps within current operations processes
  • Represent the primary point of contact to Sr. Management and to external operational business partners, vendors and CROs.
  • Along with other Clinical Development personnel, represent the organization externally to Investigators and trial site administrators
  • Represent Clinical Operations on cross-functional project teams and operational meetings where required
  • Build, manage and direct team of CTM/CRAs and other resources within Clinical Operations
  • Responsible for cross-functional management, CRO/vendor selection, management and oversight Resource allocation across studies and resource allocation of clinical operations resources across programs

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

Submit Resume

Reporting to the Vice President of Clinical Development and Translational Medicine at ChemoCentryx the Clinical Department at ChemoCentryx is seeking an Associate Director/Senior Clinical Scientist (PhD, PharmD or MD degree required, title dependent on the level of experience) to support the Clinical Development activities for a number of robust and innovative drug development programs (Phase 1-3). Experience with clinical trials in an established industry organization is a must, and experience or training in immunology or cancer-related research is highly preferred. The candidate will be able to work in a highly scientific and vibrant clinical research environment, join at a time of substantial growth of the organization, and have the opportunity to get exposure to a wide spectrum of clinical pharmaceutical development activities.

The Associate Director/Senior Clinical Scientist will work independently with appropriate supervision of the VP of Clinical Development and Translational Medicine, in responsibilities associated with all aspects of design, setup, and analysis of Phase 1 – 3 clinical trials, write up of scientific or regulatory documents or publications, and the support of monitoring activities where appropriate. The candidate will have excellent analytical and communication skills, and the ability to interact effectively with internal stakeholders including Clinical Operations, Regulatory and Clinical Pharmacology, as well as with study investigators and their staff, CROs and vendors operating on behalf of ChemoCentryx. The individual may also be involved in other activities in the department including clinical plan development, potential partnering discussions, regulatory meetings, departmental meetings, planning and preparation for scientific meetings, staff training, and patient recruitment initiatives. The candidate is expected to work independently and efficiently in a dynamic, fast-pace work environment of a rapidly growing organization and deliver the highest standard of quality work.

Responsibilities

  • Work closely with the VP of Clinical Development and Translational Medicine and the Clinical Science team, to interface internally and externally as the primary clinical science lead of assigned studies and programs
  • Design, author and review clinical protocols, protocol amendments, informed consent documents, CRFs, monitoring plans, data analysis plans, interpretation of results, clinical study reports, and supporting work for sections of regulatory submissions, such as, INDs, CTAs, NDAs, MAAs and regulatory agency briefing packages, etc.
  • Will be actively involved in planning, preparation and participation of regulatory meetings, e.g., End-of-Phase 2 meeting or other regulatory adhoc meetings
  • Prepare, present, and defend complex aspects of protocol design and/or study data at investigator and internal meetings
  • Responsible lead for the scientific execution and monitoring of the clinical trials under appropriate supervision hereby partnering closely with representatives of Clinical Operations, Regulatory Affairs, Clinical Pharmacology, etc.
  • Closely collaborates with clinical trial investigators and key opinion leaders during all phases of the clinical trial and program.
  • Prepare and review draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators
  • Assist in researching, drafting and authoring of sections or entire documents, as assigned, such as clinical study reports and documents, investigator brochures, etc.
  • Critically analyze and synthesize complex information from reviews of the scientific/clinical literature</li
  • Excels working in cross-functional teams as the science lead together with representatives of Clinical Operations, Regulatory, Biometrics, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc,
  • Includes travel up to 30% at times.

Required Skills and Experience

  • Requires a PhD, PharmD or MD degree required with a minimum of 5 years of pharmaceutical/biotech industry experience.
  • Experience in one or more of the following area(s) is desirable: Immunology, oncology, nephrology, and rheumatology.
  • Has routinely developed, authored and reviewed Clinical Study protocols, Informed Consent forms, CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, and other regulatory documents.
  • Has successfully conducted clinical trials in a GCP/ICH compliant environment in a cross-functional team environment including representatives of Biometrics, Clinical Operations, Regulatory, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
  • Has applied important concepts associated with the clinical development process, e.g., clinical trial design, randomization, masking, data collection, quality control, basic statistical methodology supporting study design, data interpretation and presentation and publication.
  • 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 scientifically robust and defendable conclusions.
  • Has advanced the development strategy of clinical programs and pivotal clinical trials.
  • 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 lead protocol-related discussions (e.g. entry criteria of the protocol) with representatives of clinical operations, investigators and investigators 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.
  • Prior training and work in an environment applying Good Clinical Practices (GCPs) is necessary.
  • Has outstanding ability to present and communicate 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.

Submit Resume
We seek someone with demonstrated strength and success in project and program management to plan and execute on clinical stage therapeutic candidates. The candidate will plan and direct critical schedules and budgets and will ensure effective outcomes throughout all phases of a project. The Manager will drive the development of high-quality and integrated cross-functional plans in support of our projects. This person will be responsible for project performance, risk management, administration, financial management and issue resolution for the functioning group. The successful candidate applies best practices in the development, initiation, planning, execution, control and closing of projects.

  • Oversees program plan development, tracks and updates milestones and key activities
  • Establishes and maintains integrated project schedules to ensure accurate project, financial and portfolio analyses; aligns with functional partners and project sub-teams
  • Collaborates with Clinical, Finance and Research and Development in the preparation of budgets, other resources and costs.
  • Develops detailed project plans, milestones, timelines and corrective action.
  • This person must build strong working relationships across departments, with key stakeholders and senior management.
  • Effectively communicates with all levels within the organization, documents and maintains project team outcomes, activities and decisions.
  • Facilitates project team meetings, cross-functional information sharing and ensures alignment.
  • Balances conflicting priorities across multiple objectives or programs and has the ability to articulate risks and trade-offs.
  • Manages and can operationalize a set of alliance partnerships to drive their success and growth.
  • Builds and maintains strong relationships with a diverse set of internal and partner contacts, including senior level executives.
  • Facilitates ongoing communication to understand key interdependencies, drive decision-making, issue resolution and execution across collaborations, as well as keeping all stakeholders informed and up to date on collaboration details.
  • Performs other duties as required.

Title and reporting structure is commensurate with experience.

Who We Seek

  • BS or BA in Life Sciences. An advanced degree, MS,MBA or Ph.D.is preferred; however experience and accomplishment will be considered in lieu of advanced degree.
  • The preferred candidate would have a PhD in chemistry, biology or biomedical engineering with excellent working scientific knowledge of all areas. He/she would have several years’ experience in biotech industry project management, particularly at the early and Phase 3 development stage and would have worked within the context of an active industry alliance
  • Multidisciplinary knowledge of biotechnology/pharmaceuticals
  • 5 years-experience in project management in support of drug development
  • PMP and other certifications preferred
  • Ability to establish and maintain positive relationships with partners at all levels and across various disciplines.
  • Expertise and accomplishment in drug development methodology, to include project management practices, methodology and tools
  • Proven results in managing strategic alliance partnerships that have generated significant revenue through sell-with and sell-through models.
  • Has financial acumen; can plan and manage budgets; metrics
  • Excellent management, leadership and interpersonal skills
  • Attention to detail, action oriented and outcome focused
  • Strong written, verbal and platform skills
  • Experience in using project management software to manage budgets, timelines and outcomes

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

Submit Resume

Regulatory

Summary

Contractor Regulatory Affairs Associate, with a focus on clinical and nonclinical aspects, will participate as a member of the regulatory team in the development and implementation of global regulatory strategy worldwide for products serving patients with rare diseases and unmet medical needs. This individual will be responsible for assisting with the development and coordination of regulatory submissions, with input from cross-functional team members, to support regulatory filings, agency meetings, and overall program priorities.

Responsibilities

Responsible for organization of cross-functional activities pertaining to regulatory function, including the development of meeting requests, timelines, and compilation of briefing documents intended for submission to regulatory authorities.

  • Actively participate in regulatory meetings on defined topics with a clear objective. Author and archive meeting minutes.
  • Maintain regulatory dossiers in compliance with global health authority requirements.
  • Participate in the development of regulatory submissions for assigned products and regions.
  • Interact with other global project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
  • Interact with internal and external partners as necessary to support product development.
  • Conduct and analyze regulatory research to understand past precedence and the current competitive landscape.
  • Educate internal stakeholders on implications of regulations.
  • Provide logistical support for meetings with US and ex-US regulatory agencies.
  • Support the preparation of responses to questions and comments from regulatory agencies.
  • Support the filing and archival of regulatory documents, study reports, etc.

Experience

Required Skills:

  • Minimum 4 years of regulatory affairs experience or equivalent combination with advanced degree.
  • Understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Experience with global regulatory dossiers desirable.
  • Excellent written, verbal, and organization skills, with strong attention to detail.
  • Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate cross-functionally in a collaborative manner.
  • Preferred experience with eCTD document formatting and publishing, and the use of regulatory authoring templates.

Education

Bachelor’s degree required. Prefer life sciences or related major.

Contract for 1-6 months.

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