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Job Postings 2018-07-13T19:54:53+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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Administration

The Regulatory Affairs Associate, with a focus on clinical, nonclinical and CMC aspects, will participate as a critical member of the Regulatory team 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 development.

Must be highly detail oriented and an excellent proof reader.

Responsibilities:

  • Primary responsibility will be to compile and publish Regulatory submissions.
  • 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. Support the preparation of Sponsor’s Meeting Minutes from Regulatory Agency meetings. Maintain Regulatory dossiers in compliance with global health authority requirements.
  • Provide Regulatory support to ongoing clinical trials by coordinating with the provision of information from ChemoCentryx subject matter experts to ensure timely response to queries and comments from Regulatory Agencies and Ethics Committees. Interact with internal and external partners as necessary to support product development.
  • Support the filing and archival of Regulatory documents, study reports, etc.
  • Familiarity with the preparation of Regulatory Standard Operating Procedures (SOPs) and Work Procedures.

Required Skills:

  • Minimum 2-3 years of Regulatory Affairs experience.
  • Preferred experience with eCTD document formatting and publishing, and the use of Regulatory authoring templates.
  • Understanding of Regulatory requirements, including ICH guidelines and regional requirements for all territories. Experience with global Regulatory dossiers and filings 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 and in a collaborative manner.

Education:

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

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Supporting the CEO and COO. Reporting directly to the COO the Executive Assistant provides executive support in a one-on-one working relationship. The Executive Assistant serves as the primary point of contact for internal and external constituencies on all matters pertaining to the COO/CEO. The Executive Assistant also serves as a liaison to the board of directors and senior management team; organizes and coordinates external relations efforts; and oversees special projects. The Executive Assistant must be creative and enjoy working within a small, entrepreneurial environment that is mission-driven, results-driven. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, administrative, and organizational skills, and the ability to maintain a realistic balance among multiple priorities. The Executive Assistant will have the ability to work independently on projects, from conception to completion, and must be able to work under pressure at times to handle a wide variety of activities and confidential matters with discretion.

Roles and Responsibilities Executive Support:

  • Completes a broad variety of administrative tasks for the COO and CEO including: managing an extremely active calendar of appointments; completing expense reports; composing and preparing correspondence that is sometimes confidential; arranging complex and detailed travel plans, itineraries, and agendas; and compiling documents for travel-related meetings.
  • Plans, coordinates and ensures the COO and CEO’s schedule is followed and respected. Provides “gatekeeper” and “gateway” role, creating win-win situations for direct access to the CEO and COO’s time and office.
  • Communicates directly, and on behalf of the CEO and COO, with Board members, senior management team, and others, on matters related to CEO and COO programmatic initiatives.
  • Researches, prioritizes, and follows up on incoming issues and concerns addressed to the COO and CEO, including those of a sensitive or confidential nature. Determines appropriate course of action, referral, or response.
  • Provides a bridge for smooth communication between the CEO/COO office and internal departments; demonstrating leadership to maintain credibility, trust and support with senior management staff.
  • Works closely and effectively with the CEO/COO to keep him well informed of upcoming commitments and responsibilities, following up appropriately. Acts as a “barometer,” having a sense for the issues taking place in the environment and keeping the CEO/COO updated.
  • Provides leadership to build relationships crucial to the success of the organization, and manages a variety of special projects for the CEO/COO, some of which may have organizational impact.
  • Successfully completes critical aspects of deliverables with a hands-on approach, including drafting acknowledgement letters, personal correspondence, and other tasks that facilitate the CEO/ COO’s ability to effectively lead the company.
  • Prioritizes conflicting needs; handles matters expeditiously, proactively, and follows-through on all details.

Board Support and Liaison:

  • Serves as the CEO/COO administrative liaison to ChemoCentryx’s board of directors
  • Assists board members with travel arrangements, lodging, and meal planning as needed
  • Maintains discretion and confidentiality in relationships with all board member
  • Adhere to compliance with applicable rules and regulations set in bylaws regarding board and board committee matters, including advance distribution of materials before meetings in electronic/paper format. Senior Management Liaison
  • Participates as an adjunct member of the Executive Team including assisting in scheduling meetings and attending all meetings
  • Assists in coordinating the agenda of senior management team meetings and off-sites, and all staff meetings
  • Facilitates cross-divisional coordination of travel and outreach plans Communications, Partnerships, and Customers
  • In general edits and completes first drafts for written communications to internal/external stake holders.
    Strategic Initiatives
  • Works with the Strategic Initiatives team in coordinating the CEO/COO activities
  • Follows up on contacts made by the CEO/COO and supports the cultivation of ongoing relationships
  • Edits all, and creates acknowledgement letters from the CEO/COO.

Qualifications:

  • Strong organizational skills that reflect ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail
  • Very strong interpersonal skills and the ability to build relationships with stakeholders, including staff, board members, external partners.
  • Expert level written and verbal communication skills
  • Demonstrated proactive approaches to problem-solving with strong decision-making capability
  • Emotional maturity
  • Highly resourceful team-player, with the ability to also be extremely effective independently
  • Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast paced environment
  • Forward looking thinker, who actively seeks opportunities and proposes solutions Education and Experience Requirements
  • Bachelor’s degree preferred not required.
  • Strong work tenure:10-20 years ears of experience supporting C-Level Executives, preferably in a fast paced organization
  • Experience and interest in internal and external communications, partnership development, and special events
  • Proficient in Microsoft Office (Outlook, Word, Excel)

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Clinical

As VP, Medical Affairs, you will build and lead a headquarters and field-based medical team that will launch Avacopan, a first in class C5a receptor inhibitor for ANCA Associated Vasculitis. You will lead development and execution of a medical launch plan that will transform the treatment paradigm for people living with AAV. As part of CCXI’s first commercial team, you will provide medical and scientific leadership to enable the full potential of Avacopan and other CCXi drugs in development to make a difference in patient’s lives. Your contribution and leadership will be critical in helping the company achieve its objective of becoming a successful and fully integrated biopharmaceutical enterprise.

Main Responsibilities:

  • Recruit, develop and lead top-tier talent to serve as leaders and members of the CCXI Medical Affairs team.
  • Develop and execute a comprehensive Avacopan Medical Launch Plan that is aligned with the overarching brand plan.
  • Build a high-impact medical and scientific platform, including: scientific exchange and partnership with KOLs, medical communication and publication plans, scientific congress activities, medical education programs, scientific advisory boards and post-approval evidence generation plan (LCM).
  • Partner with cross-functional groups (e.g. Legal, Regulatory, Medical, Finance, HR) to ensure integration and consistency with professional business strategies and regulatory compliance of promotional materials.
  • Ensure all activities are conducted with the highest levels of scientific rigor and in full compliance with applicable rules and regulations.
  • Provide initial medical input for quality/ regulatory customer communications, technical bulletins and quality directives.
  • Support US clinical programs post-marketing commitments (if required) including clinical study protocol development and review, study execution, and study report development.

Skills and Abilities:

  • Understand the science and business of medicine and can speak both languages.
  • Strong communication skills, both written and verbal.
  • Knowledge of applicable regulatory, legal and compliance standards.
  • Demonstrated ability to work cross functionally.
  • High level of emotional intelligence along with ability to lead and inspire others.
  • Uphold impeccable ethics and unquestionable integrity in all that you do.
  • High energy, collaborative spirit and an entrepreneurial mindset.
  • Able to succeed in a small but rapidly growing organization.

Qualifications:

  • Education and experience: Strong strategic, leadership competencies are essential.
  • Have PhD., MD or other doctorate-level scientific degree.
  • Preferably clinical experience with includes responsibility for patient management.
  • Have 10+ years of leadership experience working in the pharmaceutical industry.
  • Exposure to both field and HQ based roles preferred.
  • Scientific or clinical experience in Renal disease preferred.
  • Successfully supported the launch of multiple drugs. Ideally, orphan drug experience.
  • Track record of developing strategy and executing operational plans.
  • Position will require 30% travel, including overnight stays.

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Reporting to the Senior Director, Clinical Operations, the Sr.CTM/CTM assumes a leadership role in cross-functional study management teams and will be responsible for the management and oversight of assigned clinical trials. The Sr.CTM/CTM is accountable for ensuring quality operational deliverables within budget and company timelines, in accordance with quality and regulatory guidance, ICH/GCP and company SOPs. The position will work closely with internal and external cross-functional representatives including Clinical Science, DMPK, Data Management, Biostatistics, Pharmacovigilence, Regulatory/QA and Finance to ensure successful completion of all clinical activities/project deliverables within budget and corporate timelines. The position will also provide oversight of the CRO and other third-party vendors on the assigned study.

Key Responsibilities:

  • Responsible for study planning/start up and management activities including CRO and other vendor selection, study feasibility assessment, development of study plans
  • Management of CROs and other third party vendors, including setting expectations, training, tracking timelines and deliverables, and issue management.
  • Contribute to development of critical clinical documents including study Protocols, ICFs, and Coordinate developments of study management plans, study manuals and other study-related documents.
  • Manage the CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
  • Oversee monitoring activities by the CROs are adequate and appropriate by reviewing visit reports, protocol deviations and CAPAs; Co-monitor sites to provide sponsor oversight.
  • Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
  • Coordinate/plan investigator meetings and/or site and CRA training.
  • Perform financial management, including review and approval of site and vendor invoices.
  • Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
  • Perform review and QC central clinical files and trial master files.
  • Collaborating with study management team identify potential risks so enrollment, patient safety and credible data, recommend risk mitigating strategies and implement corrective and preventive actions as needed.
  • Serve as a liaison and resource for investigational sites; review investigator contracts and site payments.
  • Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
  • Organize and manage internal team meetings and other trial-specific meetings.
  • Participate in the development, review and implementation of departmental SOPs and processes.

Experience:

  • Minimum 5-7 years of clinical trial management experience (CTM-4 & Sr. CTM – 6) including in house CTM experience in a small to mid-sized biotech/pharmaceutical company working on cross functional study teams in contributory or lead capacity with prior study monitoring experience, being knowledgeable in study site logistics
  • Working knowledge in all phases of study management from start-up through study close out, including protocol development, ICF creation, site feasibility/start up, contract/budget negotiation and tracking budget scope, safety reporting, data cleaning and generating CSR
  • Experienced in CRO/vendor management with demonstrated skills in negotiation and in developing effective relationships with outside vendors and CROs
  • Needs to have good understanding and demonstrated knowledge of basic data management, including working with EDC, biostatistics and pharmacovigilence activities
  • Outstanding written and verbal communication skills in professionally communicating and guiding individuals and teams in all efforts related to Clinical Operations deliverables is required
  • In depth knowledge and ability to interpret and implement FDA regulations, ICH GCP guidelines and other regulations is required
  • Previous experience working in global studies is required
  • Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook (MS Office)
  • Experience in managing oncology clinical trials and/or orphan disease indications preferred.
  • Excellent organizational skills and ability to prioritize, multi-task and work in a fast paced environment to meet established timelines.
  • Ability to travel globally up to 15-20 % as needed to attend meeting and monitor, as required

Education:

  • Baccalaureate or Master’s degree or equivalent in a scientific or health care field is required.

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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

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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.

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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

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Formulation

ChemoCentryx is offering a unique opportunity for a highly motivated researcher to join our team, which is focused on the discovery and development of orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer. The ideal candidate will have significant experience in small molecule formulation development and preparation.

The primary role of this position is to provide pharmaceutics support for the development and preparation of formulations for new chemical entities from pre-clinical to IND and to advanced clinical development in Phase 2 and 3.

Responsibilities:

  • Design and conduct pre-formulation assessment studies of various novel drug candidates
  • Responsible for the development and evaluation of oral dosage forms primarily in support of pre-clinical studies
  • The successful candidate will be responsible for preparation and timely delivery of formulations in support of efficacy, pharmacokinetic and toxicology studies
  • Responsibilities include managing and supporting multiple in-house stability studies
  • The successful candidate will be responsible for evaluation and developing prototypes of different oral dosage forms in support of clinical studies (such as powder-in-bottle, liquid suspension, modified release technologies and solubility-enhancing platform)
  • The successful candidate is expected to have strong hands-on experience on spray drying technology, in vitro dissolution and disintegration testing
  • The candidate will have opportunity to support drug product technology transfer from in-house “proof-of-concept” prototypes to CRO clinical manufacturing sites, serve as the technical representative during manufacturing operations and participate in technical troubleshooting, review manufacturing batch records and CMO summary reports
  • Responsible for maintaining accurate laboratory data records and expected to summarize data regularly
  • Share responsibility for management and development of the Pharmaceutics/Formulation laboratory; maintaining good operating condition of equipment and observing safety laboratory guidelines
  • The successful candidate must be self-motivated and organized, enjoy scientific investigation and thinking, proactively identify issues, and develop solutions

Qualifications:

  • BA/BS degree in a related scientific discipline with 5+ years of industry experience
  • Direct hands-on experience with HPLC, XRPD, DSC, TGA, light microscopy, particle-size distribution, density, and pH meter
  • Experience on diverse oral drug product manufacturing unit operations: granulation, spray drying, encapsulation, tableting and film-coating
  • Solid knowledge on dissolution and disintegration testing for solid dosage form
  • Effective communication skills are important to interact with scientists in a highly interdisciplinary and collaborative research environment
  • Independent worker who is willing to take on new responsibility and to learn new skills
  • Good team player who is willing to listen and understand different specific formulation needs of discovery team members

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

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