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.

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

Clinical

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
Reporting to the Chief Medical Officer, the Senior Clinical Trial Manager will be responsible for the day-to-day management of ChemoCentryx clinical trials, including management of contract CROs conducting company sponsored clinical trials.

Specific Responsibilities

  • Work with 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.
  • Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Oversee monitoring activities at clinical CROsby reviewing visit reports, protocol deviations and CAPAs; attend co-monitoring visits as required.
  • Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
  • Review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals,Informed Consent Forms, and other study-related documents.
  • 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 file.
  • Identify potential study issues and recommend and implement solutions or corrective 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.
  • Participating in the development, review and implementation of departmental SOPs and processes.

Qualifications

  • Baccalaureate or Masters degree or equivalent in a scientific or health care field is required.
  • Minimum of 3-5 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance.
  • Experience in managing oncology clinical trials and/or orphan disease indications preferred.
  • Someone with biotech or pharmaceutical experience as an in-house CTM.
  • Someone with CRA experience who has moved into a CTM position.
  • Clinical operations experience at a small or mid-size company.
  • Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
  • In-depth knowledge of clinical research operations, including interpretation and Implementation of FDA regulations/ICH guidelines, GCP and other applicable regulatory guidelines required.
  • Knowledge of Electronic Data Capture {EDC}.
  • Excellent verbal and written communication skills in order to effectively communicate with site staff, vendors and internal cross functional team members.
  • Strong computer skills including knowledge of Microsoft Excet Word, and Outlook.
  • Ability to work within established timelines, in a fast paced environment.
  • Excellent organizational and priority management skills.
  • Ability to prioritize and handle multiple tasks at once
  • Travel up to 15-20% may be required.
    • Experience in the U.S. and other countries.
    • Some experience with Pharmacovigilance would be good.

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

Submit Resume
Working with CCXI Senior Management, Contract Development Organizations and selected Consultants, this individual is responsible for the development and overseeing the execution of all the technical activities associated with product development in support of Clinical Development and Commercialization. In particular those activities associated with analytical methods development in support of active pharmaceutical ingredient and drug product development.  The individual should be knowledgeable in drug product manufacturing process for oral solid dosage forms. In addition, this individual will be responsible for overseeing all the CMC activities supporting CCXI programs including the development timelines and deliverables according the Department goals.

Specific Responsibilities

  • The Pharmaceutical Development Senior Manager/Associate Director is responsible for providing project management and technical expertise to the CMC activities for ChemoCentryx programs.
  • Responsible for providing technical expertise to all the activities associated with the formulation and process development
  • Responsible for providing technical expertise with all the analytical development activities in support of API and DP development
  • Responsible for overseeing the manufacture of clinical trial materials at the selected CMO
  • Working closely with the QA organizations provide solid input in the resolution of issues associated with the manufacture and release fo CTM
  • Working closely with QA responsible for the development and maintenance of an accurate inventory of the Clinical Supplies
  • The scope of the responsibility is from IND, Phase 1, 2, 3 to Commercialization and post approval life cycle management.
  • The Senior Manager/Associate Director participates in all projects and will manage multiple program collaborating with the CCXI following groups: Process Chemistry, Biology, DMPK, Pre-
  • Clinical, Outsourcing, Clinical Operations, Quality, Finance and Regulatory Affairs.
  • The Senior Manager/Associate Director will have support project management to the Outsourced Key Accounts Teams.
  • 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 Senior Manager/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, expands 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 and drug product manufacturing).
  • Assists in the preparation and review of regulatory submissions for USA and worldwide heath agencies.

Requirements

  • BS, MS or PhD of a scientific degree with 5 to 15 years of technical and direct product development experience in the areas of Drug Product Formulation/Manufacturing Process/Analytical Development
  • Proven experience in the development of analytical methods and their qualification/validation in support to API and products in the late phases of development.
  • Deep knowledge of the GMP regulations requirements in product development manufacturing and release of clinical and commercial products
  • Knowledge of pharmaceutical packaging and labeling and current or impending regulations is desired but not essential
  • Proven track record in strategic planning for late stage development programs. Commercial experience desired.
  • Must have strong regulatory compliance knowledge including FDA, cGXP, etc.
  • Provide technical support during external audits of vendors and subcontractors
  • 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%

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

Submit Resume

Finance

Responsible for all financial planning and analysis, reporting and compliance functions, including but not limited to, internal financial and SEC regulatory reporting.

Principal Duties and Responsibilities

  • Responsible for recording collaboration and grant revenue, including research and development funding from our collaboration partner.
  • Responsible for accrual for preclinical and drug manufacturing expenses.
  • Ensure timely analysis and account reconciliation, including preparation of monthly journal entries to the general ledger.
  • Responsible for all external financial reporting, including quarterly and annual regulatory filings and other required filings with the Securities and Exchange Commission.
  • Responsible for concurrent filing of XBRL exhibits with quarterly reports (Form 10-Q) and annual reports (Form 10-K).
  • Sustain Company’s Sarbanes-Oxley Section 404 compliance efforts with respect to SEC Reporting, related monthly close and other activities.
  • Perform special projects and other analytical support as requested.

Job Scope

Works with all employees to assist in financial accounting matters.

Interaction (level of positions, nature of interaction, frequency):

Internal Contacts:

Regularly interacts with company leaders and other employees regarding finance and accounting related matters.

External Contacts:

Regularly interacts with external auditors (government and corporate) and vendors.

Amount of Supervision Received: Requires minimal-to-moderate level of supervision. Minimum supervision on routine matters, moderate supervision on more complex matters.

Specifications

Education: BA/BS in Accounting/Finance.

Experience: 4-6 years related financial accounting experience. CPA with “big four” experience and/or public biotechnology or biopharmaceutical company experience required.

Skills and Capabilities: (Specific abilities needed for the position)

  • Energetic, flexible team player and hands-on leader with the ability to manage in a dynamic environment. Diplomatic yet effective in garnering respect and cooperation from management of other function areas.
  • Strong attention to details and accuracy.
  • Strong problem solving skills.
  • Excellent written and oral communication skills, including ability to communicate effectively with external parties and all levels of staff in a timely fashion.
  • Time management and organizational skills. Ability to multi-task and effectively prioritize.
  • Proficiency with MS Excel, Word, PowerPoint and Great Plains
Submit Resume