Careers

Job Postings2018-12-13T20:10:26+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

Responsibilities:

  • For the COO and CEO: managing an extremely active calendar of appointments; completing expense reports; preparing correspondence; arranging complex and detailed travel plans, itineraries, and agendas; and compiling documents for travel-related meetings
  • Keeps CEO/COO well informed of upcoming commitments
  • 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
  • Assists board members with travel arrangements, lodging, and meal planning as needed
  • Assists in coordinating the agenda of senior management team meetings and off-sites, and all staff meetings
  • Edits and completes first drafts for written communications to internal/external stake holders
  • Follows up on contacts made by the CEO/COO and supports the cultivation of ongoing relationships

Qualifications:

  • Strong organizational skills that reflect ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast paced environment
  • 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
  • Proficient in Microsoft Office (Outlook, Word, Excel)

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Clinical

Responsibilities:

  • 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
  • Collaborates with Clinical, Finance and Research and Development in the preparation of budgets
  • Documents and maintains project team outcomes, activities and decisions
  • Facilitates project team meetings, cross-functional information sharing and ensures alignment
  • Manages and can operationalize a set of alliance partnerships
  • Understands key interdependencies, drive decision-making, issue resolution and execution across collaborations, as well as keeping all stakeholders informed and on collaboration details

Qualifications:

  • BS or BA in Life Sciences. MS,MBA or Ph.D.is preferred; however experience and accomplishment will be considered in lieu of advanced degree
  • 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
  • 5 years-experience in project management in support of drug development
  • PMP certification preferred
  • Expertise and accomplishment in drug development methodology
  • Has financial acumen; can plan and manage budgets; metrics
  • Project management software to manage budgets, timelines and outcomes

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Summary/Objective
Residing in the Clinical Development Department the Senior Director of Biostatistics is a strong leader and will serve as Head of Biometrics in the organization. The (Senior) Director will develop and lead the statistical strategy for all clinical programs of the organization. Apart from the ability to conduct biostatistical analyses her-/himself the biostatistician will also be able to complete these analyses through other personnel within the organization or through vendors/CROs. Data management will reside under the Biometrics leader through oversight of either internal data managers or external vendors. The (Senior) Director of Biostatistics has outstanding business presence and communication skills to effectively represent Biostatistics to internal and external stakeholders. The individual will effectively represent biostatistics in interactions with regulatory agencies. The successful candidate requires thorough experience with statistical data analyses of clinical pharmaceutical trials in all development phases as well as deep knowledge of the regulatory requirements for successful drug approval. Previous experience with successful regulatory submissions such as an NDA is strongly preferred.

Essential Functions
Essential functions and responsibilities include the following:

  • Oversees statistical strategy and provides statistical support for all clinical programs. Collaborates with clinical and regulatory leads in defining general strategic approach, creating clinical development and statistical plans (CDP and SAP), and producing individual protocols.
  • Works independently, or with other statistical departmental members or Biometrics personnel at CROs, to develop effective statistical approaches applicable to project
  • Contributes to the design of clinical trials, including statistical sections of the study protocol, randomization methodology, etc.
  • Oversees execution of or conducts statistical analyses, prepares statistical methods and results sections for clinical study reports (CSR), and production of overall summaries such as NDA documents S.
  • Generates, reviews and approves key results and statistical conclusions. Provides guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
  • Plans and tracks project activities, timelines, and resource use across projects. Maintains awareness of industry standards, regulatory requirements, and departmental guidelines and SOP
  • Provides project support through the specification/review of tables, figures and listings shells, and the writing/review of CDISC (SDTM and ADaM) datasets
  • Works with the SAS Programming team to coordinate the reporting of the results of clinical trial.
  • Participates in the quality control review of the output form the CRO or internal team.
  • Makes statistical contributions to manuscripts for publication / presentation
  • Develops and directs Data Management activities by own experience and by overseeing internal or external data management personnel.
  • Builds, leads and directs a fully integrated team of Biometrics and Data Management personnel within the organization or external contractors or CRO personnel.

Competencies

  • Customer/Client Focus.
  • Collaboration Skills.
  • Communication and Writing Proficiency.
  • Leadership
  • Problem Solving/Analysis.
  • Thoroughness.
  • Time Management.

Supervisory Responsibility
This position has direct supervisory responsibilities for internal personnel and/or external vendors.

Travel
This position requires approximately 10-15% travel.

Required Education and Experience

  • MS or Ph.D. in Biostatistics, Statistics, or closely related field.
  • 10+ years of experience in design and analysis of clinical trials
  • Thorough experience with statistical data analysis of clinical pharmaceutical trials (Phase 1-3) as well as integrated data analyses of safety and efficacy. Previous experience on regulatory submissions such as NDA strongly preferred
  • Ability to develop and lead statistical strategy for all clinical programs in the company
  • Has effectively overseen and collaborated with a fully integrated team comprised of biostatistics, programming, data analysis, and data management. Needs to have the ability to build and lead a fully integrated team of Biometrics and Data Management
  • Solid experience in providing leadership, oversight & management of biostatistical, programming, and data management services provided by CROs
  • Broad knowledge as well as deep understanding of advanced statistical concepts and techniques, pharmaceutical clinical development and lifecycle management
  • Solid knowledge of statistical regulatory guidance and standards (e.g., FDA, ICH and EMA)
  • Excellent technical skills in Biostatistics including strong knowledge of the CDISC SDTM and ADaM models, Proficiency in SAS, R and other relevant statistical analysis software systems.
  • Experience in the following therapeutic disease areas is preferred but not a must: Inflammatory diseases, Rheumatology, Nephrology
  • Outstanding business presence to effectively represent Biostatistics in interaction internally and externally, e.g. with senior management of the organization, cross-functional committees, Key Opinion Leaders, etc.
  • Solid experience in representing biostatistics in face-to-face meetings with regulatory authorities
  • Excellent written and verbal communication. Ability to communicate complex statistical matters effectively to all program team members as well as to Senior Management.
  • Excellent analytical, problem solving and organization skills.
  • Ability to influence others, at all levels of the organization, even without direct hierarchical authority, and affect change across organizational boundaries.
  • Ability to collaborate effectively with peers, within global teams and in communicating with senior leadership.
  • Must be a strong leader that creates vision for the group and who is able to inspire and motivate team members. Takes stand on important issues in a productive, respectful way.

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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

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Human Resources

Principal duties and responsibilities:

  • Direct and manage employee recruitment process.
  • Design, communicate and implement industry competitive and cost effective compensation, employee benefit and retention programs. In anticipation of the initial launch of its lead drug candidate, develop and recommend a comprehensive compensation plan appropriate to support a commercial organization.
  • Provide leadership, consultation, and advice to the management staff in areas involving organizational effectiveness, performance management, leadership and management development and employee communications in support of the Company’s corporate goals.
  • Manage employee relations issues (conflict management, problem solving, organizational interventions, policy development and interpretation) leveraging other HR legal and senior line management resources as appropriate.
  • Lead company compliance with all existing governmental regulations and reporting requirements.
  • Oversee and manage administrative support staff, including reception

Qualifications:

  • Minimum of a Bachelor’s degree or equivalent in Human Resources, Business, Organization Development.
  • Ten plus years of progressive leadership experience in Human Resources positions in the biotechnology or biopharmaceutical industry. Previous experience at the director level required. Public company experience preferred.
  • Specialized training and experience with employment law, compensation, organizational planning, organization development, employee relations, safety, training, and preventive labor relations, preferred.
  • Excellent written and oral communication skills, including ability to communicate effectively with external parties and all levels of staff.
  • Strong computer skills in MS Office Suite, HRIS, Recruiting systems. Must include Excel and skills in database management and record keeping.
  • Demonstrated experience in the practice of a high level of confidentiality.
  • Strong knowledge of competitive compensation and equity incentive programs.

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

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