Careers

Clovis Oncology is looking for dedicated people who are interested in joining
a growing organization.

 

IT Support Analyst

Reports to: Manager, IT Operations
Department: Information Technology
Exempt/Non-exempt: Non-exempt
Job Location: San Francisco

Role

The IT Support Analyst will provide all levels of technical support and training to end users. A mix of interpersonal and technical skills will be required to support both local and remote staff. Maintaining a high level of customer satisfaction is the primary objective of this position. After-hours work will be required periodically to support scheduled maintenance, projects, and unscheduled emergencies. Typical activities may include but will not be limited to the following:

  • Provide both remote and desk-side support to employees across multiple locations. Supported products and technologies include, but are not limited to:
  • Microsoft Online Services BPOS/Office 365 administration
  • SharePoint 2007
  • Windows 7
  • Microsoft Office 2007/2010
  • Dell notebooks and desktops
  • Active directory computer and user accounts
  • Blackberry
  • iPhone and iPad
  • LAN and internet connectivity troubleshooting
  • Remote connectivity and troubleshooting
  • Network printers & faxes
  • Video conferencing
  • Cisco VOIP phone setup and support
  • Disk imaging tools
  • Client management tools
  • Collaborate with IT team members and provide support on IT projects.
  • Prepare and deploy PCs and Smartphones.
  • Track assets as they are received, deployed and redeployed.
  • Document support requests and solutions in helpdesk system.
  • Document support processes and procedures.
  • Conduct both new hire and ongoing computer system training and education.
  • Comply with IT Policies and SOPs.

Requirements

A Bachelors Degree or equivalent is preferred; current industry certification is a plus. Candidates must have 4+ years of experience providing tier 1 through 3 remote and desk-side technical support across a wide variety of client technologies. Successful candidates will have experience providing IT support in a fast-paced SMB corporate environment. Windows 7 support experience is highly preferred as well as experience working in a regulated industry. Candidates must be able to lift 50 pounds.

Personal Qualities

The successful candidate will be able to provide user support in a way that shows patience, effectiveness and enjoyment. Rapid responses to end user requests and a belief in continuous follow-up and communication are essential. Candidates must be comfortable working with staff at all levels of an organization, both remotely and in person. An unusually broad range of experience will inform the candidate's troubleshooting skills with confidence and pride. The candidate must be able to prioritize a diverse range of tasks while providing effective support.

 

Director, Pharmacovigilance Operations

Reports to: VP Clinical Development and Safety
Department: Safety
Exempt/Non-exempt: Exempt
Job Location: Boulder or San Francisco

Role

The Director, Pharmacovigilance operations (DPO) will work closely with the VP Clinical Development and Safety to ensure Clovis Oncology has safety systems in place that protect patients and comply with reporting regulations in the territories where it is active (including EU, Russia, Americas and Japan). Typical activities may include but will not necessarily be limited to:

  • Develop strategy for use of vendors and best allocation of internal resource that maintains a robust and compliant safety reporting system
  • Monitor operational performance and produce relevant performance metrics; lead the development of remediation strategy and activities as appropriate
  • With clinical operations and biometrics, identify and select suppliers of pharmacovigilance services
  • With clinical operations, coordinate processing and review of case materials from vendors
  • Input into safety management plans for individual clinical studies
  • Serving as a member/providing ad hoc advice (as appropriate) to clinical sub-teams
  • Training of Clovis colleagues, CRO and study site staff on Clovis safety reporting procedures
  • Keep up to date with pharmacovigilance regulations in major territories through educational activities and maintaining a network of appropriate contacts
  • With statistics/data management, select an appropriate safety database to bring in house (in the future, if appropriate)
  • As the Clovis projects mature (post 2012) build an internal safety operations group with global capabilities

Requirements

A bachelor's degree and strong knowledge of pharmacovigilance processes and regulations (including Eudralex volume 9A and FDA 21 CFR §312 and 314) gained through previous clinical development experience are required. Previous participation in a clinical development program is essential as is experience of working in a small company with the majority of pharmacovigilance services outsourced. Fluency in English is required.

Personal Qualities

The successful candidate will be a confident person keen to take responsibility for assigned activities. Although plenty of support will be available from the line manager, the DPO will be expected to function largely independently, and would thrive in a mentored rather than a directed environment. The DPO will be able to take on new and varied activities and will enjoy participating at every level of the project, ranging from detailed review of documents/data through to strategic planning of pharmacovigilance activities. The DPO will be committed to working within a project team structure, will be an excellent negotiator and will be able to manage other functions through a matrix. The DPO will be able to embrace the challenges and opportunities offered in a small company environment and to capitalize on the experience to develop skills and attain career goals.

 

Senior/Principal Research Scientist, Translational Medicine

Reports to: Senior Director, Translational Medicine & Molecular Diagnostics
Department: Translational Medicine
Exempt/Non-exempt: Exempt
Job Location: San Francisco

Role

Reporting to the Senior Director of Translational Medicine & Molecular Diagnostics, the Senior/Principal Research Scientist will be initially responsible for leading the pre-clinical biology elements of the rucaparib program within the Translational Medicine (TM) function. The scientist will be required to perform/lead pharmacology, cellular, and molecular experiments to characterize drug activity and mechanisms of sensitivity/resistance in a variety of tumor indications.

The key tasks for the Scientist initially will include the following:

  • Implementation of an integrated Translational Medicine strategy for rucaparib across tumor indications
  • Implementation of in vitro models (biochemical and cellular assays) in various tumor types to support the clinical development of rucaparib
  • Management of academic/commercial collaborations supporting the translational aspects of rucaparib
  • Development of assays to interrogate optimal combination therapy strategies
  • Effective collaboration with cross functional team members (clinical, TM operations, diagnostics) to meet the project objectives
  • Representation of the TM function at the Project Team level
  • Recruitment and supervision of research technicians

Requirements

A PhD in molecular biology or related field, with at least five years of research experience in cancer biology is required. Possessing an enthusiasm for personalized medicine, he or she will have demonstrated success in the field of cancer biology with a focus on drug development. The ideal candidate will have hands-on experience in molecular and cellular biology with working knowledge of pre-clinical cancer drug development, including:

  • Demonstrated experience (peer reviewed publications) in cancer drug development is required.
  • Experience with designing, executing, and analyzing data from molecular and cell-based experiments is required.
  • Experience with defining mechanisms of drug sensitivity and resistance is required.
  • In vitro pharmacology experience is strongly preferred.
  • Experience with FACS analysis is preferred.
  • Experience in PARP inhibitors is strongly preferred.
  • Strong organizational skills, ability to prioritize and multi-task.
  • Excellent verbal and written communication skills.

Personal Qualities

The Scientist will be a dynamic and innovative cancer drug development biologist with a well-developed sense of teamwork. He or she will have the interpersonal skills required to communicate effectively with collaborators and compound development teams.

 

Clinical Research Associate

Reports to: Sr. Manager, Clinical Operations
Department: Clinical Operations
Exempt/Non-exempt: Exempt
Job Location: San Francisco, CA

Role

  • Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
  • Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, etc) and proactively identify solutions within the clinical team when issues arise.
  • Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials.
  • Assist with evaluating, selecting, and managing clinical study sites.
  • Assist in the evaluation and management of CROs and other vendors. Negotiate and manage contracts/budgets with CROs and other vendors.
  • Provide input to and manage project objectives to meet timelines and deliverables.
  • Provide routine study updates to the project team/sub-team.
  • Analyze and develop action plans to address issues with investigational sites and/or CROs.
  • Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
  • Assist in training new team members (CRA, CTA) on study processes, as required.
  • Responsible for tracking/maintaining study metrics/progress and updating Team.
  • Serve as a primary contact for sites.
  • Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues.
  • Review and negotiate clinical site study contracts and budgets.
  • Plan, coordinate and present at Investigator Meetings and CRA Training meetings as requested.
  • Perform site qualification, initiation, interim monitoring and close-out visits as needed. Perform co-monitoring visits.
  • Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings.

Requirements

  • Bachelor’s degree in a scientific discipline or health-related field.
  • Minimum of 4 years experience as a CRA in a biopharmaceutical company or CRO.
  • Previous experience with oncology clinical trials preferred.
  • Experience with working on Global Trials a strong plus.
  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
  • Demonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-out.
  • Strong organizational skills, ability to prioritize and multi-task.
  • Excellent verbal and written communication skills.
  • Demonstrated problem-solving and negotiation abilities.
  • Ability to work as part of a team/active team participant.
  • Capacity to manage up and also roll-up sleeves when necessary.
  • Willingness to travel as necessary, consistent with project needs.
  • Computer proficiency (MS Word, Excel, Powerpoint)

To apply for one of the posted positions, please send a resume and cover letter to: careers@clovisoncology.com. Please include the job to which you are applying in the subject line of your e-mail.