Director of Clinical Development

Organization
Ariosa Diagnostics
Job Location
5945 Optical Court
San Jose, CA 95138
Salary
DOE
Benefits

Full health care benefits (Medical, Dental, Vision), 401k, Employee Assistance Program, PTO, Life Insurance-including Supplemental, discounted gym membership, and Commuter Benefits Program.

Job Description

Director of Clinical Development

The Director of Clinical Development is a full-time position, to which you would devote substantially all of your professional effort, reporting to the Chief Medical Officer.  You would be primarily responsible for all clinical development and clinical affairs operations activities with responsibility for developing and implementing the overall clinical research strategy through functional interaction with Research and Development team and other senior management. Principal responsibilities include:

  • Management and oversight of all clinical study activities,
  • Recruit and manage clinical research associate, program manager(s) and database manager team members and other relevant staff as it relates to clinical operations,
  • Mentors and develops Clinical Affairs staff. Directs internal staffing and performance management, including hiring, training, coaching and performance reviews.
  • Participate in regulatory strategy and matters especially as they pertain to clinical development activities, in close collaboration with Regulatory Affairs
  • Oversee clinical site management especially in regards to recruitment, monitoring, compliance and maintaining excellent partnerships with site PIs and staff to maximize subject enrollment,
  • Establishes and approves (with outside vendor, Executive team, biostatistics group) scientific methods for design and implementation of clinical protocols, data collection systems and final reports
  • Oversee data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, white papers and assist with manuscript preparation,
  • Creates and directs program/project-related advisory committees as needed, DSMB and/or expert consultants
  • Forecasting of clinical activities and assist in developing clinical operational budget, 
  • Assist in developing clinical strategy for Company to advance product development, launch, and adoption,
  • Establish and maintain excellent partnerships with contractors, vendors, CROs, and internal team members,
  • Guide development of in-house operations SOPs, guidelines and systems,
  • Travel to clinical sites when needed for site recruitment and review and meetings both domestic and international,
  • Keep company officers well informed of progress, problems and opportunities; provides weekly enrollment and program updates to senior management.
  • Ensures that Clinical Affairs department effectively interfaces with key functional groups.
  • Other matters as may be determined by yourself and the Company.
Requirements
  • Prior industry experience (minimum 5 years) with knowledge of GCP, clinical trial conduct, and data interpretation. Prior experience in diagnostic development and/or women’s health desired.Requirements: 
  • Strong organizational and communication skills are required as well as extensive knowledge of Clinical Research, including FDA and international regulations, GCPs, clinical study design and documentation, and conduct of clinical trials
  • Experience with both CBER- and CDRH-regulated clinical trials
  • Program management skills enabling efficient planning and execution of program milestones within budget and in time
  • Experience managing/overseeing large projects with both CRO and internal staff and proven record of successful management of several projects in different business areas at the same time
  • Demonstrated management, leadership skills and interpersonal skills through successful development and management of clinical study and project management group
  • Ability to interface with other functions in the Clinical Development group as well as other functions in the company.
  • Excellent verbal and written communication skills.
  • Ability to work collaboratively in a dynamic and fast paced environment.
  • Proficiency with computer software such as Word, Excel and PowerPoint is required.
How to Apply

Please apply directly to our Careers Website using the following Application Form:  http://ch.tbe.taleo.net/CH17/ats/careers/requisition.jsp?org=ARIADX&cws=1&rid=33

About Our Organization

Ariosa Diagnostics, Inc. is a molecular diagnostics company committed to providing safe, highly accurate and affordable prenatal tests for maternal and fetal health. Led by an experienced team, Ariosa is using its proprietary technology to perform a directed analysis of cell-free DNA in blood. Ariosa's simple blood test equips pregnant women and their healthcare providers with reliable information to make decisions regarding their health, without creating unnecessary stress or anxiety.

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