Director of Clinical Operations, Sequencing

Organization
Roche Sequencing
Job Location
5945 Optical Court
San Jose, CA 95138
Job Description

• Main point of contact in Clinical Operations for the NIPT/Women’s Health Life Cycle Team

• Works closely with the Clinical Science Lead and Medical Affairs Lead as part of the Core Clinical Research Team

• Accountable for the planning and execution of all phases of clinical studies

• Works closely with Clinical Operations project teams to support the planning, implementation and execution of clinical trials

• Plans, implements and executes clinical trials to support regulatory submissions for clinical claims as well as claim expansion of products for RSS; other trials include those required to generate preliminary data leading to design of effective trials for product registration

• Plans, implements and executes additional post-launch clinical trials of CE-marked and/or FDA approved/cleared products

• Works independently and is highly autonomous

• Represents the department at cross-functional project teams, and business unit/area and divisional levels

• Serves as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects

• Fully accountable for the results and achievements of the area

• Delivers on action items with high quality and on time

• Regularly interacts with executive management on work of area(s) that impacts larger organizational goals

• Frequent interaction with internal and external CLIA/CAP labs

• Implements global study support strategies and initiatives

• Oversees sample requirements for studies and works closely with Bio-specimen Management (BSM) team to acquire specimens for use in clinical studies

• Supports the preparation of reports and summary documents (for internal and/or external customers/partners) for product registration

• Supports Clinical Science Lead by developing and managing overall study budgets along with budget and contract negotiations with study sites, central laboratories and CROs

• Prepares and tracks resource demand (both internal and external/outsourced) and study timelines with shared accountability with Clinical Science Lead

• Ensures adherence to regulations, guidelines and departmental standard operating procedures on the part of direct reports and project team

• Monitors the performance of outsourcing services through KPIs, as applicable.

• Maintains a high level of professional expertise through familiarity with scientific literature, Roche product portfolio and competitive environment

• Represents RMS in hospitals and labs, and interacts with Key Opinion Leaders, Investigators and other key customers in the field of Sequencing/NIPT/Women’s Health

• Provides technical input to study designs and clinical development plans

• Supports the preparation of clinical study proposals, protocols, reports and manuscripts

• Works with Data Management and Biometrics statistics staff on the design of documents and processes for the collection of study data from participating sites

• Supervises, mentors and trains Clinical Operations personnel at all levels, including: Sr. Manager, Managers, Clinical Research Monitors, CRAs, Sr. CRAs and/or Principal CRAs

• Ensures compliance of direct reports with Good Clinical Practices, worldwide regulatory requirements, SOPs and study protocols

• Collects and maintains Legal and Regulatory documentation, as applicable

• Ensures accurate and complete study management/data collection and transfer into the data management system

• Ensures site compliance with regulations and study protocol

• Acquires and maintains technical knowledge of product line

• Aligns processes and resources with other business areas (Roche Molecular Solutions, Roche Tissue Solutions, Roche Sequencing Solutions, Roche Professional Diagnostics and Roche Pharma) where applicable. 

Requirements

• Previous clinical trial and/or pharmaceutical environment experience in Women’s Health preferred

• Bachelor's or Masters in Biology, Chemistry, Molecular Biology or related discipline

• Previous IVD experience is required

• Previous BIMO Inspection experience is required

• Previous first-hand experience with responding to FDA Inspectors during Inspection

• 10+ years of experience in clinical trials with a significant management role.

• Extremely detail oriented

• Ability to work in a team situation

• Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to effective and efficiently handle problems

• Must meet timelines and manage sites

• Previous accountability for development and management of study budgets

• Excellent written and verbal communication/presentation skills are required

• MSWord, Excel, Project and PowerPoint skills are required

• Up to 35% travel may be needed (domestic and international)

About Our Organization

As pioneers in sequencing with a rich heritage in diagnostics, Roche's Sequencing Unit is committed to a future that fosters innovation to provide solutions that enable scientific discovery and deliver clinical value – We are Changing Science and Changing Lives.

At Roche, 91,700 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. 

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