The DMPK group is dedicated to enabling the discovery, developmentand commercialization of safe and effective medicines by elucidating theabsorption, distribution, metabolism, excretion and pharmacokinetic propertiesof small molecule drug candidates. We accomplish this through the applicationof state of the art technologies and sciences of bioanalysis, drug metabolism,drug transport and pharmacokinetics. The DMPK group works in close partnershipwith disciplines such as medicinal chemistry, pharmacology, toxicology,pharmaceutical sciences, clinical pharmacology and regulatory to optimizeleads, select clinical candidates, conduct preclinical development studies,support clinical evaluation and contribute to IND and NDA filings.

We are seeking a candidate to support both in vitro and in silicoADME.  The candidate will work with anestablished team on various in vitro assays and will collaborate with otherscientists in the group to perform hypothesis-driven studies to address ADMEquestions.  On the in silico side, thecandidate will apply ADME models to support projects and maximize the value of existingADME data. They will work at the intersection of modeling ideas, modelgeneration and experimental investigation to support/build SAR and meet projectneed.  A key part of the role will becontinuing education in the department on use of predictive DMPK and championinguse of in silico tools. The candidate will be a highly effective and energizingcollaborator and will work scientists from multiple disciplines including computationaland medicinal chemistry, safety assessment and pharmaceutical sciences.

The DAS is responsible for the specifications, acquisition, loading and delivery of non-CRF data including IxRS, laboratory, pK and other data.

Responsible for the production of non-CRF data collection specification documentation 

Defines the study specific non-CRF data handling strategy

Collaborates with SMT to agree on vendor expectations for the collection and transfer of data 

Reviews and refines the technical requirements with service provider to establish the transfer of non-CRF data  

Responsible for establishing appropriate transfer methodology with external data provider

Provides transfer methodology training and documentation on non-CRF data for external vendors.

Responsible for configuring the data loading tools based on data collection specifications

Receives, uploads, confirms and communicates status of test data transfers to validate and accept file format and database structure

Performs verification and resolves data transmission, file format and loading errors with data providers  

Proactively checks all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorised

Delivers data to external recipients and review bodies via established transfer methodologies

Represent CDM on IxRS sub teams and works with the Study Management Team to develop IxRS specifications and implement the system

Coordinates and plans subfunction activities to meet program-level deliverables and timelines

Develops and maintains the subfunction standards for the studies in a program

Collaborates with Data Modeling Specialists to define study data collection standards for new assessments and collaborates with them to implement new standards

Effectively communicates ideas, project goals and status of work and can present to senior management 

Proactively develops solutions to complex problems requiring the regular use of ingenuity and innovation

Sets targeted timeframes for  deliverables and anticipates potential scenarios that may result in timeline delays; able to influence and negotiate a positive outcome

Proactively develops contingency plans to reduce impact of risks that may occur, to analyze effectiveness of strategies and to monitor and review risks 

• Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
• Lead efforts to provide on-going technical support for production at internal and external contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement
• Lead and/or participate in global initiatives and cross-functional investigational and project teams
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
• Support product impact and root cause assessments for process discrepancies and Quality investigations
• Travel within the Roche network and to contract manufacturing sites will be required
  

The MCCO Solutions team in Genentech’s IT Americas organization is looking for a motivated Sr. Software Quality Analyst to lead all aspects of Quality Assurance and QA Testing of technology projects in support of US Commercial Operations.  The Sr. SQA will be responsible for managing the work of assigned Quality Assurance (QA) resources, effectively building and tracking QA Plans and Strategies, and ensuring end-to-end quality in all phases of the project lifecycle.  

Duties:

• Plan and execute functional, performance and stress testing on applications and systems using automation and manual testing
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (Mercury Suite, Selenium, Segue, etc)
• Lead the development of SQA Test Plans, Test Procedures, SQA lab standards and tool requirements
• Identify opportunities for process improvements that streamline development activities while minimizing risk
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage work of onsite and offshore SQA testers as required 

In the position of Senior Regulatory Product Manager in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the product’s lifecycle and business needs.  This role within Pharma Technical Regulatory is focused on the development of strategies supporting biologic marketed products.  The successful candidate must have demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork and communication.  He/She will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives. The successful candidate must have an ability to develop and drive innovative solutions to complex regulatory strategies while maintaining compliance with regulations.  With a focus on biologics marketed products, he/she will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.  Additionally, he/she will support departmental business processes to document and improve best practices and work efficiencies.

He/she will be responsible for leading a team that delivers timely compilation and of all necessary documentation for regulatory submissions to support technical content of regulatory submissions. He/she will ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.

The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Associate Scientist or Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Biologics.  This individual will be primarily responsible for the clinical pharmacology activities of Biologics in clinical development. This person will have responsibility for the Clinical Pharmacology strategy in order to ensure that appropriate dose/route/schedule decisions are made using the state of the art modeling and simulation strategies that are aligned with project needs. This will be accomplished by working in close partnership with Clinicians, Biostatisticians, Clinicians and project teams.  Responsibilities will include planning and reviewing study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings (worldwide) and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings (worldwide). Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams.

This position may be filled at the Sr. Business Systems Analyst or Principal Business Systems Analyst level.
 
The Sr./Principal Business Systems Analyst position is dedicated to business process analyses, design and optimization to enable the routine delivery of exceptional performance. This position sits within the MCCO Data Governance and Management (DG&M) department, which is charged with assisting the Strategic Pricing & Contract Management (SPCM) organization to achieve its goals and objectives.
 
This individual will be responsible for leading cross-functional process improvement projects, representing the department as the change agent, partnering with customers, leading internal efforts within the team, communicating and coordinating with key stakeholders, resolving conflicts within the team, and delivering real value-add sustainable cross-functional solutions. This individual will mentor project team members and staff in industry best practices, process improvement methodologies, and will be accountable for following/improving upon the methodology in alignment with Genentech values and behaviors.
 
This position will lead cross-functional project teams to:

•  Implement practical and sustainable business processes
•  Maintain department scorecards
•  Update and prioritize multiple project portfolios
•  Deliver project goals on budget and on schedule
•  Analyze business, process and systems performance, and identify improvement opportunities
•  Identify opportunities for team members to develop, evaluate and manage business case and cost/benefit analyses
•  Make recommendations to Senior Management based on business case and analyses
•  Lead decision making support and make recommendations regarding best options
•  Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution
•  Develop and use project plans to coordinate participants and track and report progress
•  Leverage industry research and analysis
•  Serve as advocate, mentor & role model for integrating best practices into the organization
•  Ensure improvement methodology and tools are utilized effectively to maximize benefits
•  Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

DUTIES & RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
• Stays abreast of therapeutic area product development and other related business strategies and plans 
• Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically complex projects
• Analyzes data, the regulatory environment and business objectives to recommend priorities
• Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
• Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
• Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
• Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
• Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
• Provides internal teams with direction on regulatory authority interactions
• Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources
• Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
• Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 
• Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and...

The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes.  Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.

Responsibilities:

The areas of major responsibility include, but are not limited to the following:

• Responsible for the day-to-day operations of the designated Medical teams.

o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules

o Co-leads and facilitates all medical team planning and decision-making

o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.

o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.

o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.

o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics 

o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements 

o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution

• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.

• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc. 

• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution 

• Conducts proactive risk assessment and change control for all assigned projects/programs

• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Clinical Data Management (CDM) is a department within the Biometrics function of the Product Development (PD) organization.   CDM provides data management expertise to study management teams in PD and in gRED (Genentech Research & Early Development).

RESPONSIBILITIES:

The Study Data Manager (SDM) is a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams.  The Study Data Manager leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.   The SDM interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met and provides technical coaching and mentoring on data management activities to colleagues.  The SDM also performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives;  responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals; responsible for the implementation of standards within Study Data Management across one or more CDM study teams; develops and executes ad hoc database queries utilizing data review and query tools;  manages projects resourced externally via contract research organizations or corporate partners; provides support to ensure that study conventions, processes, knowledge sharing and best practices exist across all studies within a program; participates in departmental discussion groups, formal working groups or special projects.  

As a Principal Staffing Consultant, you will play a lead role in managing the recruiting and hiring programs for our Product Development Staffing 

Main Deliverables:

1. Play a lead recruiting role for approximately 100 positions annually, with an average requisition load of 30-40.
2. Play a lead role in key Product Development  wide staffing initiatives, including those supporting our diversity and hiring best practices programs
3. Partner actively with HR Management to drive internal talent development and succession planning programs
4. Provide original thinking to staffing challenges and execute on ideas for improving patterns of work

Main Accountabilities:

• Deliver Recruiting Results
• Recruit with Insight and Strategy
• Innovate and Expand Possibilities
• Value Collaborations, Communication, and Teamwork
• Execute on Tactics, Tools, and Technology

Full Responsibilities:

• Managing expectations of hiring managers and candidates, identifying and resolving issues
• Drive the employment process and strategies within assigned organization, including developing complex recruiting strategies
• Demonstrate thorough understanding and adherence and enforcement of internal staffing process as well as contribute to the development of staffing process improvements
• Ensures recruiting solutions are consistent with Corporate Staffing goals and objectives
• Partner with Diversity and sourcing counterpart to develop and implement sourcing plans and strategies for your client groups while ensuring that the elements of diversity and organizational fit are included in the recruiting and hiring process
• Proactively manage escalation process related to all requisition activity (internal vs. external challenges)
• Perform executive recruiting, including identifying appropriate Contingency or Retained Search firms, maintaining relationships and partnering to ensure that candidates are interviewed expeditiously
• Develop advertising strategies for specific groups and coordinate advertising activities with recruitment advertising agency
• Build and maintain cross-functional relationships across HR and Staffing
• Utilize, update and maintain applicant tracking system and CRM
• May provide staffing reports and metrics
• Present information on results and metrics at different levels (i.e. to employees, peers and senior level HR and client groups)
• Act as point person for clients in providing staffing reports and metrics
• May Lead and or participate in HR related projects or enterprise wide initiatives.
• Partner with Client Group on internal talent management, including succession planning, talent review and internal candidate movement
• Coach managers in providing feedback to candidates, developing offers, determining competencies, coordinating and training interview team
• Partner with Diversity and HRDs to develop and implement a recruiting strategy that ensures our candidate pipelines are diverse
• Conduct interviews using in depth behavioral and skills assessment techniques
• Educate hiring managers on legal implications in hiring
• Adjust the strategy and align it with the changing needs of the business
• Ensure your compliance with EEOC/OFCCP regulations
• Act as project manager for client focused staffing projects (not just req focused)
• May partner with finance in determining headcount for client group, as well as manage the reconciliation of budgeted headcount vs. actual headcount
• Work with Staffing Manager on recommendations for the EC Group recruitment/relocation budget
• Oversee relocation/recruiting budget for individual client group at the officer level
• Manage multiple relationships, both internally and externally
• Attend professional conferences and networking events
• Responsibility for Conference/Event management related to external recruiting, partner with Corp Staffing in strategic direction of event, and determine ROI for event participation

Global Regulatory Leader

Accountable for regulatory management of a project(s) and leading a matrix team of regulatory professionals.

Primary Responsibilities and Accountabilities

• Accountable for global regulatory strategy and global regulatory deliverables for a PD project 
• Accountable for leading a matrix team of Regulatory Professionals, and for the RAFT deliverables.  Responsible for motivating and inspiring RAFT members
• Responsible for holding regular RAFT meetings, in accordance with RAFT guidance.
• Responsible for representing the regulatory function on cross-functional project teams (Lifecycle Teams).
• Responsible for representing the regulatory function on project specific matters to governance bodies
• Accountable for global regulatory Health Authority Interactions
• Accountable for managing decision-making, and conflict resolution surrounding regulatory issues within the Project Team and RAFT.  Responsible for ensuring appropriate escalation to functional management when necessary.
• Accountable for leading the RAFT on a PD project to:

• deliver strategic regulatory input to the lifecycle management of a project. 
• deliver specific guidance on regulatory issues such as legislation, guidelines, procedures to internal stakeholders (project team, regulatory function, governance bodies) 
• deliver integrated plans relating to regulatory submissions or specific functional projects 
• deliver regulatory submissions, in accordance with project timelines
• manage successful interactions with regulatory agencies and 
• analyse and landscape the regulatory environment for impact on the project and to brief internal stakeholders, as appropriate
• Responsible for sharing best practices within function to ensure efficiency and consistency across teams.
• Responsible for leading special regulatory projects/global process initiatives, as assigned.
• Responsible for acting as a change agent and role model within PDR by modeling best practices.

The PD/PT Regulatory Affairs Informatics (FPPR) team is looking for a highly skilled Delivery Service Manager, who will support the Submission Management systems area.  This candidate will be able to deal with a diverse and multicultural, global team in varied time zones, who is proactive, outgoing and detail- oriented with excellent problem solving, and written/verbal communication skills.

Further responsibilities are:

• Applies complex procedures and defined standards to meet current business, customer and technical requirements and leads others in resolution of complex problems.
• Leads specialist resources on technical issues within the domain on content and provides detailed analysis of the operations and opportunities for improvement.
• Develops business/technical critical know-how within area of expertise for the function and is familiar with opinion leaders in the field. Assists in the development of others know-how by passing on knowledge of tools and techniques.
• Supports day to day operations and / or implementation of projects within area of technical expertise, contributes to the implementation planning and may execute some aspects of that plan. Accountable for roll-out of new services or enhancement to existing services.
• Manages incident and problem management processes, release and configuration management according to ITIL. This includes continuous improvement for the management of the services. Acts as the initial point of escalation for incident, problem and change management for the Business Representative (e.g. Business Lead)
• Administers change control procedure and processes. This includes the management of the change control board and oversight of the approved change
• Is well-versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships.
• Is familiar with Statement of Work (SOW) and procurement processes
• Is customer-focused and able to track problems/issues to their resolution with the appropriate level of follow-up to the user community
• Builds and maintains good working relationships with the Business Representative and the client business base , monitors services and providing regular service reports to the FPPR management and business clients

The Informaticsteam is looking for a highly skilled Operations Lead, who will support the systemsthat enable the Sales & Marketing business teams.  In this role you will work closely with thebusiness leads, end user community, development teams, vendors and serviceproviders to provide the overall IT service. As service lead, the individual may also play other roles as requiredlike project manager and business analyst to ensure optimal service delivery.  This candidate will be proactive, outgoing and detail-orientedwith excellent problem solving and written/verbal communication skills.  The Operations Lead will have excellentcustomer relationship management skills with a service minded attitude and abilityto translate informatics terminology into business relevant language

Further responsibilities are:

• Supports day-to-day operations and / or implementation of projects within area of technical expertise, contributes to and executes implementation plans
• Manages incident and problem management processes as well as release and configuration management.  This includes continuous improvement for the management of the services.
• Acts as the initial point of escalation for incident, problem and change management for the business leads
• Administers change control procedure and processes. This includes the management of the change control board and oversight of approved changes
• Is well versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships
• Applies complex procedures and defined standards to meet business, customer and technical requirements and leads others in resolution of complex problems
• Leads specialist resources on technical issues within the domain and provides detailed analysis of the operations and opportunities for improvement
• Develops business/technical critical know-how within area of expertise.  Assists in the development of others know-how by passing on knowledge of tools and techniques
• Accountable for rollout of new services and enhancements to existing services
• Familiar with Statement of Work (SOW) and procurement processes
• Tracks problems/issues to resolution with the appropriate level of follow-up with the user community
• Participate in project teams to help identify solutions and requirements for new functionalities and performing impact analysis
• Builds and maintains good working relationships with the business leads and the user base, monitors services and provides regular service reports to Informatics and business leads

Summary of Position:

The non-interventionalprogram (NIP) Coordinator is the specific point of contact for requestsregarding NIPs.  The NIP Coordinatorensures that all NIPs conducted by Genentech are approved, tracked, andconducted in accordance with relevant regulations and company internalprocesses and procedures.

Job Duties/Responsibilities:

• Liaison with the BusinessUnits to ensure a proactive review and assessment of all proposed NIPs.
• Provide support to scopestaff handling NIPs by answering questions or providing advice on good NIPpractices as defined in laws & regulations, codes and internal guidelines& SOPs
• Ensure timely involvementof line management in case of violation of good NIP practices
• Create and maintaintraining for good NIP practices, regulations, codes and internal guidelines& SOPs
• Ensure scope staffawareness of ongoing changes to regulatory or local requirements, and new proceduresand policies on NIPs. Co-ordinate in-house and external provider training byliaising with other departments, external trainers, or running courses,including functional orientation/induction program for new employees
• Identify the need forcreating additional or updating existing SOPs or processes/working guidelineson good NIP practices
• Responsible for tracking of NIPs under their scope of responsibilityinto NIP database(s)
• Ensure each NIP has a program outline which details the nature of the program and safety data collection and reporting processes
• Proactively reportsconcerns/issues to the NIP Coordinator Lead toensure compliance with safety SAE and non-serious AE reporting requirements are met
• Ensure a quality control and reconciliation process is in place for on-goingNIPs and conduct a NIP risk assessment at least once a year as per globalSOP(s)
• Liaise with other NIPcoordinators and be a proactive member of the global NIP network (identify newNIP requirements, develop preventive and corrective measures against NIP risks,maintain and promote good NIP practices across GPS and affiliates)