The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for downstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

 

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as downstream frontline representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

 

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in the following areas;

·        Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·        Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

...

Regulatory Technology 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. Regulatory Technology Directors and their staff are assigned their responsibilities by varying PDR systems projects and systems maintenance support, as business needs dictate. Associate Directors typically have direct and indirect reports and oversee and guide Regulatory Technology management and staff in user needs analysis and requirements gathering, PDR systems project definition, development and implementation, and process design/redesign to support best-in-class PDR operations and compliance. Associate Directors may lead the site and/or regional Regulatory Technology management team and are standing members in the site and/or regional Regulatory Technology Leadership Team. Associate Directors may also have additional responsibilities, as assigned, to perform the role of Site Lead for the assigned function or cross-functionally for PDR. Associate Directors, by comparison to Directors, are either new to the director-level position, or assigned smaller and/or less complex business areas to support.

JOB DESCRIPTION- PRIMARY DUTIES AND RESPONSIBILITIES

1. Cross-Functional Teams

• Is a standing member of the site and/or regional Regulatory Technology Leadership Team
• May lead the site or regional Regulatory Technology management team. Drives best practices and operational excellence within the department and cross-functionally and ensures timely communication and information dissemination across the department and beyond
• As needed, ensures appropriate appointment of staff members as ad hoc members in Regulatory Affairs Functional Teams (RAFT); driving and ensuring effective and efficient support for cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
• As assigned, self and staff may act as standing or ad hoc members of other teams for special or ongoing initiatives and projects

2. Staff Leadership & Development

• Develops and manages annual and/or longer-range departmental budgets and resource plans
• Tracks departmental expense budgets to ensure compliance with agreed parameters
• Where applicable, self and team may participate in the negotiation with and commissioning of external vendor partners to support the work of Regulatory Technology
• Accountable for appropriate resourcing decisions for assigned Regulatory Technology function and staff
• Cascades strategic and other relevant goals and objectives as well as budget and other resources to direct reports
• Leads recruitment, hiring and on-boarding for his/her staff member positions. May include, as needed, short-term contract personnel
• Plays a lead role in creating and maintaining a positive work environment by encouraging mutual respect, innovation and accountability at all levels (global, site, functional, projects/programs)
• Ensures that performance of assigned Regulatory Technology management and staff is proactively managed and that management and staff are appropriately trained, developed and coached to maximize their contribution and ensure compliance with Roche and regulatory guidelines and standards. Accountable to ensure assigned management and staff consistently complete their deliverables and other responsibilities on-time, on-target and within-budget
• Conducts ongoing performance management and completes the required steps of Roche’s performance management process and cycle. Includes individual development plans/career discussions and actively contributing to performance calibration, talent management and succession planning processes
• Actively participates in management and skill development programs for continued professional development
• Leads routine and ad hoc meetings with assigned Regulatory Technology management and staff
• Identifies, recommends, assigns or otherwise undertakes special projects that further the success and effectiveness of Regulatory Technology and/or PDR overall
• As needed or otherwise appropriate, acts as a substitute for his/her manager in various meetings, communications or other forums
• Consistently complies...

Manager/Sr. Manager, Commercial Training & Development - Rheumatology

The Rheumatology Manager/Senior Manager in Commercial Training & Development (CT&D) is accountable for managing and leading a team of 5 Actemra and Rituxan trainers and support staff who develop and implement a learning & development curricula which supports CT&D, brand, and sales objectives. Managers/Senior Managers in Commercial Training & Development are accountable for ensuring the assigned team meets or exceeds their goals and objectives and maintains alignment and coordination with department and functional stakeholders. Key competencies include: building and leading teams, strategic agility, communication, and collaboration. Rheumatology, training, and sales experience preferred.

Example Duties and Responsibilities:

• Assesses existing learning & development curricula and offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May develop, manage or individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; enabling self, team, department and overall function with detailed partner/stakeholder input
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, specific programs and/or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development support
• Works with others to develop and implement an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate team's offerings and support strategies
• Works with others to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or other
• Works with manager and peers, and oversees team in such a way as to, continuously assess and evaluate learning & development plans and activities to ensure continuous, strategic alignment to meet or exceed internal business partner and other stakeholder needs and objectives
• Consistently monitors and supports team's work and associated work output. Regularly coaches, advises and gives further direction to help team members fine-tune and hone their work to meet or exceed assigned goals and objectives
• Ensures self and team members, where and when appropriate, seek regular internal client or other partner/stakeholder input into in-development work; does so to ensure maximum alignment to internal client needs, objectives and goals
• Consistently oversees the execution/implementation of team's work to ensure timely and best quality output. Manages similarly with any applicable external partners; ensuring their work is on-time, on-target and within-budget to meet or exceed assigned goals, objectives and other expectations
• Hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

...

The Manufacturing Site IT Lead is the primary IT point of contact for the Vacaville Biotech Manufacturing facility leadership team: an escalation point for issues, business partner on opportunities, communications channel between the site and Pharma Informatics and an active participant in the Global / Regional IT management of change process.

This position also has leadership and management accountability for two virtual teams: An Application Support team that focuses on the support of Local and Regional Manufacturing and Engineering solutions, and a Tools Team that develops and maintains small custom applications for Manufacturing Sites.

Primary Accountabilities

Engagement:

• Matrixed to a member of the Plant Manager’s leadership team, and expected to contribute cross functional leadership and expertise to the success of the site
• Expected to build and maintain close business relationships with site leaders and stakeholders
• Expected to understand the local Biologics manufacturing site business strategy, objectives and priorities, and communicate appropriately within Informatics
• Advise Site Leadership on Pharma Informatics policies and opportunities
• Represents the customer’s view in the overall Pharma Informatics portfolio discussions and informs them about portfolio decisions
• Represents Site in Manufacturing Site IT Lead forum, contributing to cross site initiatives as assigned

Service and Project Delivery:

• Collaborates closely with the global delivery solution centers
• Develops and manages the Biologics manufacturing site Informatics portfolio in alignment with the global business objectives and governance processes
• Drives efficiency by utilizing globally defined best practice processes for Informatics operations
• Follows defined working processes and standards (Corporate, Biologics and Informatics) in the execution of daily duties and job function
• Aligns local activities and solutions with global ones and vice versa
• Works with Global IMs and Solution Center Managers to create solutions and initiate projects
• Ensures true end-to-end services
• Manages local vendor relationships, service levels and contracts where applicable
• Monitors services and provides regular service reports to the Global Information Managers, delivery and business clients

Alignment:

• Ensures standardization of applications by promoting shared processes, data harmonization and architectural compliance where possible
• Ensures that the shop floor and lab systems are optimally operated at the site
• Ensures the applications fit the needs and capabilities of the customer’s organization and SLAs are defined and supported as well as systems remain validated and documentation is maintained
• Ensures standardization of applications and promotes shared processes, data harmonization and architectural compliance where possible

Management:

• Coordinates the analysis, design and development of Tools projects, upgrades, and the deployment of new services or products
• Manage support of ~40 local, regional and global applications 
• Manage production and internal escalations
• Manage M&E (Maintenance & Enhancement) process for Local / Regional Manufacturing and Engineering systems 
• Manage external consultants and near-shore (e.g. ADMD) resources to supplement team
• Manage, coach and support development of individual team members’ careers
• Appraise team and individual performances
• Manage operational and project budgets of the team
• Participate in the Leadership Team for the PT Biologics IT organization

...

Lead cross functional project teams to:

- Deliver project goals on budget and on schedule
- Develop customer requirements into an approved project charter
- Analyze business, process and systems performance, and identify improvement opportunities
- Make recommendations to Management based on business case and analyses
- Lead decision making support and make recommendations regarding best options
- Communicate proactively with stakeholders regarding progress, issues and plans for resolution
- Develop and use project plans to coordinate participants and track and report progress
- 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

Competencies:

Job Knowledge and Scope – Applies extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems. Determines methods and procedures on new assignments (defines scope and approach). Occasionally creates course material and delivers advanced lectures to internal and external audiences.

- Collaborative Leadership – Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity, able to create order from chaos.

- Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes.  Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations.  Makes quality decisions and resolves problems rapidly. Asks “what can I do to help?”.

- Communication – Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.

- Planning/Organization – Excellent planning and prioritization skills with the ability to multitask and adapt.   Able to synthesize large amount of information.  Able to deliver results despite shifting environment.

- Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.  Innovative and effective in solution development, risk mitigation, and execution.

- Customer focused – Partners with customers, looks ahead to predict future customer needs. Manages expectations.
- Supervision – Work is performed under limited direction. Establishes own work priorities and timelines. May provide guidance and coordinate work activities of other personnel.

- Job Complexity & Decision-making – Develops solutions to a variety of complex problems and initiatives. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data require an in-depth evaluation of variable factors, including inter-organizational impact.

- Interaction – Interacts with senior internal and external personnel on significant matters. Represents the organization as a prime contact on initiatives and projects.  Can facilitate RCA's, lessons learned, K-T analyses and FMEA's.  Can facilitate strategic discussions with leadership teams.

...

Group Product Manager, Erivedge Key Customer Team

The Group Product Manager (GPM) will report to the Erivedge Marketing Director. This position offers the opportunity to lead the brand analytics, access initiatives and key customer relationships for Erivedge, a first-in-class hedgehog pathway inhibitor indicated for the treatment of advanced basal cell carcinoma (aBCC). The role will be accountable for tracking performance indicators, implementation of access-to-care and practice management tactics and thought leader engagement, while leading a team of two marketers. Specific responsibilities include development of quarterly business reviews, thought leader development, advisory activities, peer-to-peer promotions, managed care / access programs and providing appropriate commercial perspective to publication planning and medical teams.

Additional responsibilities of this position include: 

• Collaborate with MCCO to ensure understanding and execution of brand strategies within appropriate payer and field-based tactics
• Lead initiatives with MCCO to optimize patient flow from script to shipment 

• Manage development and implementation of thought leader strategies including major conference activities, internal management tools, and participation/involvement in key promotional activities
• Collaborate with field sales, TLLs, marketing colleagues on thought leader activities
• Collaborate with BioOncology partners for implementation of major meeting activities

• Collaborate with Medical Affairs, Clinical Science, and Advisory Board Services to manager advisor activities
• Lead data integration team toward developing and tracking key performance metrics in collaboration with market planning, marketing science, sales operations and forecasting/business analytics team
• Lead and motivate team of two direct reports and manage all activities and professional development
• Managing brand budgets 
• Maintain strong relationships with colleagues in research, clinical, medical affairs
• Actively participate in Oral Oncolytics and BioOncology initiatives and programs
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

Successful candidate should possess:

- Solid understanding of specialty biotech/pharmaceutical marketing and sales

- Solid experience with proven results in managing and motivating direct reports in a marketing role 

- Strong analytical and communication skills

- Direct experience managing through leader relationships and/or extensive knowledge access dynamics for part D drugs

- Proven ability to develop relationships with sales force and across departments for support of strategies 

- Proven ability to work in a fast-paced, collaborative environment which requires significant cross-functional and cross-brand coordination and teamwork

- Proven ability to work in teams and also work autonomously 

- Experience in working with commercial promotional review committees

- Proven track record of adhering to timelines and budgets

...

The ERP Demand & Production Services team is part of the ERP Demand-to-Supply (D2S) team within the Pharma Informatics Shared Platforms & Applications - ERP organization. This global team provides SAP and non-SAP-based solutions and services to our Global Supply Chain (Clinical & Commercial) business function. These solutions include: SAP’s APO (Advanced Planner & Optimizer), SNC (Supplier Network Collaboration), OER (Object Event Repository), AII (Auto-ID Infrastructure), and other vendor and custom solutions, along with integration to various manufacturing and other supply chain solutions.

The Head of ERP Demand & Production Services will provide global perspective and partnership and leverage knowledge across the Roche Group in order to better enable our Supply Chain business to achieve their goals. They will also drive customer demand management, people management,  project management, solution development, maintenance, enhancement,  and operational support. In collaboration with the business, they will develop strategies and plans that maximize the ROI from the use of our solutions.

The Head of ERP Demand & Production Services is accountable for the management and leadership of a team of IT professionals located in Basel, Switzerland and South San Francisco, California, USA, along with the management of shared services resources in Poland and outsource resources - both onsite and offsite. This position can be based in Basel, Switzerland or South San Francisco, California.

As a member of the ERP D2S Leadership team, the Head of ERP Demand & Production Services will: 

• Develop, manage, communicate, and plan effectively to ensure alignment with, and clear understanding of strategic and operational goals of our customers.
• Collaborate  with IT colleagues to ensure that workforce plans, vendor management, budget management, customer change management, staff performance management and other internal processes are conducted professionally and in the best interests of our customers, teams, and other stakeholders.
• Keep abreast of technical developments that may have application in the Pharma / biotech  industry, and promote the use of those that provide strategic business benefits.
• Govern, prioritize, and deliver a portfolio of projects that are aligned with the our business strategy and technology roadmaps.
• Ensure team actively manages incidents, service requests, and change queues in compliance with Roche processes.

...

Purpose:

The Head of Small Molecules Development Products, North America, in External Quality is accountable for the development and deployment of the Quality strategy for the selection and operation of Contract Manufacturing Organizations (CMO) that support the gRED Small Molecules development portfolio. Accountable for all aspects of Quality related to these CMOs to include: Quality Systems, Product Quality Operations, Process Qualification and Validation, cGMP Compliance, Risk Management, GMP Audit and Inspection Readiness. Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold Roche’s reputation as a reliable, high quality supplier of IMP products. In collaboration with other PTx and gRED functions, ensures appropriate measures are employed to fulfill the requirements of phase appropriate cGMPs, international standards and requirements. Responsible for risk management utilizing risk management tools for each CMO within group’s scope. Accountable for the management of Quality and Compliance within the group to include: staffing, talent management, performance management, financial performance, and execution to meet strategic and operational objectives.

Responsibilities: 

* Management of the North America Small Molecule Development Products Group

* Staff and assign Quality Managers to lead quality teams for IMP products after approval to proceed to development utilizing CMO manufacture 

* Lead Quality Managers in the implementation and execution of Quality processes for the selection, implementation, and ongoing management of development CMOs

* Accountable for the Quality and Compliance Status for all CMOs within the group’s scope of operations 

* Establish and manage performance metrics for the Key Performance Indicators (KPI) 

* Determine staffing requirements and provide input to department budget

* Establish individual goals for direct reports, provide performance management for direct reports, and conduct talent management in accordance with Roche standards and procedures

* Accountable for the deployment of the Roche PT Pharmaceutical Quality System (PQS) standards and requirements for outsourcing for all Small Molecule Development CMOs used for the gRED portfolio, ensuring appropriate risk assessment and mitigation for identified gaps

* Participate in Joint Steering Committees through the established Governance processes as required. Define quality actions to be resolved and/or escalated to Roche senior management at the Executive Steering Committees.

* Accountable for approval of:

* Quality Agreements Appendices, such as PSRs, for Development CMOs on behalf of Roche Quality

* IND and IMPD Manager Level reviews

* Major Deviations or Changes in Roche Approval systems

...

Main Purpose of the Position:

• Supervise and develop Environmental Quality Control and Microbiology (EQCM) staff that perform routine and moderately complex testing activities and follow cGMP regulations and Genentech standards.  

• Supervise performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:

• Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.

• Coach and develop staff by providing an environment that encourages ongoing personal and professional development.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.

• Assign activities to staff.

• Routinely monitor progress and completion of assigned staff activities.

• Supervise routine activities of moderate complexity.

• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

• Meets scheduled performance of 95% on time.

• Perform any other tasks as requested by Senior Management to support Quality activities.

Technical Duties/Responsibilities:

• Provide technical and compliance guidance on test methods.  

• Review, evaluate and approve test data against established criteria.

• Provide input for the resolution of Out of Specification (OOS), complaints, discrepancies and Corrective and Preventive Actions (CAPA).  Design testing strategy to support investigation.

• Review technical / investigation reports and provide input as requested.

• Identify potential improvements to Quality Control systems and procedures gaps, and implement improvements as directed.

• Provide guidance and coaching in the application of cGMP throughout Quality Control operations.

• Receive and provide training.

• Participate in collaborations to support complex and/or multi-site projects.

• Participate in internal and external audits and regulatory inspections.

• Provide input and guidance to authors of protocols and reports.

• Review and approve proposed changes to systems, test procedures, test methods, procedures and submissions to regulatory agencies.

• Participate in validation and qualification studies.

...

The general purpose of the Senior Manager, Commercial Training & Development role is to help structure and directly manage the development and implementation of appropriate and aligned learning & development in support of assigned functions across Commercial Operations. As such, the Senior Manager, Commercial Training & Development manages a team of assigned trainers, and/or instructional designers and other project-based or administrative staff, and does so to ensure the assigned team meets or exceeds their goals and objectives. 

The Senior Manager, Commercial Training & Development may be assigned core sales, product knowledge, marketing, or other core Commercial Operations functional skills development curricula in support of assigned Commercial Operations functions, or he/she may be alternatively assigned core aspects of a Commercial Operations-wide development segment such as cross-functional leadership or management development. Incumbents in the Manager/Senior Manager, Commercial Training & Development role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. 

As a manager of others, the Senior Manager, Commercial Training & Development is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. 

MAJOR RESPONSIBILITIES ¿

* Has a thorough understanding of the applications and benefits of Genentech's products.

* Determines the most effective approach to meet product learning needs of the business. Applies instructional design principles and adult learning principles to enhance content delivery. 

* Performs detailed needs assessments in coordination with Brand Sales and Clinical Trainers. 

* Translates business needs to training products and programs.

* Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.

* Researches the issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products

* Oversees the preparation of training products and programs such as classes, workshops, learning modules, e-modules, and other job aids and materials for distribution to CT&D partners and program participants.

* Skilled at group facilitation and group learning exercises.

* Implements learning and development programs based on needs assessed.

* Designs and implements metrics to measure training programs and training impact, effectiveness, appropriateness, and utility.

* Filters and distributes educational resources to CT&D partners and other appropriate audiences while remaining

contentious of legal and regulatory parameters.

* Collaborates with all CT&D partners: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure training needs are met.

* Collaborates within CT&D to ensure consistency, avoid redundancy and thereby enhance training programs.

...

Group Market Planning Manager Global Product Strategy

Leads a team of 3 International Business Analysts (IBA) that participates actively in global commercial planning efforts by providing unbiased, objective, in-depth information about current and future markets, product performance, customers, and competitors. Additionally, he or she identifies critical business issues and opportunities for growth, collaborates with Roche/Genentech teams, and works to embed an external market point-of view into the strategic direction of the company. This individual will be both a manager and an individual contributor.
This role is a global role based in South San Francisco and he or she is required to travel nationally and internationally.

Key Accountabilities

• Provide an objective commercial viewpoint based on an in-depth understanding and analysis of commercial information.
• Lead team to proactively assess external marketplace/other related factors to support strategic decision-making
• Define/oversee various Strategic Analytics projects and other work completed by team
• Ensure provision of strategic insights/recommendations; enabling business¿partners/stakeholders to make the best-informed decisions regarding their strategies, plans, etc.
• Develop/manage operating budgets and other resource requirements
• Hire, develop and oversee the work of direct/indirect reports
• Comply with all laws, regulations and policies that govern the conduct of Roche/Genentech ¿activities
• Business travel, by air or car, is required for regular internal and external business meetings¿
Capabilities:
• Effectively manage a team of highly driven professionals. Motivate, develop, and retain top talent.
• Grasps key issues quickly, understands the "big picture" and links market research findings to larger issues.
• Uses rigorous logic and methods to solve difficult problems with effective solutions.
• Can see hidden problems; looks beyond the obvious and doesn't stop at the first answers.
• Uses creativity and ingenuity to develop solutions to complex problems, formulates strategies and approaches which may fall outside historical norms.
• Strong commitment to quality. Consistently and thoroughly reviews work for accuracy before sharing with a wider audience. Delivers final products that are well vetted and reliable.
• Demonstrates persuasive written and verbal communication skills. Is effective in a variety of presentation settings. Is comfortable around higher management.
• Can deal with ambiguity and act without having the total picture, is able to effectively pose questions in order to “tease out” information required for decision-making. Can handle risk and uncertainty
...

The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for upstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as USFL representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

 

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in two areas;

·         Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·         Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

...

Supervisor1/ Supervisor 2

RESPONSIBILITIES:
Ensure success of operations on a day-to-day basis. Direct, plan, organize and control operations. Primarily responsible for ensuring required levels of safety, quality, and productivity are met. Support Operations by working effectively within the management team to execute goals, objectives, and tasks to achieve desired results. Direct shift operations by planning, prioritizing tasks and assignments, and deploying resources in alignment with the production schedule. Provide leadership and technical oversight to staff members. Develop and/or improve staff capabilities in response to
department needs and expectations. Provide cross-functional coordination and issue resolution across operations, other groups and/or projects. Anticipate potential problems or vulnerabilities in processes or systems and suggest solutions. Manage the implementation of solutions to increase efficiency and effectiveness of the shift towards meeting department goals....

The Head of Planning  is responsible for leading and managing the PTD planning network globally, establishing a vision and mission for the group with roles and responsibilities for local and global activities, establishing and managing PTD planning business processes in close collaboration with PTDx functions, portfolio reports and interfaces with the PlanSource Steering group, ensuring resource allocation transparency. Interacts closely with PTD functional planners, PTD finance, TDLs and TDT PMs, PTD leadership team and key stakeholders within the Research and Early Development, Development and Technical Operations organizations to ensure strong partnership, excellent communication flow, resolve issues and understand inputs affecting the technical development planning activities. This position requires strong leadership, collaboration, negotiating and influencing, strategic thinking, organizational and communication skills.

MAJOR RESPONSIBILITIES

• Lead and manage the global PTD Planning  group. This includes establishing a vision and mission for the group and the global PTD planning network with clear roles and responsibilities for local and global activities, establishing and maintaining PTD planning business processes and planning operations in strong partnership with the PTD functional planners, and conduct regular alignment meeting with the PTD planner community ensuring resource allocation transparency, PTD finance, TDLs and TDT PMs, yearly maintenance of generic plans in Plansource with eRAM update, establishing training for planning functions and groups within PTD, resource planning data analysis and scenario planning to support PTD strategy initiatives. Supports budget cycle from the PlanSource perspective
• Accountable for projects and portfolio reports and portfolio analysis. This includes maintenance of reports, creation and/or retirement, and distribution of reports to meet the business needs of PTD and its stakeholders. Creates strong partnership with Global Portfolio Management aligning the PTD reporting with Corporate portfolio.
• Represents PTD on PlanSource Steering group and drives for PlanSource operational processes updates and change management within PTD.
• As a member of the PTDM leadership team, works collaboratively to establish priorities and directions for PTDM globally. Contributes to the development of department business initiatives and facilitates their implementation.
• Fosters a culture of high performance, trust and collaboration across all PTD planning stakeholders. Builds and cultivates a strong network among PTD functional planners, Finance groups, PlanSource expert groups, TDLs and strengthens partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.  Helps to surface, analyze and resolve planning related issues and resource conflicts.
• Recruits, retains and develops talent. Establishes and implements training and development plans as required, providing constructive feedback as well. Supports the creation, use and continuous improvement of standard planning systems, tools and processes. Interacts closely with TR&D functional leaders and key stakeholders within the Research and Early Development, Development and Technical Operations organizations.

...

• Primarily accountable for ensuring the technicalsuccess of the maintenance  operations and the performance management of aworld-class maintenance  organizational unit associated with thecommercial manufacture of all GMP products.  
• Manage activities of designated functional unit inmaintenance  shift or unit supervisors/leads who direct daily activities.  
• Identify the technical, procedural andequipment issues that may compromise production and compliance, working closelywith cross-functional groups to identify and implement solutions.
• Manage and resolve technical andcompliance issues with Quality, Manufacturing, Manufacturing Sciences andTechnology, Reliability Engineering, Engineering, & EH&S.
• Develop weekly and monthly goals andschedules and set priorities for supervisors/leads. Evaluatesupervisors’/lead’s performance; ensure supervisors’/lead’s fair and timelyevaluation of the performance of their staff.
• Responsible for identifying andimplementing improvements in staff development in areas such as cGMP training,technical skills, safety, performance management.
• Implement and follow through oncorrective and preventative actions for variances.
• Represent the department in reviewingand approving all maintenance related documentation requiring approval such asprocess validation protocols and final reports, planned and unplanned variancereports, documentation change requests, engineering and facility changerequests, and validation protocols.
• Ensure that all operations areperformed with 100% compliance to documentation cGMP standards.
• May prepare department budgets andstrategic staffing plans.
• Assist Associate Director with settingbusiness goals and cross-functional deliverables.
• All employees with jobs that requireaccess to the Warehouse must be able to pass the Transportation SecurityAdministration (TSA) Security Threat Assessment (STA).
• Promotes a safety culture that supportcontinuous improvement in the EHS management system through activecommunication and functional area participation in site safety teams ensuringthe safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt.
• Manage assignments that are complex innature where independent action and a high degree of initiative are required inresolving problems and developing recommendations.
• Manage problems where analysis ofsituations and data requires an evaluation of intangible variables.  
• Exercisesindependent judgment in developing methods, techniques and evaluation criteriafor obtaining results.

...

Group Strategy Manager 

 
The  purpose of the Group Manager, Strategic Pricing & Contracting role is to oversee and/or develop pricing and contract strategies for the assigned therapeutic areas and/or customer segments that optimize the value of Genentech's portfolio, which includes leading cross-functional strategy development teams, building effective relationships across all franchises relevant to the assigned therapeutic areas and/or customer segments and scenario analysis/modeling for overall financial and legal viability, as well as ongoing pricing and contract performance assessment/analysis.

1. Act as a lead subject matter expert from Strategic Pricing & Contracting
2. Play the lead role in cross-franchise assessment and integration of pricing and contracting strategies, plans and tactics; includes providing a leadership perspective and strategic pricing and contracting inputs into all business plans relevant to the assigned therapeutic areas and/or customer segments
3. Provide a leadership perspective on Genentech pipeline developments, as these relate to pricing and contracting strategies development and strategic options
4. Work effectively with Genentech executives to transfer and leverage learning across brands
5. Act as the lead contact on all internal and external communication regarding pricing and contracting strategies, philosophies and practices for the assigned therapeutic areas and/or customer segments; includes responding to internal/external inquiries regarding Genentech's pricing and contracting philosophies and practices
6. Develop internal/external reports, presentations and training to educate others in Genentech's pricing and contracting philosophies and practices
7. Take a leadership role in training other team members and internal partners/stakeholders in pricing and negotiating theory/application
8. Support manager in longer-range departmental planning; determining resource requirements, headcount, infrastructure, systems, tools and the like
9. Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies

...

Purpose

In partnership with senior leadership, responsible for strategic direction and execution of medical communication plans for marketed products, pipeline molecules, and therapeutic area support. Oversight for MC scientist teams. Ensures product specialist resources are positioned to support current and future company needs. Accountable for the long-range financial planning and resource management for med comm product support.  Liaison responsible for directing and influencing corporate groups to achieve shared goals and objectives.

Job Description:

• Oversight for daily operations of the MC scientist teams, including responding to unsolicited requests, creation and maintenance of document response library, support for product launches, internal team support, and responding to label changes

• Provide oversight and leadership to the management team including strategic planning and tactics aligned with corporate and product priorities, champion department goals, and brand planning

• Year over year finance and resource budget planning as well as future resource forecasting for therapeutic area

• Accountability for representing MC at multidisciplinary senior-level cross functional committees including: Label committee (LC), reprint dissemination committee (RDC), healthcare compliance committee (HCC), patient communications committee (PCC), medical communications leadership team, and other committees where relevant; safety sub-teams (SST), promotional review committees (PRCs), Medical teams, major scientific meeting taskforce teams

• Career development of future leadership and succession planning for manager teams. Empower his/her staff to make sound decisions, and delegate as appropriate

• Develop and maintain collaborations with multiple corporate partners including Roche global, Novartis, Merk-Serono, Abbott, Biogen-Idec, and OSI pharmaceuticals

• Ensuring effective and efficient cross-product and cross-activity support via senior leadership collaborations

• Maintain awareness of the present state of business and needs by maintaining relationships with all relevant areas within and external to the Medical Affairs Organization

• Interacts and represents MC department with internal customers including but not limited to: Sales, Marketing, Clinical Operations, Clinical Science, Regulatory, Legal, and Safety.  Frequently represents MC outside of department  

...

GENERAL POSITION SUMMARY/PURPOSE:

Roche’s PDS organization is structured by product development phases, therapeutic areas and sites.  PDS enhances healthcare for patients by understanding and communicating the safety profile of Roche medicines to optimize their benefit-risk profile. Principal Safety Scientists in the Licensing and Early Development (LEAD) group supporting the Genentech Research and Early Development (gRED) organization will be responsible for the oversight of personnel and activities focusing on safety-related operational support of the early development teams within gRED. Principal Safety Scientists will be responsible for both the coordination of these activities and supervision of Clinical Safety Associates (CSA) within the LEAD-gRED group, and for individual contribution to these activities for a portion of the portfolio.  The Principal Safety Scientist will report to the Associate Head of LEAD-gRED Safety Science.

Cross-Functional Team Membership 

• Ensure appropriate coverage for all Protocol Execution Teams (PET/CPET) or Study Management Teams (SMT) for assigned molecules via supervision of CSAs and via individual contribution where needed.  Coordinate and liaise with the LEAD_gRED Associate Head and the gRED PET Leaders (PETL/CPETL) to ensure coverage of the necessary activities.  
• Proactively interface with gRED Protocol Execution Team Leader (PETL) to identify operational support needs for Safety Management Team (SMT) and/or Protocol Execution Team (PET) and prioritize coverage as needed
• Acts as single point of contact for CROs and affiliates with respect to safety operations activities
• Coordinate with PETLs to provide support to CRO regarding scope of work, requests for proposals, safety management plans, and kick-off activities

Product Development Safety-Related Operational Support for gRED early development teams

• Demonstrate advanced knowledge of safety reporting concepts, focused on standards set out in ICH and FDA guidelines for drug safety reporting requirements.
• Assists gRED Clinical Operations with ensuring appropriate inclusion of safety reporting information for investigator and site training; Independently performs clinical trial reconciliation (as applicable). 
• Review and address deviations in safety reporting sections of protocols vs protocol template; review and implement protocol specific reporting requirement e.g for Adverse Events of Special Interest; and ensure corresponding database and reporting processes are in place (e.g. IMP designation, appropriate listing of protocol in ARISg).
• Contributes to safety reporting sections of periodic reports (e.g. IND Annual Report, DSUR).
• Provide general assistance and expert input to the LEAD-gRED team members with the PDSS-PDSO interface. 

Process

• Demonstrate knowledge of requirements of clinical trial processes including CRO management, investigator and site training needs with respect to safety reporting, and safety data exchange agreements (SDEA).
• Coordinate SDEA process to ensure liaison between PET, PDSO representatives, and DSL members.
• Expected to play an advanced, expert role in PDS’s/PDSS’s policies, procedures, processes and other infrastructure developments.

Managerial activities

• As needed or otherwise appropriate, assists with recruitment, training, and/or coaching of new or less experienced PDSS staff members. 
• Ability to mentor and supervise CSAs.
• Define port-folio responsibilities for CSAs and set clear priorities.

Other

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of the LEAD-gRED early development safety organization to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned activities.
• Maintains the highest standards and levels of knowledge in the specific areas assigned.
• Completes and/or leads other special projects, as and when assigned, or otherwise requested.  Expected to contribute to PDS and PDSS beyond the bounds of his/her position and products; including leading and/or participating on cross-functional teams and work groups. 
• Provides additional support to his/her manager, and others, as needed. 
• Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines.

...

The Network Operations Manager will be responsible for providing leadership and technical guidance to a team of Network Engineers throughout North America. He/She will ensure timely response to all alerts, resolving or escalating issues as appropriate while working closely with internal customers to assure continued quality of service. The Network Operations Manager will lead various transformative Network initiatives (Network redesign, infrastructure upgrades, new buildouts), both strategic and tactical in nature, that will address our most important challenges including scalability, stability, and an increasingly complex network. He/she will manage the network in accordance with identified service level agreements (SLA), KPIs, policies, and procedures.  This individual is key in maintaining the highest level of service for our customers, both internal and external.  Additional responsibilities include:

• Delivery services include long range planning, project management, internetworking, network monitoring, capacity planning, asset management, problem management and change management.
• Project responsibilities include managing the North America Network project portfolio approval process; managing project managers and their project activities; monitoring project status; acting as an escalation point for risk mitigation and issue resolution; and tracking project deliverables, schedule and budget to ensure successful project outcomes. 
• Develops annual budgets, and life cycle maintenance projects in order to maintain the corporate network infrastructure.
• Works with our Network Architecture and Engineering organizations to develop initiatives to ensure the strategic fulfilment of business needs, lifecycle management, and continuous improvement, as well as overall customer experience and satisfaction for a specific solution.
• Is responsible for leading (and providing direction for) many vendor initiatives, contracts, and service negotiations. Works closely with vendors, monitoring service delivery, evaluating new technologies, products and services to better position the company from a data networking perspective.
• Constantly reviews and refines support documentation, processes, and procedures. 
• Reports on SLAs and metrics for the performance of the network

...

Sr. Competitive Intelligence Manager

 

The Sr. Competitive Intelligence Manager (“CIM”) participates actively in supporting Genentech's US commercial planning efforts by providing objective, in-depth information about current and future markets and competitive forces.  The CIM acts as a strategic advisor to the US commercial teams with deep expertise in current and future competitive drivers in the marketplace as well as functional expertise in how to use CI to develop competitive strategies.

• Provide an objective commercial viewpoint based on an in-depth understanding and analysis of commercial, clinical, and scientific competitive information.  Make recommendations on brand strategy that prepare the brand for a competitive marketplace.
• Liaise with global CI counterparts to ensure up-to-date competitive intelligence and assumptions are shared with all appropriate US teams (includes congresses, news flashes, pipeline updates, therapeutic area landscape reviews)
• Collaborate with brand to plan for competitor launches by co-planning local strategy wargames and supporting rigorous competitive readiness plans.
•  Lead competitive threat assessments to develop rigorous team assumptions about key competitors; ensure local assumptions are consistent with global assumptions.
• Provide situational analysis support for quarterly business reviews, brand planning, launch readiness reviews, etc.
• Field intelligence facilitation, including managed care teams
• Work on innovative programs to increase the value of competitive intelligence processes and practice, and analyze the success of these programs.  Liase across the broader Market Analysis & Strategy organization to deliver holistic analytic insights to the brands.  Inform, communicate, and collaborate with MA&S partners.
• Manage one to two direct reports, which will include ongoing coaching and development discussions with tangible action plans for leveraging strengths and addressing areas of growth.

 

...