HER2 Brand Trainer

Brand Trainers in Commercial Training & Development use in-depth clinical and sales knowledge of the relevant therapeutic area and associated disease state(s)/indication(s), as well as general field-related experience, specific product and marketplace knowledge, to facilitate sales and clinical education training sessions for assigned employee/management groups. Brand Trainers work within a core learning & development support team, made up of their managers, instructional designers, and other project or administrative staff. These teams work closely with internal and external partners/stakeholders to ensure best fit and alignment of developed/implemented learning programs and other offerings.

Example Duties and Responsibilities:

• Works with others to assess existing learning & development curricula and specific programs and other 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 individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; providing detailed partner/stakeholder input that helps shape the direction, specific offerings, as well as content and facilitation methods/structure for ultimate design and facilitation alignment
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, programs or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development plans, programs, and activities
• Translates annual or other cycle learning & development plans, programs & activities into a scheduled calendar of specific sessions/dates for facilitation. Supports manager, peers, team members and others however necessary to finalize and disseminate such calendars, as well as respond to any internal client or external partner questions, concerns, or other comments
• As and when requested, supports others in the development and implementation of 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 department's offerings and support strategies
• Actively pursues continued education and awareness of field, product, disease state(s)/indication(s) and surrounding marketplace changes/developments, and uses where appropriate to incorporate into program and other learning event/activity facilitation, as well as provide such information to manager and team members for continuous departmental review/assessment of existing learning & development offerings
• Works collaboratively with manager, peers and/or other team members to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or others
• Uses approved learning & development plans, curricula, schedule/calendar, specific programs and activities for assigned responsibilities to proactively learn program/other activity content and prepare for expert facilitation. Channels questions, other needs or challenges - in advance - to the appropriate partners; further ensuring full and exacting preparation for expert delivery of assigned learning/development content
• As approved, conducts regular field visits, working with field staff and management one-on-one or in teams. Provides field consultation, team and/or individual coaching and development; enabling hands-on learning/development support to the assigned employee/management groups
• Continuously assesses and evaluates impact and overall effectiveness of facilitation responsibilities. Does so by consistently reviewing learning program participant evaluations, as well as soliciting additional or other feedback, extracting key themes, patterns and opportunities and channeling such to the appropriate internal partners or stakeholders
• Works with peers/team members to ensure maximum leverage of existing resources, tools, programs, content, etc.
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

...

A position is available for an Engineer/Research Assistant(N5) in the Purification Development department. The successful candidate willsupport the development and implementation of recombinant protein purificationprocesses from laboratory to manufacturing scale.  This will include process optimization andproduct characterization as well the support of high throughput experiments andlab automation activities within the Purification Development department.  Activities will include the development ofhomogenization, centrifugation, chromatography & filtration operations, analyticalmethods such as electrophoresis and HPLC and the design and execution of highthroughput experiments using robotic systems....

We are seeking a highly qualified and motivated individual to join the Small Molecule Pharmaceutics and Delivery group at Genentech. The candidate will be responsible for conducting pre-formulation and formulation evaluation of research molecules and clinical development compounds, such as solubility measurement, stability test, recrystallization, granulation evaluation, tablet development. He/she will also work on characterizing salts and polymorphs of small-molecule compounds; developing pre-clinical dosing formulations and supporting Discovery Biology, Efficacy, and Safety Evaluation of new chemical entities. The individual will be involved in formulation development in support of Clinical trials, such as excipient screening, prototype and market formulation development and technical transfer, and solid state stability monitoring.
...

GCP experience required for consideration

 

Position Purpose

The Inspection Specialist supports the Roche/Genentech Pharma and gRED/pRED organizations by coordinating, managing, and preparing for Good Clinical Practice (GCP), Pharmacovigilance (PV), and Investigator Site inspections conducted by global health authorities.

Major Responsibilities and Accountabilities

• Coordinates scheduling and logistics for inspection related activities.
• Collaborates with other Pharma / gRED / pRED functional areas for activities related to inspection preparation.  Activities include, but are not limited to, preparation of relevant materials and conducting inspection related training.
• Participates in pre-inspection visits of investigator sites ( approximately 20% travel).
• Participates in health authority inspections and helps ensure that roles and responsibilities have been defined and assigned for each inspection.  Assumes a role as required by the scope and nature of the inspection.
• Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
• Assists in the preparation, conduct and management of mock inspections conducted of Roche/Genentech functional areas.
• Assists in developing and maintaining policies, standard operating procedures (SOPs), and guidelines for preparation and conduct of inspections within Roche/Genentech Pharma.
• Assists in preparing periodic summary reports and trend reports related to Roche/Genentech inspections.
• Develops and maintains expertise in international GCP regulatory requirements, international PV regulatory requirements, and policies, SOPs and project-specific procedures within Pharma applicable to the clinical trial methodology and Pharmacovigilance processes.
• Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Roche/Genentech.
• Responsible for the coordination of Inspection Readiness (IR) modules and if required provides a country-specific / function-specific summary report.
• Provides support to the IR Program Manager.
• Provides support to and communicates with Inspection Readiness Key Contact (IRKC) personnel globally.
• Assists in identifying needs for updates to training materials, IR modules and all documents required for the IR program.

...

The candidate will be working in the design, performance and analysis of virus clearance studies, evaluating virus removal by protein recovery processes. Candidate will execute chromatography and/or filtration processes and perform Q-PCR, or cell-based, assays. Candidate will be responsible for scaled-down chromatography and filtration of the recovery process, as well as virus nucleic acid purification and quantification. Candidate will write GMP protocols, summary reports and execute validation studies. Depending on the business needs, candidate will support the development and implementation of recombinant protein purification process from laboratory to manufacturing scale.  The work may include purification process development, optimization, characterization, and validation. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation. The successful candidate will also collaborate with many different functional groups and work on the development of state-of-the-art technology on viral clearance or protein purification.

...

Responsibilities:

The Safety Assessment Division of Genentech is seeking a toxicologist with 0-3 years experience in general toxicology and an interest in human health risk assessment. This position will report to the Director, Product Quality and Occupational Toxicology.

The Associate Scientist will conduct analyses of available data and generate documentation to provide guidance for decision making to product quality, product process, drug development, and environmental health and safety (EH&S) teams. Examples of specific duties include conducting health-based risk assessments for active pharmaceutical ingredients (small and large molecule), process-related impurities, process residues, extractables and leachables, and small molecule intermediates. Additional duties involve the evaluation, interpretation and communication of available scientific information for active pharmaceutical ingredients and incorporation of these data into documentation in compliance with hazard communication requirements, the development of occupational exposure limits (OELs), and MSDS maintenance for Genentech's products in collaboration with EH&S. This is an excellent opportunity to gain
early entry to an industry position with a company that develops novel proteins and small molecules for the treatment of unmet medical needs.
...

Under the direction of the Technical Validation Associate Director the Senior Engineer will be accountable for leading teams and performing validation activities such as Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV). Able to collaborate with both plant and all network organizations seamlessly. Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity. Is able to provide the leadership necessary to maintain a high performance culture Responsibilities: Develop and manage the detailed project plans and timelines for the execution of validation activities. Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities. Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts. Present and provide rationale for the validation program during periodic audits and regulatory inspections. Procure and manage contractor support for outsourced validation and risk management assignments. Support the change management system for validated equipment, utilities and facilities. Prepare, review and approve relevant sections of regulatory submissions. Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA. Lead and facilitate Risk Assessment sessions. Provide input into investigations and change control with potential impact to the site risk profile. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. Mentor more junior validation engineers and train individuals on practices and procedures....

The Clinical Specialist, Franchise Sales manages anddevelops long-term relationships with physicians and other customers for thecustomer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) andtheir approved indications; helping external customers such as physicians,nurses, etc. learn about the benefits of the assigned GNE brand(s) in relationto the applicable therapeutic area/disease state.

 

Reports to: Division Manager, Franchise Sales

 

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

*Develops strong and long-term relationships with customersin all assigned accounts

*Presents the assigned GNE brands in a professional,compliant, ethical and effective manner; helping external customers understandthe benefits and use of GNE brands

*Monitors operating costs and compliance with territorybudget

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

*Business travel, by air or car, is regularly required 

...

Summary

Responsible for producing innovative Biotherapeutic medicine by interfacing with production systems and controls in a cGMP manufacturing environment, maintaining areas of responsibility in a high state of inspection preparedness, managing the performance of both manual and semi - automated warehouse processes to support manufacturing unit operations, collaborating with the network to implement multi-site process improvement initiatives/CAPAs and executing department objectives to support strategic goals.  Partners with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth, while utilizing a DMAIC data-driven, problem solving methodology to deliver tangible business results.  Responsible for business process analysis, design and optimization to enable the routine delivery of exceptional performance. 
 

Job Responsibilities

Applies a complete understanding of theories and concepts from one's technical/professional discipline to independently address a broad range of difficult problems.May determine methods and procedures on new assignments.

Essential
¿ Manage and resolve technical and compliance issues with Quality, Maintenance, Calibration & EH&S.
¿ Lead teams to execute internal/cross functional and network related projects that may include investigating, analyzing, formulating solutions, identifying improvement opportunities, documenting processes, training, process/system performance improvement and cascading results to management.
¿ Partnering with the customers, communicating/coordinating/bringing together key stakeholders, and delivering real value-add sustainable solutions.
¿ Act as SPOC for compliance or regulatory agency issues within the department
¿ Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross functional / network groups to identify and implement solutions.
¿ Implement and follow through on corrective and preventative actions for variances or regulatory observations.
¿ Represent the department in reviewing and approving all production related documentation requiring approval such as process validation protocols and final reports, planned and unplanned variance reports, documentation change requests, engineering and facility change requests, and validation protocols.
¿ Supports department to meet corporate goals and department objectives.
¿ Representing the department as the change agent.
¿ Deliver project goals on budget and on schedule.
¿ 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.
¿ 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.
¿ Work collaboratively with network to implement multi-site process improvement/CAPAs to mitigate compliance related risks.
¿ Ensure that all operations are performed with 100% compliance to documentation cGMP standards.
¿ Ensure maintenance of a safe warehousing work environment that complies with company and state regulations.
¿ Submit reports and compile data for trending and identifying problem areas.
¿ Collaborate with other departments to address issues and meet deadlines.
¿ All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
¿ Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.

...

The Position

Senior Finance Manager/ Finance Manager commensurate with experience

JOB DESCRIPTION:

Position is dedicated to supporting the financial management of the Oceanside Product Operations, part of the Roche Biologics Operating Unit (OU). The position will report to the Site Finance Head for Oceanside and is part of the Pharma Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization.  Beyond delivering on core job objectives, the position will have the opportunity to extend and lead other site and global network initiatives.

MAJOR RESPONSIBILITIES:

Responsible for the financial planning, analysis, and reporting activities of the Oceanside Drug Substance Manufacturing operations.  Act as a key Finance business partner to the functional heads of the operations and quality organization.  Develop strong business acumen and partner with the OU to help guide the business functions and support business and financial analysis.

Planning and Analysis

• Lead execution of planning exercises (forecasts, budgets, long-range plans) and coordinate efforts with business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and deadlines are met. 
• Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate. 
• Provide support for all budget reviews and submissions. 
• Identify and execute opportunities to improve operational results. Partner with OU management to achieve targeted costs and continuously improve. 
• Analyze spending and cost of production monthly and provide direction to OU management to balance risk and cost targets.
• Develop financial decision frameworks for operational issues and lead analysis through final recommendation. 
• Work with OU functions to provide input on the development and tracking of appropriate metrics and goals for planning horizon.
• Lead business case analysis for site and network initiatives.

Reporting

• Perform efficient and pertinent month-end reporting, including investigation of spending and manufacturing variances. 
• Prepare and present monthly financial results to site and financial leadership. 
• Use financial reporting to direct OU management toward areas of improvement or to surface operational issues. 
• Prepare and present quarterly capital spending updates to site and Technical Operations leadership. 
• Support Site Capital Governance Team in Capital Reporting, Planning and Financial Analysis. 
• Business Partnership
• Be a strong business partner to Operations function heads, learn and help navigate the business using finance metrics, results and KPIs as tools.
• Support site team governance structure with standing membership of SMART, IMPACT, JMT teams.
• Drive continuous improvement and risk mitigation projects in partnership with functional leaders.
• Financial Management & Controls
• Perform month-end close activities, including monthly production activity, cost allocations and reconciliation of inventory balances. Identify, investigate, and resolve potential issues within tight time constraints. 
• Manage and control expense and capital transactions through the corporate accounting system (SAP BW) including maintaining and reconciling accrual transactions. 
• Communicate effectively with internal finance departments, including Vendor Finance, R&D Finance, Capital Finance, Corporate FP&A and others to ensure quick and accurate resolution to financial issues. 
• Support and direct Internal Control audits.
• Monitor compliance to corporate financial controls and code of ethics.

MAJOR SKILLS AND BEHAVIORS:

• Demonstrated analytical acumen and problem-solving skills. 
• Independent self-starter and proactive leader. Seeks to continually improve business processes and add value. 
• Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries.
• Commitment to customer service with a strong sense of ownership for projects and results. 
• Must be able to work in a fast-paced environment that often requires commitment of more than 40 hours week.
• Good business acumen and strategic thinking.
• Ability to work collaboratively as a team with business partners.
• Ability to stand in for Site Finance Head and  work with senior leadership team as needed.

...

The aim of this job is to support the global Business Process Owner / Head of CoE for the global Learning Solution to establish and maintain a global Learning Solution across the Roche organization, in particular in your area of responsibility. Located in South San Francisco, you provide consultation to the Business in the assigned regions and functions. You work with the local and functional Business Process Owners to ensure that the global processes and standards are embedded in the respective organizations.  In this position, you support the End-to-End Lead in identifying were process and system improvements are required and scope the   initiatives and projects. You are responsible for the delivery of assigned initiatives for your area and across the Roche world in collaboration with the CHRIS LSO servicing and support organizations.

The main responsibilities are:

• Stakeholder management and consultation to the business in the assigned regions and functions:
• North America  
• Latin America
• Middle America
• NAM and LATAM Commercial Operations
• Pharma Manufacturing (PT)
• Diagnostics Manufacturing
• Act as single point of contact for the business, functional and local BPOs
• Gather needs and areas for continuous improvement based on input from the Business,  and address those to the End-to-End Lead and global Business Process Owner / Head of CoE
• Balance local requirements for the assigned area with those of the global and group functions
• Execute the delivery of assigned initiatives (e.g. E2E) across all regions and functions in close collaboration with the CoE and business counterparts
• Liaise with the CHRIS LSO support and servicing organization on new requirements and on the delivery of initiatives
• Enforce the implementation of end-to-end processes locally and functionally (esp. where no dedicated local BPO exists)
• Provide input to global process documentation
• Support change management

...

The Analytics Manager/Sr. Manager participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues and to support strategic decision making for the company.  The Analytics Manager will utilize advanced analytical techniques to: 1) Increase understanding of effectiveness/ROI of all promotional efforts including sales force; 2) Mine and analyze longitudinal patient-level data to generate hypotheses for brand teams and to inform primary market research; and 3) Measure the impact of business unit and multi-product initiatives on product specific performance.  The Analytics Manager/Sr. Manager has a broad understanding of pharmaceutical data, including sales and claims data, and which source to leverage in order to answer business questions most effectively.  He/she works with MA&S and Brand team colleagues to understand business objectives and to apply analytics for marketing projects.  The Analytics Manager/Sr. Manager conducts critical analyses by integrating multiple data sources to provide an objective viewpoint and recommendations to the Commercial organization.  He/she utilizes SAS and advanced statistical techniques to:

 

MAJOR RESPONSIBILITIES:

1. Develop and implement standard ROI principles and analyses and present results to marketing teams (20%)
2. Develop and implement analyses for field force promotion, including customer segmentation, targeting, and promotional response measurements (20%)
3. Make recommendations to brands and other stakeholders on the effectiveness of different marketing tactics (10%)
4. Generalize approach to measuring common programs across the business unit (10%)
5. Establish and maintain data and approaches to measuring tactic interactions and cross-product impact (10%)
6. Partner effectively and collaborate with other MA&S colleagues to provide holistic analytical insight (10%)
7. Develop Marketing Mix models to optimize marketing spends. Create process for effective monitoring and decision making of marketing spends (10%)
8. Represent brand-specific MS approaches and customizations to the broader team to ensure consistency in MS across the portfolio; learn from others, and proactively share and seek out advice on approaches to complex MS situations (10%)

...

Ensure efficient and effective delivery of operational plans based on agreed IT processes, standards, regulations and tools. Improve existing and new processes and procedures to ensure that the Identity and Access Management service is performed in the most efficient way to support current and future business needs.

Primary Responsibilities

High Performance Organization:

• Focuses on process optimization and continuous improvement of existing Identity & Access Management processes and tools
• Follows established processes and standards in the execution of daily duties and job function

Adapts and deploys new technologies to Roche:

• Develops the Identity and Access Management services
• Promotes the Identity and Access Management services with all customers
• Supports the integration process of new or updated components by following established standards and providing the expected deliverables for handing over the service to operational teams and customers.

Drive continuous productivity improvements:

• Supports the integration of registration processes within the company’s identity management solution with focus on improving the operational environment, processes and procedures including data migration activities
• Follows appropriate SOPs and instructions required for the integration of registration services

Keep the business running:

• Manages the configuration and master data by assessing and specifying the possible need of data quality improvements
• Applies change management processes while managing the Identity & Access Management process integration
• Support the integration of business processes and applications by leveraging the Identity and Access Management infrastructure, tools and directories and following project management best practice.

Responsiblities unique to this job:

• Manages the analysis, design and handover of access registration processes to the operational teams
• Ensures proper documentation and training material regarding registration processes is in place and kept up-to-date
• Manages the identity and access management processes to meet OLAs/SLAs by adhering to regulatory and qualitative requirements
• Increase process efficiency and cost effectiveness while providing identity and access management services
• Manage the integration of registration processes with focus on improving the operational environment, processes and procedures
• Manages and maintains the registration process portfolio
• Monitors and verifies the effectiveness of registration processes through established KPI and trend analysis
• Contributes to audit processes
• Based on business needs, identifies and proposes innovative, integrated, economically viable solutions
• Integrate identity and access management processes by meeting SLA requirements
• Supports that all solutions, documentation and procedures are implemented and maintained in a fully qualified and current state as applicable
• Registration processes are clearly communicated and trained
• Continuously strives for increase the skill level and expertise in the corresponding area
• Keeps abreast of business needs by maintaining close relationship to service management and other support services teams.
• Ensures compliance to Roche and Informatics Standards for technology, monitoring and support tools, SOPs and policies
• Ensures that documentation is current and accurate, SOP’s are understood and adhered to and platforms operate in highly secure and qualified environments in compliance with Audit, Regulatory and Validation requirements
• Ensures SLA requirements are understood and the required processes are implemented and managed to support compliance
• Provides shared platform support services as agreed (SLA or other) with the SM functions and other service consumers
• Provides input to support service levels and costs
• Fosters a working environment that encourages team members to fully contribute to achieve Roche’s goals
• Actively provides feedback to customer and team seeking for process improvements and efficiency gains
• manages the different integration projects within the portfolio to integrate new/existing IM applications into the service
• ensure standardization and globalization of application registration services by improving the operational environment, processes and procedures
• interface with the corresponding Engineering team if new features/interfaces are required
• ensure proper testing of application registration integration
• handover of new productive application registration processes to the operational team(s)
• create metrics/key performance indicators and develop/apply ...

Senior Health Economist (E5)/ Principal Health Economist (E5A)

RESPONSIBILITIES INCLUDE:

-Design, develop, conduct and manage HEOR studies for assigned products and indications in the cardiometabolism or neuroscience therapeutic areas

-Develop, maintain and apply in-depth knowledge of role, including disease state and clinical topics, market/ customer landscape, and emerging issues.  

-Work independently with minimal guidance, direction and mentoring from manager and others to clarify directions and expand knowledge and skills

-Proactively collaboration with various functions including medical directors, commercial, managed care marketing, development and other gMed functions to ensure alignment of activities with key partners and stakeholders

-Develop HEOR strategy for the medical plan for pre-launch and/or post-marketed products.  

-Design and execute prospective and retrospective outcomes research studies, in collaboration with academic consultants and contract research organizations.  -Develop economic models and AMCP dossier chapter to support launch. Manage budgets, timelines and deliverables as planned.

-Lead and/or participate in HEOR and cross-functional projects. 

ABILITIES:

- Demonstrate strong leadership and communication skills; can contribute to the development of vision and strategy in Medical Affairs teams.

- Demonstrate abilities to manage complex responsibilities, to include integration across multiple projects and priorities

-Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrix project team environment

...

 Responsibilities:

This position is for a Principal Engineer/Principal Manufacturing Technical Specialist reporting to the Associate Director of Technology Validation in the South San Francisco Production Technology Department.  The candidate will independently lead highly complex compliance and transformational validation program projects.  The candidate will also be expected to lead site implementation of complex multi-site CAPAs and quality system deployments.  These projects require close collaboration with site Manufacturing, MSAT and Quality and other functions as well as network colleagues and corporate quality functions over the course of multiple years.  This candidate will sit on the Technology Validation Leadership Team and will assist the Associate Director in developing group goals and development plans.  The candidate must provide mentorship and direction to staff on interpretation of the Roche Quality System requirements, execution of the Qualification Lifecycle and Qualification Strategies for highly complex projects.  This candidate will also be responsible for representing Genentech in agency inspections and audits.  They will participate in network teams developing quality system approaches.

...

The PD Biometrics and Clinical Sciences Informatics (FPPO) team is looking for a highly skilled Delivery Service Manager, who will support the Biostatistics, EpiPRO, and Thesaurus 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 FPPO management and business clients

...

The Department is currently seeking an additional Pathologist to work with five of its Pathologists to help them support (i) research scientists who discover and develop drugs for the treatment of cancer, and (ii) research scientists and clinicians who discover and develop biomarkers for pharmacodynamics and patient selection purposes in Phase I, II and III clinical trials of oncology therapeutics.

The successful candidate will be familiar with, if not expert in, the molecular, cellular, systems biology, and pathogenic mechanisms of cancer. He/she will have a strong interest in providing pathology support for drug and biomarker discovery programs in cancer, and an appreciation for the need for potential flexibility in contributing support to programs outside of oncology as the need arises.  Depending on the candidate and the availability of resources, there may be an opportunity for the individual to spend part of his or her efforts in basic and/or translational research activities that have relevance to the company’s business goals.

...

As the Medical Director you willbe responsible for the design, implementation, monitoring, analysis, andreporting of studies conducted within the Late Development Oncologyorganization. You will also participate in developing the long-range strategicplans for the molecule or molecules within the area of Oncology.

 

Key Accountabilities:

Assisting in the overall management,planning, evaluation and documentation of projects and studies

Participation in on-going medicinedevelopment activities including:

•  Preparation of regulatory documentsand interaction with global regulatory authorities

•  Monitoring and reviewing incomingdata

•  Analysis, presentation andinterpenetration of on-going studies and published data

•  Interactions with health authoritiesand expert bodies

•  Close collaboration with drugsafety, regulatory affairs, medical affairs and clinical trial operations

•  Participation in the preparation ofabstracts, posters and presentations for scientific meetings and congresses

•  Developing and writing clinical plansand protocols ensuring that they are scientifically sound

 

To be successful in this role, youwill have the following skills and experience:

•  Solid experience in medical research includingwriting clinical study reports and interpreting clinical data

•  Good communication and collaborativeskills with experience at working with cross-functional and external groups,including researchers, clinicians and other stakeholders.

•  Proven track record of delivery ofexperimental or novel studies

Confidence at presenting at internaland external strategy meetings

...

All candidates are welcome to apply, but a preferred candidate has been identified.

The Senior/Principal Health Economist is part of the broader Oncology Medical Unit organization and provides health economics and outcomes research, modeling, reporting, and other relevant analyses, within applicable legal and regulatory guidelines, which can be used to quantify the value of Genentech products in economic or societal terms. 

The Senior/Principal Health Economist will work with multiple products and indications within the Oncology portfolio and will support cross-functional Genentech and Roche teams by recommending, developing/conducting and advising on HEOR research and modeling strategies, and by developing medical and payer value propositions, portions of product dossiers, and other scientifically-based communications. 

This team supports strategic decision-making for late-stage development and across the product lifecycle. The Senior/Principal Health Economist helps set Genentech HEOR strategies, direction, objectives, and plans for innovative, effective and efficient execution. 

The Senior/Principal Health Economist will be fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. As a manager and coach of others, the AD/PHE is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, s/he leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. The Senior/Principal Health Economist monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. ¿

Responsibilities:

Incumbents are generally expected to:

• Functional lead for HEOR activities for the molecules and indications assigned, including participation in design and conduct of studies as needed

• Set and manage to outside spend budgets for multiple projects and products, including assuring that direct reports meet budget commitments and develop financial management skills

• Manage one or more health economists or other HEOR staff, with less than half of his/her time devoted to management

• Including hiring, development and ensuring technical excellence

• Directly engaged in designing, developing and conducting HEOR studies with strategic impact for the molecules for which she/he is responsible

• Maintain strong, positive relationships with senior internal stakeholders across Genentech and Roche 

• Lead development of the vision, strategic and tactical plans, resource and budget plans, for the products and indications under his/her responsibility.  Includes establishing annual and longer-range plans, goals and objectives, and effectively aligning these with Genentech and Roche cross-functional research, development and commercial strategies and objectives.

• Lead and manage execution to ensure work is completed on-time, on-target and within-budget, with the highest levels of accuracy and relevance, and in consistent compliance with legal and regulatory guidelines, Genentech and Roche policies & procedures:

• Working collaboratively, effectively and efficiently with all internal and external customers, partners, stakeholders and influencers

• Develop and cultivate relationships with key KOLs (Key Opinion Leaders) and other thought leaders, to support HEOR strategies, plans and objectives and provide strategic, critical influence for Genentech's product pipeline and portfolio

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies.

• Utilize only approved resources and messages to meet goals and targets

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