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.

Job Purpose:

The IT Business Systems Analyst (BSA) position in the Patient & Physician Solutions team will be responsible for the delivery of technology capabilities for the Access Solutions organization in the US, which provides services to help people access Genentech medicines for a range serious conditions. The IT BSA will work on multiple projects for both internally-facing case management tools and externally facing web-based solutions serving physicians and patients, and will be accountable for understanding the needs of customers, developing effective user-friendly designs to meet those needs, and delivering detailed requirements and specifications to drive the development, testing, deployment and production support of IT systems.  

Primary Responsibilities:

The IT Business System Analyst (BSA) will drive the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path.   The IT BSA will assist in determining which methodology path will be most likely to ensure a successful delivery.  The BSA will be responsible for building deep understanding of processes used by medical practices and internal case managers to serve patients, and for integrating the knowledge into the design and delivery of tools to serve all users.  The IT BSA will establish themselves as a “thought partner” with internal customers.   The IT BSA will assure smooth integration with key partners leading the development, testing, training, communication and deployment of technology across the country, keeping management apprised of developments through clear and timely communication.  

Specific responsibilities include: 

• Collaborate with Project Managers, Architects, Engineers, Developers, User Experience Designers and Software Quality Assurance on scope, solutions, constraints, and risks 
• Analyze/document current and future business process models 
• Analyze/document high-level requirements (scope) 
• Analyze/document detailed functional requirements and business rules (use cases) 
• Analyze/document data requirements (from business needs perspective) 
• Support planning of user acceptance test (UAT), including creation of UAT scripts 
• Perform knowledge transfer to training and communication teams and support user deployment activities as needed
• Lead business stakeholders and other business systems analysts thru the business analysis lifecycle

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

EXAMPLE DUTIES AND RESPONSIBILITIES:

Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate

Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices

Provides regulatory expertise and leadership to site and regional cross-functional teams and other groups

Stays abreast of therapeutic area product development and other related business strategies and plans 

Serves as the primary PDR representative on one or more regional projects at any one point in time

Analyzes data, the regulatory environment and business objectives to recommend priorities

Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche

Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development

Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment

Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project

Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management

Serves as the site and/or regional principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site and/or regional teams

Provides internal teams with direction on regulatory authority interactions

Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources

Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made

Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 

Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions ...

Senior Business Systems Analyst 

The Senior Business Systems Analyst will be responsible for supporting Strategic Pricing and Contracting Management (SPCM) systems planning and business process support, including contract development, contract administration and government price reporting operations. This role supports alignment of business processes and systems to provide accurate business monitoring, analytics and operational excellence across SPCM Teams.

The Senior Business Systems Analyst will be responsible for providing leadership on system projects including data analysis, user requirement gathering and documentation, business process documentation, and impact and gap analysis. They will serve as the subject matter expert for contract development, contract administration and government price reporting business processes, and the Veritas applications.

The Senior Business Systems Analyst will need to develop an understanding of the complex data environment in order to enhance standard reports, perform analysis and develop ad hoc queries and reports. This position requires the ability to retrieve data from multiple environments, identify trends, perform analysis and make recommendations. They may also lead or participate in developing data management strategies (including MCCO IT initiatives such as with the Channel, Customer and Contracting Performance, C3PI Initiative) and implementing accurate infrastructure for robust and hight-accuracy analytics. The position also requires strong written and verbal communication skills and an ability to collaborate with management and other functional groups within the Commercial organization. The data analysis will also support the SPCM Operational Excellence program that will be driven by existing and new metrics.

This position will be expected to have an up-to-date knowledge of the enterprise IT strategic direction and be able to influence IT system decisions that will be cost-effective, supportable and scalable. This will require strong leadership on projects and in the prioritization of the overall project portfolio, developing business cases and driving to maximize sIT ROI. This position reports to the Group Manager, Strategic Pricing and Contract Process and Technology.

Dept: Biological Assays, Method Management and Technology, PTQBP

Job Category: Quality
Location: SSF

Department: MMTech (Method Management and Technology)
Description: Senior Scientist Bioassay

Summary

The Biological Assay Function within Genentech’s Global Quality Organization is responsible for life-cycle management and innovation of post-BLA biological potency methods and specifications. We serve as the scientific and technical Center of Excellence for biological assays and analytical ELISAs within Commercial Quality for the Roche/Genentech Global Quality Network. We are looking for an experienced Senior Scientist to take on a leadership role and to play an integral part in the function.

 
Requirements

Candidates must have in-depth experience in the development of cell-based potency assays and immunoassays in an industrial setting. Understanding of mechanism-of-action of antibody-based protein therapeutics is essential. Broad experience with a variety of biological in-vitro systems is required. Familiarity with antibody effector function determination and enzymatic assays would be an asset. Prior experience in assay validation/ qualification and technology transfer are highly desirable, as is GMP experience and a strong sense for compliance. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Working knowledge of statistical approaches will be helpful. Must be highly motivated and comfortable working independently in a fast-paced environment. Experience with regulatory submissions (IND/BLA) and Health Authority interactions will be advantageous. Management experience of direct reports is expected.

• The successful candidatewill be responsible for the design, development and implementation of delivery devicesfor parenteral pharmaceutical therapeutics.  Primary technologies in-scope of the role includemanual injection systems, automated injection systems, and interfaces withpre-filled syringes and cartridges.
• Major responsibilitieswill include the development and commercialization of devices includinginterfaces with the primary container.
• This person will be atechnical expert and will provide technical leadership in the development andcommercialization of new drug-device combination products in collaboration withRoche and Genentech's engineering, scientific, and manufacturing organizations.
• He/she will provideguidance and input regarding product development and will regularly interfacewith staff and leaders in Commercial Marketing, Clinical Sciences, ContractManufacturing, Product Core Teams, Pharmaceutical Development, PackagingDevelopment, Quality and Regulatory Affairs.
• He/she will also regularlyinteract with external development partners and component suppliers, and may alsosupervise staff members.

The Records and Technology Manager will focus on electronic records management.  The purpose of this position is to supplement the Corporate Records department at Genentech that develops policy and consults on information issues, provides some operational support, and develops and delivers training on records management topics.  We expect close collaboration with the Genentech team, and with Roche global partners and stakeholders.

The Records and Technology manager will be responsible for developing strategies to apply records management principles to both structured and unstructured electronically stored information throughout its lifecycle.  The candidate needs to be knowledgeable about records management principles and have a deep understanding of systems that enable people to create, use, find, and share information such as document management systems, databases, collaboration applications, archive platforms, email systems, and cloud computing.  The candidate will be knowledgeable about emerging technologies and be able to identify records management concerns.  Some timely topics include system decommissions, email management, retention and lifecycle management of data in collaborative systems, application of retention periods to electronic records, and recommended formats and other issues related to long term preservation of electronic records.  The candidate who assumes this role will also oversee the staff managing the offsite storage services and application. 

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

A post-doctoral research fellow position isavailable in the Late Stage Pharmaceutical Development group to investigate thetemperature and concentration dependence of protein interactions in solutionand cryogenic conditions. Many monoclonal antibody (MAb) products are developedas high concentration solutions, and have been observed to present a range ofissues (aggregation, precipitation, phase separation) on storage. Thetemperature dependence of intermolecular interactions between proteins andother solution components remains poorly understood, in particular in cyro-concentratedconditions. The objective of the post-doctoral research fellow will be to characterizethe temperature dependent interactions of antibodies in both liquid and frozen glassystates, using a variety of biophysical techniques and novel experimentalapproaches to gain understanding of the underlying molecular basis of theprotein and solvent interactions that result in a variety of bulk solutionbehaviors.

The candidate will be a member of the Analytical Chemistry group in the Method Management and Technology (MMTech) Function within Genentech’s Corporate Quality Organization.  MMTech is the scientific and technical Center of Excellence for commercial quality control methods, specifications/control systems and reference standard and provides support to the Roche/Genentech Global Quality Control Network for the commercial biotech product portfolio. We are looking for an experienced Scientist to play an integral part in providing and supporting analytical chemistry methods (e.g. HPLC, CE) used for quality control purposes.

MAIN PURPOSE OF THE POSITION

• Responsible for method troubleshooting and optimization in support of life-cycle management of methods for Roche/Genentech commercial biotech products
• Develop and execute experiments for the development, validation, implementation of QC test methods for commercial biologic products following cGMP regulations, regulatory guidelines as well as local and global quality standards.
• Support regulatory submission and inspections: through authorship of CMC subsections, responses to questions and direct interactions

JOB DUTIES/RESPONSIBILITIES

• Serve as analytical technical lead/representative (biotech products) on cross-functional and multi-site project teams.
• Ensure on-time delivery of controlled documents, reports and method packages to support project timelines.
• Apply technical knowledge, scientific experience and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of departmental functions.
• Perform assigned tasks and work to achieve company goals and department objectives.
• Train personnel and internal customers on relevant business processes.
• Support the development and administration of Quality Control and laboratory training materials.

The Senior Corporate or Corporate Counsel will work as part of the Healthcare Law Group within Genentech's Legal department. 

The position will initially focus on counseling Genentech’s commercial sales and marketing clients, with opportunities to advise medical affairs and development across the lifecycle of products. The position may require counseling medical affairs and development teams with human medicines and companion diagnostics in all phases of development.  

 JOB/POSITION SCOPE:  

•  Manage outside counsel on complex or more advanced matters or projects 
•   Responsible for one or more key client relationships typically at Director level or   higher 
•  May be single point of contact or represent practice group or functional area on significant projects or committees 
• Provide advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
•  Assist in structuring tactics and related contracts in compliance with applicable law;   
•  Serve as lead legal counsel for global development programs and medical affairs initiatives
• Negotiate agreements with cooperative groups, government entities, study sites, and other parties involved in global studies; and
• Draft and interpret  company policies, and educating clients and colleagues about enforcement trends and discrete legal issues.   
• Act as a subject matter expert on all matters relating to healthcare law and related business operations 
•  Act as a standing or ad hoc member of business or leadership teams and provides legal counsel and expertise into business decisions 
•  Develop an in-depth understanding of assigned departments and functions in terms of their, organizational structure, processes, business goals, strategies and challenges, etc. 
•  Provide  legal advice in matters relating to healthcare law, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of products 
• Provide  input and legal advice on business strategy, tactical plan development and implementation, and other business issues; including legal assessments, solutions-oriented risk mitigation strategies, messaging, and interactions with healthcare professionals, patients and other external parties 
•  Participate  in, lead  and/or present  to various Company committees or other advisory, project or work teams and provides healthcare and business law expertise and guidance 
•  Review  business materials (clinical trials, brand plans, promotions, medical plans, publications, training documents, etc.) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics 
•  Provide  transactional support to assigned internal clients. May include drafting, negotiating, and/or reviewing contracts, creating, updating and training on contract templates, negotiating language, developing associated legal/contractual documentation and/or policies & procedures, and counseling on contract disputes   
•  Interact and communicate with Roche affiliates and global partners, as appropriate, to apprise them of relevant Company policies, procedures, practices, important business issues, etc. and share best practices or coordinate legal support 

 PEOPLE MANAGEMENT: 

• May manage administrative personnel 
• Where applicable, lead recruitment, hiring and on-boarding for direct report positions 
• Accountable for direct reports' work to ensure on-time, on-target and within-budget results 
• Ensure direct report(s) are appropriately trained, developed and coached 
• Responsible for performance management of direct report(s)

DEVELOP & MAINTAIN  KNOWLEDGE 

• Stay abreast of evolving healthcare and related legislation and regulations and the enforcement landscape. Advises the Company and colleagues of potential implications to current or future strategies and operations and assures ongoing compliance 
• Develop and implements training to educate internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal c...

Summary of Position:

The Clinical Safety Associate I (CSA I) assists in the clinical processing of adverse event (AE) information received by US Pharmacovigilance (USPV).  Responsibilities are performed under the direction of the USPV Manager. 

Job Duties/Responsibilities:

• Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
• Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
• Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
• Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
• Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
• Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
• Participates on Study Management Teams (as applicable)
• Assists in the development of drug safety presentation for investigator meeting presentations.
• Assists in clinical trial reconciliation process (as applicable).
• Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
• Ensures departmental workflow processes and timelines are followed. 

Competencies Identified for Success:

• Works effectively as a team member and promotes collaboration
• Demonstrates initiative and accountability
• Strong organizational skills, detail oriented, ability to adapt to change
• Confident decision maker

The successful candidate will be a key member of the Cross-Portfolio Analysis & Communications (CPAC) team within PPP/Pharma Portfolio Management. The CPAC team provides management with late stage and cross-portfolio information that enables a shared understanding of the portfolio, and robust analytics that offer unique insights on Roche’s direction, strategic alternatives, and ultimately contribute to effective corporate decision-making.

Responsibilities:

• Representative responsibilities associated with the role are detailed below:
• Develop analytics around portfolio spend, future portfolio projections and “what if” scenarios
• Assess Roche’s performance versus competitors across various R&D-related metrics
• Provide guidance to, and participate in, cross-functional initiatives on R&D productivity, cost and valuation metrics, and long-range planning
• Participate in preparation of quarterly reports for senior management on progress of portfolio and implications

Job Skills and Expectations

• A strong understanding of pharmaceutical/biotech industry, drug development trends, and business strategy
• Financial acumen and understanding of commercial and development forecasting methodologies
• The ability to analyze and draw conclusions out of large, complex data sets and articulate the key findings to management and functional leaders
• Strong oral and written communication skills
• Innovative mindset and comfort with ambiguity
• The ability to build cross-functional partnerships and engage in (and at time lead) cross-functional initiatives
• A desire to make a difference and commitment and drive to see things through

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned

The job responsibility within the ADQC--Biological Technologies Testing Group is to perform cell-based and immunochemical/biological assays in support of process development, stability, and lot release testing with established procedures in a GMP environment.  Role includes reviewing assay packets and releasing assay data as well as prepare assay reagents, generate computer results, monitor assay quality, use of LIMS, maintain the lab via Lean tools such as 5S and EHS safety practices.  Expectations include lab maintenance and project support/equipment qualification/computer systems/document management as needed.