Level - E3/E4

Main Purpose of the Position:    
·         Solve a wide range of difficult Manufacturing Quality Assurance and Product Release issues that impact multiple functions following cGMP regulations and Genentech standards 
·         Perform assigned tasks and work to achieve company goals and department objectives.
 
Job Duties/Responsibilities: ·         Follow company policies and procedures.
·         Maintain a state of inspection readiness.
·         Provide input to the development of personal performance goals and departmental objectives.
·         Collaborate with Management to establish and meet targets and timelines.
·         Support routine operations and allocate assigned resources.
·         Manage competing priorities.
·         Serve as the Quality representative on cross-functional and multi-site teams.
·         Identify, design, and implement process and system improvements.
·         Lead and participate in the design and implementation of department and cross-functional initiatives.
·         Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
·         Serve as a technical subject matter expert (SME) in support of department functions.
·         Train personnel and internal customers on relevant business processes.
·         Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
·         Perform any other tasks as requested by Management to support Quality oversight activities.
 

Technical Duties/Responsibilities:
·         Manage the product disposition program in support of manufacturing operations.
·         Review and approve master batch production records.
·         Collaborate with departments to ensure product release activities are executed efficiently and effectively.
·         Review and approve lot release documentation.
·         Provide technical assessment for process changes that may impact product disposition.
·         Provide Quality oversight to internal and external customers.
·         Provide input into investigations with potential product, process, or material impact.
·         Ensure process and documentation discrepancies are identified, defined and assessed.
·         Recommend final product disposition impacted by a deviation or discrepancy to Senior Management.
·         Create and maintain a system for tracking, trending, and reporting discrepancies identified and assessed by MQA.
·         Develop a system for tracking, trending, and reporting product release cycle times.
·         Monitor MQA activities to evaluate trends, and report repetitive anomalies, observations, and discrepancies to Senior Management. 
·         Represent MQA at cross-functional meetings to develop, review, and approve Commercial Quality documents.
·         Participate in the MQA review audit program and the Raw Material Reconciliation process.
·         Present and provide rationale for the batch release program during periodic audits and regulatory inspections.
·         Prepare, review, and approve relevant sections of regulatory submissions.
·  &nb...

• Acts as lead of market planning team and primary contact for Market Planning projects and customers
• Supports strategic decision making across assigned areas/responsibilities; helping internal partners/stakeholders to maximize their commercial success
• Proactively evaluates/assesses the relevant market landscape, monitoring changes in market dynamics, competition, clinician and patient practices and needs, as well as other related factors
• Acts as a thought partner and consultant to assigned teams, functions and other relevant partners/stakeholders
• Partners with brand directors and other stakeholders to review and contribute to lifecycle, brand and tactical plans and provide supportive insights to help further inform, shape and influence business strategies and plans
• Provides long-range business plan forecasts for assigned brands
• Where appropriate, may partner with others, to review and integrate product- and market-specific assessments, analyses and the like into portfolio-wide (across all Genentech therapeutic areas and/or beyond) assessments for executive level reviews and decision-making
• Where assigned, helps internal partners/stakeholder to identify and set key performance metrics for assigned brands
• Employs a wide range of market analysis efforts and techniques, including penetration assessments, market share analyses, product concept testing, etc.
• Provides the continuous, in-depth cumulative perspective on the relevant market(s) and brand(s)
• Acts as the expert on the customer landscape, providing in-depth information and insights into customer practices and needs. As such, also possesses and applies in-depth product and therapeutic area knowledge
• Uses his/her understanding of the "broader market" to link insights and recommendations to wider strategic issues, challenges and/or opportunities:
• Synthesizes relevant analyses and prior research findings to develop a cumulative perspective of the relevant market(s) and associated factors; translates such into clear and meaningful implications for communication and review by internal partners and other stakeholders
• Recommends research/analysis methods and matches these to project objectives; understanding potential and/or limitations of various sources and methodologies
• Draws substantive conclusions from results; identifying implications, challenges or other opportunities and delineating clear next steps
• Develops a "command" of data/info sources and a sensitivity to biases
• Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Defines questions and required data; appropriately comprehends quantitative methods and analysis techniques
• Identifies themes across projects and information sources; performing appropriate, aligned and integrated "meta-analyses"
• Where assigned, tracks key performance metrics for assigned brands
• Where assigned, creates, validates and refines forecasts for in-line products, new indications and new market opportunities. Presents updates on revenue information to senior management
• Where applicable, hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

• Acts as lead contact for patient insights projects and ongoing consulting regarding the assigned franchises and brands
• Provides an objective commercial viewpoint, based on an in-depth understanding and analysis of patient dynamics and trends as these relate to the assigned franchises and brands: 

• Proactively and continuously monitors the external landscape, as it relates to assigned franchises/brands and existing or potential patient populations. Identifies, assesses and communicates patient trends (e.g., access, reimbursement, personalized healthcare needs, etc.)
• Acts as a thought partner and consultant to all relevant teams, functions and stakeholders
• Works closely with team members in Market Planning, other groups in Market Analysis & Strategy, Franchise Marketing, Patient Marketing, eMarketing and others to identify and plan for patient and related research programs and studies. Identifies, and/or participates in the identification of, critical opportunities for growth, and helps to ensure key patient insights are embedded in the strategic direction of Genentech's current and future businesses
• Participates in the identification of strategic issues or questions to be answered by research projects and/or through leverage of existing analyses and information.  Helps shape and structure patient and related market research programs and studies.  Participates in the definition of questions and required data. Works with his/her manager to identify themes across projects and information sources
• Performs regular and ad hoc patient and related market research, analysis and scenario modeling using primary research from commissioned studies and/or secondary research and analytics. Regular analysis may include patient segmentation, market share analysis and assessment, etc. Employs various analytical methodologies and techniques; and demonstrates understanding of potential and/or limitations of data sources and analytical methodologies. Develops a "command" of data and information sources and a sensitivity to biases.  Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Synthesizes data and identifies implications of patient and related influences relevant to Genentech's current and future business. (Where applicable, performs "meta-analyses" across projects and information sources where similar themes or opportunities may exist.) Draws substantive conclusions from results; identifying implications, challenges or other opportunities, and delineating clear next steps
• Provides internal business partners and stakeholders with a cumulative set of recommendations on patient strategies, plans and tactics (includes risk assessment and mitigation, new business opportunities, line extensions and the like)

• Provides strategic and operational patient insights and recommendations to support various Genentech business planning processes, e.g. long-range Business Plans, 3-year brand and 1-year tactical plans
• Acts as an industry expert on patient research and the general patient landscape, providing ongoing in-depth information and insights to internal partners and stakeholders
• Regularly communicates key patient and related market information to various teams and individuals throughout Genentech
• Complies with all laws, regulation...

Specific opportunities available in the following areas:  Personalize Healthcare & Companion Diagnostics; Commercial Assessments; Health Information and Technology (HIT) & Industry Intelligence; Managed Markets Analytics

Industry Analytics participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues related to access, reimbursement, and managed care influence.  Leveraging strong structured problem solving skills and collaborating with partners in Market Analysis & Strategy (MA&S), Managed Care & Customer Operations (MCCO), Government Affairs (GA), and Commercial brand teams, the Industry Analytics (IA) team translates market phenomena into unbiased, astute, and actionable insights, and creates innovative analytical solutions in support of key business objectives and decisions.   

• Provide an objective commercial viewpoint based on in-depth understanding, analysis, and synthesis of qualitative and quantitative primary and secondary information.  Assess the market impact of policy, regulatory, and development trends affecting GNE’s portfolio, including current or emerging trends.
• Navigate a complex internal set of teams and functional groups addressing the future landscape and impact, and have an appreciation for the nuanced role that Industry Analytics plays in this effort.
• Navigate a high degree of uncertainty while effectively communicating a point of view and best estimate for planning purposes.   Comfort with ambiguity and can act without having the total picture; able to effectively pose questions in order to "tease out" information required for decision-making.
• Collaborate with Market Planning, Brand Teams, Government Affairs, Medical Affairs, Regulatory, Legal and Global partners in order to inform and model assumptions, communicate impact, influence risk mitigation strategies, and support company initiatives and messaging on strategy.
  
• Successfully identify appropriate opportunities to employ secondary and primary market research techniques to accomplish the above. Guide and conduct primary market research as needed to inform key assumptions critical to good decision-making.  Have sound knowledge of the strengths and limitations of secondary data.
• Successfully employ structured problem solving and quantitative modeling techniques as required to inform key business questions.

• Technical Skills: Actively Provide Strategic Support to Relevant Partners [relevant partners – see above description].

• Conducting Analyses & Scope and Structure Key Environmental Driver Business Questions. With some support and guidance from manager, assumes full accountability for asking questions of partner experts to seek deeper understanding of real drivers of decision-making and to identify core business questions. With some support from manager, appropriately scope and structure projects, establishing a framework, key deliverables, and milestones in alignment with key stakeholders. Demonstrate ability to break complex problems down into distinct parts, simplify complexity, and manage uncertainty.
• Deriving Insights.  With some support and guidance from manager provide strategic insights and recommendations to brand by linking learnings across projects. Assess appropriate use of primary and secondary research, leveraging internal expertise and resources as appropriate.
• Presenting Results.  Presents objective insights from analyses to relevant partners up to and including CLC.
• Level of Expertise.  Is knowledgeable in a variety of structured problem solving frameworks, market research methodologies, and excel forecasting techniques, and can apply them across business questions. Develops relationships and collaborates with relevant cross-functional partners to deliver respective subject matter expertise (see above job description) to teams, acting as point person in MAS&S for respective area.

• Collaboration: 

• POD Collaboration: Collaborate with MA&S Partner Groups to deliver a synergistic analysis to provide an integrated perspective.  With some guidance of manager, leverages expertise of POD to provide an aligned analytical viewpoint, adhering to team mission, objectives and norms outlined in POD guide
• Leads Cross-Functional and Complex Project Teams With some manager support, customizes the collaborative pod approach to address complex cross-functional business questions.  Delivers the Industry Analytics value proposition to partners.

• Resource Management and Planning:  Manages contracts and budgets for assigned projects independently.  Align with manager and partners on project expectations and delivers on them with manager support.  With manager guidance, prioritize and plan workload and identify capacity issues proactively.
• Managing Up: Effectively applies judgment to leverage and inform manager in navigating organization and completing work

Product Manager / Senior Product Manager

The Product Manager, Lytics Cathflo Marketing reports directly to the Group Product Manager and is responsible for:

Management of all peer-to-peer Cathflo programs including speaker's bureau, Cathflo Nurse Trainers, Cathflo Nurse Liaisons and national webinars.
Development of relevant medical education content and patient case studies for inclusion in peer-to-peer programs. Evaluation of nurse thought leader engagement strategy in partnership with the field and other internal partners.
Evaluating new means of marketing broadly to nurses, with a goal of driving an increase in habitual CVAD line assessment. Planning and execution of annual advisory boards in support of Cathflo, as needed. Contribution to the development and execution of the 3-year brand plan, and the 1 year tactical plan for Cathflo.

The successful candidate must have:

• Proven strategic agility in a complex marketplace
• Demonstrated experience in the development and execution of a sales or marketing plan
• Proven ability to partner effectively with field sales and sales leadership
• Considerable skill in influencing without authority
• Ability to provide rationale-based, succinct and persuasive oral & written communications
• Working knowledge of product development, regulatory and clinical affairs
• Demonstrated ability to establish thought leader and other relevant stakeholder relationships
• Strong analytical and project management skills, including previous experience working with budgets and analyzing market research results

Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager

The Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager manages and further enhances the S&OP process for the Commercial organization. This individual plays a key role in ensuring continuous supply of products to patients by collaborating with the Supply Chain organization to ensure supply and demand alignment, and to balance financial, manufacturing capacity, risk, and other considerations. The individual in this role will establish and maintain key partnerships across US Commercial, and Global and North America Supply Chain organizations.

Primary Responsibilities:

• Manage monthly S&OP forecasting process to ensure base case and upside demand forecasts are comprehensive, accurate and representative of the most appropriate demand plan in achieving Genentech business goals
• Prepare executive level presentations including demand analysis and scenarios to facilitate discussions and drive Executive Sales and Operations Committee (eSOP) decisions

• Develop metrics and collaborate with brand Forecast Managers to improve forecast accuracy
• Consolidate and submit demand forecasts for all SKUs of in-line and pipeline Genentech products to  the Supply Chain organization
• Prepare standard portfolio reports to provide insights to sales performance for Commercial senior executives
• Actively participate in various cross-portfolio initiatives including tools and system enhancements to support forecasting processes and reporting

Overview:

The Sales Operations Manager role is to support the assigned business unit or franchise with regular and ad hoc business analysis and reporting of, for example, product sales, market share, market segmentation, reimbursement analysis, and/or other measures of business performance. They work closely with other team members in Sales Operations & Information Management, helping to ensure data quality, accuracy, timely and targeted reporting, optimized database and other information systems operations, which may include regular responsibilities to support ongoing operational management of the sales force automation/customer relationship management systems and processes. They also provide the assigned group with support in customer targeting, field workforce sizing, structuring and territory alignments, sales goal modeling and allocation, sales incentive compensation plan design, and/or payment distributions and administration. Given the nature of this role, they work regularly with cross-functional customers in the

assigned business unit or functional unit, such as Franchise Sales and Marketing, as well as a host of other internal partners and stakeholders, including Market Analysis & Strategy, gCOI (Genentech's Corporate Office of Information Technology), and others.

Key Responsibilities

• Primarily responsible for managing and training on all sales operations deliverables including operations launch planning, analytics, reporting, targeting, alignments, Incentive Compensation and Sales Force Automation for their assigned brand(s)
• Partner with sales management and Field Sales Operations to define and produce analytics that support the business objectives and strategies. Provide periodic reports and detailed analysis to identify drivers behind trends and potential business opportunities
• Develop communication materials to support field sales management on business reviews and sales force tools
• Support and respond to field sales inquiries around data
• Collaborate in the management of all IC operation activities including goal allocation, goal adjustments, IC reports. Partner with Compensation Administration team to validate and process incentive payouts, assess and provide impact on issues affecting field incentive plan
• Collaborate with the Information Technology team to define business requirements and solutions for all tools and deliverables that support the field sales force
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

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

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.

Brand Protection is a proactive initiative to protect patient safety, supply chain integrity and brand reputation by identifying and acting on individuals or entities that intend to mislead healthcare practitioners, caregivers, patients, trade organizations or the public at large for their own illegal gain.    

The Senior Manager, Brand Protection reports directly to the Director, Interactive Marketing and is responsible for overseeing the Brand Protection Core Team, managing key external partnerships, directing ongoing surveillance, executing the communication strategies, analyzing the impact of these entities and reporting initiative progress to Commercial leadership.

MAJOR RESPONSIBILITIES:

• Direct online and offline monitoring of suspect products, diversion, trademark infringement, and promotional abuse in the US market, maintain expert familiarity with core industry trends, including customer, competitive and enforcement dynamics in order to adapt and support various aspects of Brand Protection.
• Serve as the single point of contact for orchestrating Brand Protection activities across the Commercial organization.
• Leads a multidisciplinary, cross-functional Brand Protection Core Team that includes Quality, Trade, Security, Commercial Law, Patent Counsel and Customer Operations. 
• Leads the development of a communication plan that keeps both the CLC and the Commercial organization at large appropriately informed of Brand Protection initiatives and progress reports.
• Track online pharmacies selling Genentech products illegally and analyze behaviors relative to Rx requirements, trademark/copyright infringements, product format/packaging and pricing.
• Execute monthly communication strategies (warning letters) and track response to key actions.
• Prioritize monthly targets for suspect product purchase, secure senior management approvals, and oversee the purchase process. 
• Build and manage relationships with key Federal Enforcement Agencies  (FDA OCI, ICE, DOJ) and partner organizations (NABP, PSI, CDC).
• Develop and manage budgets/resource requests for all Brand Protection activities. 
• Serves as a member of the Counterfeit Core Team.

CAPABILITIES:

• Strong leadership presence with proven ability to influence stakeholders at various levels of the organization (both US and Global); capacity to work collaboratively with peers in pharmaceutical industry and engage support/ alignment.
• Ability to build, lead, motivate and represent matrix, cross-functional teams without direct reporting authority.  
• Superior verbal/ written communication abilities with demonstrated success at communicating complex situations and action plans in a simple, structured and easily absorbed manner.
• Willing to champion new ideas or positions to meet key goals and doesn’t abdicate responsibilities.  Can negotiate skillfully in tough situations with both internal and external; U.S. and Global groups.  Is comfortable around, and influential with, higher management.
• Experience in forecasting and building predictive models to understand impact of diversion on legitimate trade channels.
• Basic understanding of online promotional practices, search engine marketing and social media environments.  Understands consumer behavior and response dynamics.
• Strong commitment to patient safety and compliance requirements.  Maintain thorough understanding of U.S. compliance requirements and legitimate channel definitions.

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

RESPONSIBILITIES:

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