Provide statistical and strategic support related to clinical development plans, study designs, planning and execution of exploratory biomarker analysis, and incorporation of biomarker objectives in clinical development plans.

Major Responsibilities and Accountabilities:

• As part of a clinical development team, collaborates in the preparation and review of protocol writing, CRF design and monitoring of ongoing clinical trials.
• Provides technical and strategic support into clinical development plans
• For assigned clinical development project(s), provides statistically sound clinical trials design, including clinical pharmacology trials and data analysis input to meet project objectives.
• Supports teams in the development and review of regulatory submissions such as clinical protocols, INDs and pre-meeting packages.
• Provides strategic and analytical support for exploratory project activities such as biomarkers and PK/PD analysis
• Develops statistical analysis plans, including biomarker analysis plans, prepares data displays and as necessary develops statistical programs to perform exploratory analyses.
• Authors the clinical study report; with help from senior statistical staff, leads team members to complete the report.
• Provides advice and training on the use of statistical methods and software packages to the biomarker scientists
• Collaborates with scientists in support of external publications.
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

This position may be filled at an Audit & Analytics Manager, Contract Services or a Senior Audit & Analytics Manager, Contract Services

Audit/Senior Audit & Analytics Managers play a leadership role in assuring Contract Operations full and consistent compliance with business, legal and regulatory requirements that govern contract services and customer partners for all commercial and relevant government programs and contracts. Audit & Analytics Managers perform internal audits and manage external contracted customer and 340B entity audits. In addition, Audit & Analytics Managers gather, analyze, synthesize and provide partners and stakeholders with compliance and audit related-data to support ongoing business operations and decisions, which includes identifying and interpreting trends that emerge from internal and external audits and communicating these findings and implications to partners/stakeholders. Given the nature of their work, Audit & Analytics Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. The audit responsibilities of this position are critical to ensuring the integrity, accuracy and compliance of Contract Operations processes and activities and external contracted customer compliance. Senior Audit & Analytics Managers are expected to play a leadership role in guiding overall compliance operations and practices across Contract Operations. As such, Senior Audit & Analytics Managers may have one or more direct reports and they also share some of the other departmental management activities with their manager, e.g., reviewing the work of others, representing Contract Operations compliance to cross-functional teams, partners and stakeholders, preparing and delivering senior management presentations on strategic or complex issues, and leading strategic projects.

• Acts as a lead SME for Contract Operations and customer audit compliance and SOPs
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current Contract Operations systems, processes and practices. Develops appropriate responses, including recommending changes to general and/or auditing and analytics practices to assure Contract Operations’ ongoing compliance and accuracy
• Plays a lead role in development, implementation and ongoing maintenance of Contract Operations SOPs
• Develops, recommends, implements and educates others on performance metrics for Contract Operations general and audit-specific practices
• Oversees and ensures timely and targeted development and delivery of Contract Operations Compliance & Analytics training; including conducting training for other staff members and, as appropriate, others outside of the department
• Leads other project initiatives
• Serves as the primary point-of-contact for SPCM Contract Operations’ compliance and auditing. Includes all compliance-related initiatives and representing Contract Operations’ and customer compliance and audit activities to internal and external partners and stakeholders
• Serves as an expert on all applicable laws, regulations, corporate and business unit standards and requirements and helps drive cross-functional operations to assure compliance, accuracy and achievement of all other key performance metrics for Contract Operations
• Works with other audit managers and internal process SMEs to ensure proper process controls are in place
• Oversees or otherwise supports internal and external audits by organizing, compiling and storing necessary data and creating reports and presentation materials
• Oversees and conducts timely and targeted internal auditing and validation to ensure compliance, as per Contract Operations SOPs and other business, legal and regulatory requirements
• Partners with 340B field account management teams to provide auditing, analysis, reporting and communication support for 340B Program Integrity
• Provides expert post-auditing guidance and advice to cross-functional partners and stakeholders and, where applicable, plays a lead role working with SMEs to identify root cause and develop process-driven solutions and corrective action plans
• Where applicable, closely monitors corrective action plan implementation to assure timely, thorough and compliant follow-through
• Oversees or otherwise performs analyses and provides reporting to identify trends and interpret data related to Contract Operations and customer compliance and auditing activities 
• Plays the lead role in presenting audit and corresponding analytical findings, insights and recommendations to stake...

Supervisor

• Manages the daily workflow, ensuring adequate coverage is available
  on a daily basis
• Performs ongoing analysis of existing operations and implements new functions and tactics as required
• Identifies trends/obstacles for distributor/vendor relationships and
  reimbursement activities
• Keeps current with applicable laws, regulations and policies that
  govern the conduct of activities and ensures staff members are
  adhering to these guidelines
• Maintains timely and effective communications with management
  regarding departmental issues
• Investigates and responds to customer complaints while concurrently
  instituting necessary improvements to avoid recurrence
• Ensures accountability for project timelines and SMART goals
• Provides staff with clear expectations, consistent direction, coaching and feedback
• Provides first line of support for escalated calls and external
  customer support issues
• Provides managerial support internally and externally
• Sets performance standards and conducts staff performance evaluations
• Identifies and communicates vision and strategy to team
• Identifies internal and external training requirements
• Works with internal business partners/stakeholders to understand
  their strategies and goals for integration into departmental goals and
  objectives
• Works with Planning Ops as appropriate to develop departmental budgets
• Creates, disseminates and directly manages special projects, audits
  and reports for team
• Identifies and undertakes a variety of special projects aimed at
  increasing effectiveness and finding efficiencies; also participates
  on cross-functional teams that help further operational success
• This position may require some travel and flexibility in work shift

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.

Sr. Strategy Manager

The Sr. Strategy Manager, Strategic Pricing & Contracting develops pricing and contract strategies for the assigned segments that optimize the value of Genentech’s portfolio, which includes leading cross-functional segment strategy development teams, building effective relationships with account core teams, internal teams across MCCO (Managed Care & Customer Operations), scenario analysis/modeling for overall financial and legal viability, and ongoing pricing and contract performance assessment/analysis.

This opening would be primarily focused on leading launch preparations for octreolin, a recently in-licensed compound for the treatment of acromegaly. Acromegaly is a disease affecting 20,000 people in the US. This is a long-term condition in which there is too much growth hormone present resulting in body tissues enlarging over time, ultimately leading to various co-morbidities and a shorter lifespan. We are excited about this opportunity for Genentech as we feel that octreolin could represent a significant advance for patients with this devastating condition. The potential launch timing is Q1, 2015.

This supervisor role would oversee the Growth Franchise (Nutropin and Octreolin) and will have one or more direct reports and will also share some of the other departmental management activities with their manager, e.g., reviewing the work of other managers, developing training/development programs and initiatives for team members, preparing and delivering senior management presentations on strategic or complex issues, leading strategic projects, etc. Given the nature of this group’s work, most management and staff in this department have considerable responsibilities for regular communications, interactions, coordination and development with partners in the broader Roche organization, and communicating with, influencing, and securing approval from senior management.

• Typically manages pricing activities and contract strategy performance analysis for more complex, high-volume or high strategic value products
  • Participates in various Genentech business planning meetings and processes
• Regularly leads strategic pricing & contracting analysis and assessment for the assigned segments, franchises and products across all stages of the lifecycle
• Acts as segment subject matter expert for assigned account segments
• Works closely with Account core teams to devise appropriate strategy for decision-making, terms and negotiation.  Executes all needed analytics to influence MCCO Governance or related field leadership teams on winning strategies
• Stays abreast of macro trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Conducts or commissions market research and competitive analysis working with other internal or external partners as necessary
• Develops detailed quantitative and qualitative analyses and modeling of pricing and contracting strategies and recommendations
• Synthesizes market and business analytics in presentations and communications
•  Works with brand pricing and contracting strategy leads to align brand or overall segment strategy with account-based needs
•  Tracks and communicates all relevant pricing and contracting trends and issues in assigned segments to internal partners/stakeholders
•  Prepares internal reports and presentations and reviews with key internal partners/stakeholders; has frequent presentations to senior management
•  Identifies and recommends metrics to assess pricing and contracting strategy effectiveness for all assigned segments
•  Tracks and monitors account performance, including post-hoc analysis of account level strategy and implementation results
•  Works closely and collaboratively with a host of internal partners/stakeholders including, but not limited to operations departments to understand operational considerations and constraints related to strategies and representing this input to the core teams
•  Recommends on contract group clustering to ensure appropriate consistencies as well as provide maximum leverage, efficiencies, and effectiveness
•  May support manager in building pricing and contracting models and other tools for department-wide analysis and assessment
• Translates research, analysis and modeling into documented pricing and contracting strategies.  Works with manager to ensure integrated cross-segment consistencies and efficiencies
• Evaluates immediate-, medium- and longer-range business and financial impacts of pricing and contracting strategies
• Identifies and supports others in planning for operational and tactical requirements to support pricing and contracting strategies for existing, new, in-line and/or pipeline stage products
• Partic...

The Sr. Finance Manager plays a pivotal role providing financial support for Global Biologics Technical Operations (PTB).  The Biologics Operations manufactures over 70% of worldwide Pharma revenue and is the primary supplier of clinical production.

This position reports to the Head of Finance – FMTB Financial Planning & Analysis and Accounting and supports the financial planning and analysis of 11 manufacturing sites in 9 locations and $2.5B of spending. 

This is a high-profile, global role that interfaces with senior management and cross-functional finance teams such as Supply Chain, Quality and Operations.  

Specific Responsibilities:

• Support forecast, budget and long range planning process for PTB, coordinating with finance teams across US, Singapore and Europe.  Produce executive updates and analyses.
• Provide support to local Genentech manufacturing finance functions in planning activities, such as financial systems interface (TM1) and process management.
• Partner with global finance teams to explain underlying business drivers on variances and alert management on risks and opportunities. 
• Consolidate, analyze and communicate financial performance for global Biologics.
• Collaborate with financial systems team to improve financial models, processes and analyses.
• Business partner with several leaders on forecasting and reporting their cost center budgets. 

Data Management Manager / Sr. Manager

Data Management Manager / Sr. Managers act as subject matter experts and lead contacts for Commercial Operations’ Customer Master Data. The Master Data Management function and team are responsible for development and management of all Commercial Operations’ Customer Master Data operations and projects, including analyzing and matching master data with customer data, reconciling and validating data, systems or database upgrades and ongoing management, attending to ad hoc data requests, and leading and/or participating in special data projects that impact Commercial Operations’ Customer Master Data. Like other Data Management teams, Master Data Management works closely with a host of internal partners, including Genentech’s Commercial Operations Informatics (gCOI), as well as external data or IT vendors/consultants. Data Management Manager / Sr. Managers are typically assigned the largest or most complex projects or other operations to support and they may also people management responsibilities for one or more direct reports. Incumbents in the Data Management Manager / Sr. Manager role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities. As a manager of others, the Data Management Manager / Sr. Manager is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.

Incumbents in the Data Management Manager / Sr. Manager role are generally expected to:

• Act as lead subject matter expert for Commercial Operations' Master Data Management operations and projects. Including leading and/or otherwise supporting the largest and/or most complex projects or other operations: 

• Identifying new business rules to support best-in-class customer master data
• Expertly leading data analysis, extraction, matching, reconciliation and validation activities with the highest possible levels of accuracy and timeliness
• Consistently complying with all Genentech IT protocols, procedures, standards and other relevant business requirements
• Expertly fulfilling other ad hoc requests and leading special data projects, which includes upgrading and launching new systems or upgrades
• At all times, ensuring all work is completed on-time and on-target to fully meet or exceed expectations, goals and targets
• Developing and maintaining excellent working relationships with customers, partners and other stakeholders; providing the highest quality customer service and following established departmental protocols, policies and procedures

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies
• Manage the overall relationship with master data vendors
• Utilize only approved resources and messages to meet goals and targets
• Where assigned, recruit, hire, and develop direct reports, as well as oversee their work to ensure assigned goals, objectives and targets will be met or exceeded
• Effectively and efficiently train end-users and/or other customers, partners or stakeholders on Commercial Operations’ Customer Master Data operations, content, usage, applications and the like
• Support his/her manager and other team members in training and mentoring less experienced analysts
• Participate, as and when needed or otherwise appropriate, in cross-functional or other project teams; helping the overall business of Genentech to continuously evolve, improve and excel

Responsible for producinginnovative biotherapeutic medicine by interfacing with highly automatedproduction systems and controls in cGMP manufacturing environment, and maintainareas in high state of inspection preparedness. Operates production equipment for cell culture or purification that mayinclude culture growth, process monitoring, sampling, harvesting, purification,formulation, freeze thaw and transfer.  Performsmedia/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatoryrequirements utilizing current Good Manufacturing Practices (cGMP) and StandardOperating Procedures (SOP).  Responsible for being proficient in two or morefunctional areas and applies expert knowledge of mechanical, scientificprinciples, processes and biopharmaceutical processing equipment.

• Provide coaching and training on best practices and compliance toSOPs.
• Prepare solutions for the production process.
• Participatein continuous operational improvement.
• Providereports to management summarizing goal unit attainment.
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• Understandsthe theory, concepts, and regulations behind biopharm technology andprocesses. 
• Astrong knowledge of at least one manufacturing department with an understandingof process impact of other areas.
• Anticipatespotential problems and takes preventative action.
• Requiresjudgment to know when it is necessary to consult with supervisor and/or supportgroups. 
• Understandshow own actions impact others and uses this information in decision-making.
• Operate systems that clean and sterilizetanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check allcalculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and processproblems.
• Comply with safety requirements, cGMP,SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a teamenvironment.
• Exhibit professional interpersonal skills. 
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• All employees with jobs that require access to theWarehouse must be able to pass the Transportation Security Administration (TSA)Security Threat Assessment (STA).
• Follows established safety and environmentalguidelines and procedures for all work performed.  Immediately reports safety and environmentalincidents including injuries, illnesses, near misses, and safetysuggestions.  Fosters a positive safetyculture in which no one gets hurt.
• Operate fermenters, centrifuges, otherharvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operatingcleaning, set up, and maintaining 20L batch reefed fermenters; inoculating andmaintaining spinner seed cultures using aseptic techniques, maintaining cellbanks; and performing general seed lab operations.
• Perform CIP and SIP. 

Project Manager – IT (Genentech – South San Francisco)

The MCCO Solutions team in IT Americas is looking for a motivated Project Manager to lead the delivery of technology projects in support of US Commercial Operations. The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of the project management methodology. The PM will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This PM position will be accountable for projects in the MCCO Solutions group for the Commercial Customer Operations portfolio.

Duties:

* Define, plan, and lead the execution of technical implementation projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Ensure project objectives/requirements are clear and agreed to by all stakeholders

* Manage relationships with various technology vendors/partners and business stakeholders to achieve project objectives

* Establish and maintain effective communication for assigned projects and with dependent projects

* Ensure successful and timely completion of deliverables

* Track progress against baseline schedule

* Plan, baseline and control costs to ensure projects are completed within approved budget

* Suggest process improvements where appropriate to improve operational efficiencies

* Conduct risk management planning, identification, analysis and monitoring on projects

* Other duties as assigned

• Lead and/or participate in tech transfers of purification processes across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities.  Requires close collaboration with cross-functional team to implement, validate, and license Drug Substance processes at receiving sites.
• Responsible for providing on-going technical support for Drug Substance production at contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement.
• Lead and/or participate in global initiatives and cross-functional teams in the areas of downstream processing.
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process design and operations to ensure consistency and compliance across the biologics manufacturing network.
• Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
• Provide technical leadership for topics including support for proposed manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
• Travel within the Roche network and to contract manufacturing sites will be required.

Position

Pharmacovigilance Programmer Analyst

Job Summary/Purpose:

Experienced Oracleprogrammer with good knowledge of Drug Safety databases.

• Assumes responsibility for the analysis of data from the Drug Safety Database (ARISg DataMart).
• Develops, tests, documents, maintains and validates programs written in SQL, PL/SQL and SAS.

Primary Job responsibilities:

The positionis within the Data Management Group (DMG). DMG is responsible for dataretrievals from the Drug Safety database. These retrievals are performed on adatabase named "ARISg DataMart", a databases that gets dailyincremental uploads from the ARISg transactional system. The DataMart isdesigned and optimized for data retrieval.

The maincustomers of DMG are the members of safety Science located in Basel,Switzerland, and San Francisco, CA. DMG performs data retrievals for ad-hocquery requests, aggregate reports and for signal detection. Currently all DMGmembers are located in Basel, Switzerland. The position is created to supportSafety Science on site in San Francisco.

Thefunctional requirements in detail are the following:

• Interactswith internal or external customers to clearly define the search criteriarelating to requests; and to aid in the selection of the appropriate dataanalysis strategy and adequate presentation of results.
• Checksresults of database retrievals for consistency and plausibility. Initiatesappropriate actions in case data inconsistencies are detected.
• Performs thestatistical analysis and presents data in appropriate format i.e., reports,line listings, tabulations or graphs through using a variety of tools like SQL,SAS, Excel.
• Ensurestimely and correct delivery of search results.
• Responsiblefor the documentation of the search strategy and the results (electronically oras hard copies). Ensures search strategies and results of searches are filedand archived.
• Assists inout-of-normal-office-hours ad hoc/special database searches in the event ofurgent enquiries or audits by regulatory authorities.
• Assumesresponsibility for signing validation documentation.
• Ensures anyissues relating to database searches are highlighted to the Head of PDS DataManagement Group.

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Senior Finance Manager 

JOB DESCRIPTION:

Position is dedicated to supporting the financial management of the South San Francisco Production Business Unit (BU). The position will report to the Associate Director of Finance for South San Francisco Production and is part of the Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization.

MAJOR RESPONSIBLITIES

Responsible for the financial planning, analysis, and reporting activities of the South San Francisco Drug Product Manufacturing operation. Act as point of contact between the operating group and the finance organization. 

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.
• Actively participate in development of new business systems and metrics, working with the Technical Operations Finance and Corporate Accounting organizations as necessary to define and implement. 

Planning and Analysis

• Work with operations teams to provide input on the development and tracking of appropriate metrics and goals for planning horizon. 
• Lead business partners in the execution of planning exercises (forecasts, budgets, long-range plans): 
• Coordinate efforts of business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and all deadlines are met. 
• Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate. 
• Provide support for all presentations and submissions. 
• Identify and execute opportunities to improve operational results. Partner with Business Unit management to achieve targeted costs and continuously improve.
• Analyze spending and cost of production monthly and provide direction to BU management using SAP. 
• Develop financial decision frameworks for operational issues and lead analysis through final recommendation. 

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 BU 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. 

MAJOR SKILLS TRAITS:

• Demonstrated analytical acumen and problem-solving skills.
• Independent self-starter and proactive leader. Seeks to continually improve business processes. 
• Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries (within a manufacturing environment desired). 
• 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.

Responsibilities:

Works with senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. As part of a clinical assessment team, collaborates in the preparation and review of clinical assessments. For assigned clinical development project(s), provides statistically sound experimental design and data analysis input to meet project objectives and Health Authority's statistical requirements. Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations. Develops study analysis plans as a team member; lead this effort for selected studies. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, and verify data accuracy and validity. Co-author efficacy analysis results in the clinical study report. Supplies statistical input for filing submissions and in response to FDA questions. Provides support for publications. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

Job Purpose:  

The Head, Safety Sciences, leads and directs one of the therapeutic areas of safety science aligned with the Oncology disease to provide strategic direction and standardization of performance across the Safety Science groups.  

The Head, Safety Sciences directs Product Development Safety's (PDS) disease area specific scientific analysis including medical evaluation, risk assessment and management, signal prediction/detection, Comparative Benefit Risk, using epidemiology and other input as appropriate.  

The Head, Safety Sciences will ensure the incorporation of Comparative Benefit-Risk concepts in the disease area strategy and product plans and their use throughout the development and commercial lifecycle of products assigned to the cluster to ensure their longevity. In general, he/she is a member of a Development Review Committee (DRC).

Primary Responsibilities:

• Ensure proactive surveillance and monitoring activities across theirsafety science cluster to ensure that Roche is aware of potential emergingsafety issues and has developed strategies & action plans to prevent &mitigate risks.

• Direct and manage the SSLs andtheir teams within the safety science therapeutic area and provide guidance tothe relevant development and safety committees as appropriate.

• Maintain managerial oversight ofissues and outputs from the therapeutic area Safety Teams address or elevateissues to the PDS Global Head, Drug Safety Committee, Lifecycle Teams, Research and Early Development teams, and various committees.

• Ensure the incorporation of ComparativeBenefit-Risk concepts & qualitative/quantitative methods in the DiseaseArea (in collaboration with Clinical, Regulatory & Medical Affairs) andtheir use throughout the development and commercial lifecycle to ensure thesafety and longevity of all products in their therapeutic area.

• Leadcontinuous improvement efforts in Safety Science capability and performancetogether with the other Heads of Safety Science areas. Provide leadership and linemanagement to their reports and other members of the Safety Sciences departmentacross multiple locations. 

• Build andleverage Roche and PDS’ influence with internal and external entities to createvalue for Roche.

• Ensure Collaborative and constructive business relationships with majorpartners where applicable (with particular interest in Chugai).  Ensure particular emphasis is placed oncommunication flow and inter company.

• Contributes as part of the Global Leadership Team to the overallmanagement of the Safety Risk Management Department.

• Partners with Clinical Development organization to facilitate and collaborate towards the development of new oncology products proactively. Build strategic relationships with Clinical Development Oncology to drive innovative trial designs and influence decision-making.

The Jr. Programmer Analyst position will be responsible for providing production support for one or more Managed Care and Customer Operations (MCCO) business application solutions (such as the Contract Administration & Reporting System, Government Price Reporting, Validata, eWorkflow, and Channel & Inventory Management systems).

Duties:

• Provides operational support for Managed Care and Customer Operations business applications, including ticket monitoring, troubleshooting, and deployments
• Diagnoses and resolves user-reported issues within established Service Level Agreement timeframes
• Assists other Programmer Analysts with projects and maintenance & enhancement (M&E) releases as needed
• Consults business users to identify current operating procedures and deliver against business and system objectives
• Monitors and troubleshoot application performance issues
• Maintains system support documentation 
• Drives to complete assigned tasks and demonstrates accountability by contributing to the completion of milestones associated with specific projects.
• Acts as an effective team participant and collaborates on team direction and decisions
• Performs other duties as assigned