Overview

PDG (Product Development Global Clinical Operations) Learning provides strategically aligned learning and development solutions to the business functions across Product Development Global Clinical Operations (PDG).  This individual will drive the digital learning strategy across PDG and work to enhance PDG’s capabilities to better meet or exceed our strategic, business, financial and operational goals and targets in the areas of clinical trial planning and execution to fulfill our shared mission of:

 

Transforming molecules to medicines

Through the Rigorous execution of clinical trials

For the benefit of patients

The Head, Digital Learning reports into the Global Head of PDG Learning and as a member of the PDG Learning Leadership Team will have a responsibility to contribute to the longer-term vision, mission, and infrastructure for PDG Learning overall. 

Key Accountabilities

This role will be primarily accountable for consistently and effectively:

• Build and deliver on a digital learning strategy, and tactical plan to enable PDG Learning to drive functions and teams increase their skills, abilities, and knowledge and as a result have a direct impact on improvements in PDG’s business, strategies, operations, and goals
  
   

• Support PDG’s vision and mission through the development and delivery of digital learning solutions to promote the highest level of alignment, effectiveness, and efficiency across the organization including HQ sites and affiliates
  
   

• Collaborate with Learning Strategists and Learning Solutions to translate business needs and demands into the appropriate implementation and execution of solutions. They will also be responsible for partnering with IT, HR, and Quality teams on managing Cornerstone, our Learning Management System (LMS), ensuring appropriate measures to address compliance issues
  
   

• Leading the roadmap of current and future learning technology platforms, harnessing the use of learning technologies, measuring program impact, and ensuring alignment and mitigating compliance risk across PDG
  
   

• Implementation of learning technologies and lead governance around standardization and oversight to serve PDG learning needs, bringing a data-driven approach to decision making
  
   

• Ensuring the PDG Learning team meets or exceeds assigned goals and objectives

• Inspiring the PDG Learning team, recruiting, developing and retaining talent and ensuring a strong succession plan for key position.  

This individual is a strategic and creative thinker with strong program management skills and prides themself on being innovative and driving new ways of learning. They need to leverage empathy interviews, data and business insights to create compelling messaging that illustrates behavior shifts and employee development to stakeholders.

This role manages a team of direct reports.

Responsibilities

This position is responsible for:

 

• Leadership / People Management

  • Provide technology and digital learning strategic direction to PDG Learning

  • Lead, recruit, develop and retain talent on the team 

  • Create an environment that embodies a strong team spirit, timely and effective communications, sense of urgency and high motivation inspiring the team to achieve goals in both the immediate and longer-term

  • Develop roles/responsibilities,  resource requirements, immediate, medium and long-term capacity for the team
    
     

• Stakeholder Partnership

  • Builds and develops strong, sustainable relationships with all internal and external partners and stakeholders; working collaboratively with others to achieve common goals.

  • Works cross-functionally across PDG/PD, with other groups, Information Technology (IT) and other Roche partners, as well as external vendor partners supporting the work of Learning & Team Services, PDG or PD overall.
    
     

• Technology & Compliance Expertise

  • Drives knowledge of innovative and impactful technologies across other industries and how they may be leveraged within PDG / Roche

  • Participates in regular functional forums pertaining to the work of Training and/or the broader group (at all levels – site, global, etc.) to ensure consistencies, best practices and overall effective and efficient knowledge-sharing 

  • Management of Cornerstone LMS curricula strategy and partnership with local/global functions

  • Represent PDG Learning on PDQ learning councils related to GCP/GVP compliance training

  • Build learning metrics and analytics strategy that support PDG Learning organizational change

Qualifications, Experience and Expertise:

• Bachelor’ Degree is required  

• Advanced Degree in related field is desirable

• More than 8 years of relevant work experience is required, with a minimum of 4 years of experience in the biotechnology or pharmaceutical industries

• Advanced training professional certification is a plus 

• Experience with digital learning platforms and integration with learning management systems (preferably Cornerstone)

• Advanced experience in instructional design, development, delivery and measurement for adult learning with past experience in e-learning course development 

• Understanding of learning principles/methodologies and application in a complex business environment. Includes experience using a training design/development process, i.e., ADDIE or equivalent 

• Experience with E-Authoring tools and social media to drive engagement and sustainability.

• Exceptional people management and leadership skills. Demonstrated success leading a team of senior professionals and participating on leadership teams.

• Previous experience and/or exposure to and sufficient knowledge of clinical operations in the pharmaceutical/biotechnology or related industry 

• Must demonstrate knowledge of, and/or training in, regulatory and system compliance 

• Broad understanding of international regulations, processes and issues in drug development 

Job Summary:

The Senior Engineer/Technical Development Scientist leads and/or participates in teams responsible for conducting formulation and drug product process development for pipeline products. In addition to performing process characterization and formulation studies, this role will also focus on development of tools that will enhance efficiency and robustness of technical data packages. The Senior Engineer will operate in a matrixed environment and collaborate successfully with colleagues within Pharma Technical Development and cross-functionally to develop and operationalize study designs for process characterization.  He/She might also create and implement tools for data acquisition, analysis, and modelling.  This individual will work independently, leading projects and self-managing work packages with appropriate communication and escalation. The Senior Engineer will need to stay current on the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs. This position may require some travel to domestic and/or international sites.

Job Responsibilities:

• Lead and/or participate in teams responsible for conducting formulation and drug product process development for pipeline products 

• Plan, design, execute, and document laboratory studies related to drug product design, formulation development, and process development in support of pipeline products 

• Apply scientific/engineering principles and techniques, including modeling to develop, characterize and implement processes and to solve technical challenges

• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for investigations, corrective actions, change controls, process changes and improvements. 

• Author and review guideline documents and SOPs, technical protocols, reports, product impact assessments, and regulatory sections in support of Investigational New Drug (IND) and marketing application submissions. 

• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs. 

• Coordinate and organize resources needed to complete tasks. 

Job Requirements/Qualifications: 

•Bachelor's degree in related field required; Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline preferred

• 8+ years relevant work experience

• Experience in designing and implementing drug product unit operations such as freeze/thaw, formulation/mixing, filtration, filling, pre-filled syringe processing, lyophilization, capping, and visual inspection 

• Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers, statistical process control (SPC), and statistical design and analysis of experiments 

• Must have strong knowledge of biologics manufacturing, aseptic processing expertise and knowledge of cGMPs

• Strong skills in applying fundamental engineering and scientific principles to process design 

• Critical thinking, problem solving and independent research skills 

• Experience participating and/or leading cross functional drug product teams and/or multiple technical transfers of drug product processes

• Must have strong interpersonal skills and the ability to communicate and collaborate effectively with internal and external partners and peers 

• Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions 

• Project management skills, including the ability to manage multiple projects and evaluate project resource requirements (material, manpower, time, etc.) 

• Good organizational skills with strong attention to detail 

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#ptcareers

Job Summary:

The Demand Planner is the key interface between Global Supply Chain and the markets to build alignment of the sales plan & strategy with the production capabilities and supply plans.  The role also serves as replenishment coordinator to ensure continuous availability of finished goods at distribution centers.  It also serves as a strategic supply chain partner to functional counterparts to lead, create, or support deployment of supply chain strategies, organizational transformation initiatives, and system or process improvements.

This position plays an important role in the Global Supply Chain network by fulfilling the specific roles of the North America Demand Planner and US Replenishment Coordinator for a specific subset of products in the North America Region and by collaborating as a strategic supply chain leader and a mentor to other colleagues.  

Job Responsibilities:

Key Demand Planning Accountabilities:

•    Key interface between Global Supply Chain and the markets to build alignment of the sales plan & strategy with the production capabilities and supply plans.     

Collaborates with markets to drive demand integrity to ensure clear requirements for supply planning.Collaborate with Forecaster on product forecasting process management, identification and management of strategies to manage demand variability and forecast accuracy for a portfolio of high complexity and impact

•    Act as a Single Point of Contact for our customers (affiliates / direct markets / other) for relevant Demand Planning topics (Targets / Key Performance Indicators / Service Level Agreements) for a portfolio of high complexity and impact analyze the forecast, review forecasted quantities at consolidated level, check for imbalances and monitor alerts.

Accountable for the independent demand completeness and correctness for the appropriate horizon for a portfolio of high complexity and impact

•    Help articulate business exposure and communicate demand uncertainties and risks and develop options for optimizing Inventory, replenishment and demand plans to supply planning for a portfolio of high complexity

•    Responsible to present on status and issues on product supply for their respective market or region to the Sales & Operations Planning meeting

•    Lead, mentor, and influence colleagues on complex supply chain related topics that span across broad functional areas (e.g., Pharma Tech Ops and US Commercial organizations)

Key Replenishment Coordination Accountabilities:

•    Act as primary supply chain contact for MCCO, Brand teams etc., representing a specific subset of finished good products distributed in the US. The role will ensure that inventory is in place to support a continuous supply of finished goods to support US requirements.

•    Act as primary contact for the rest of the supply chain community on finished goods supply issues that occur within the frozen time horizon for a portfolio of high complexity and impact

•    Ensure appropriate levels of inventory are maintained the DC’s by managing/tracking SAP purchase orders, expediting, prioritizing lot disposition releases as appropriate and frequent communications with MCCO for a portfolio of high complexity and impact

•    Perform supply assessments and in depth scenario planning as needed in order to identify business risks, capacity risks, implementation timelines associated product changes, expiry risks, phase outs, launches, etc., and act as primary re-supply lead in case of supply shortages

•    Manage product life cycle events, including the leadership of US launch execution teams for new molecular entities or for line extensions and oversight of finished good item number changes in both the global and local SAP systems (switches).  May mentor other colleagues on product launches

•    Present supply chain topics in critical senior forums, such S&OP meetings or Global/Local expert groups, Field Action Committees, and participate in FDA calls if required.

•    Lead, mentor, and influence colleagues on complex replenishment situations related to critical supply situations, complex launch strategies, or scenario planning

Strategic Supply Chain Partnership Accountabilities:

•    Lead the innovation and deployment of supply chain transformation projects in line with global supply chain strategies, local/regional commercial priorities with impact that may extend beyond Pharma Tech Ops organization (PT).

•    Lead global/regional teams and affiliates to develop supply chain strategies, bringing innovation and integrated solutions to the network.

•    As a subject matter expert, lead and influence functional partners in system, process and organizational changes and improvements.

•    Innovate and lead implementation of improvement recommendations to improve and optimize the supply chain with broad regional, global, and cross division impact (e.g., across PT and US Commercial organization). 

 

Requirements/Qualifications:

- Minimum of 12+ years of related work experience, preferably with experience in in Supply Chain (Production Planning/Scheduling/Supply Chain Management)

- Prior experience in leading S&OP required and prior people management a plus BS degree in business or science related field required. APICS Certification preferred

- Good understanding of Pharmaceutical industry (drug development and regulatory environment) and Supply chain processes (Supply Planning, Material Requirements Planning, Capacity Planning, Order Management, Demand Planning, Data Management)

- Experience with forecasting, analytics, contemporary digital technologies a plus - Proven business acumen, strategic thinking, communication, change leadership, and influencing skills

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#ptcareers

PURPOSE OF JOB: Individual will be a member of an outstanding technical team and be the primary conduit for surgical technical information to and from the clinical environment including the operating room and clinic. Individual will be responsible for all aspects of Investigator and clinical staff training, certification and product device technical support to ensure optimal patient outcomes. Individual may contribute to clinical development programs on multiple levels as an integral member.

Key Accountabilities:

In this position, you will be primarily accountable to consistently and effectively:

• Provide master level device and surgical training, education and ongoing support to investigators and clinical staff on the use and application of company technology to the highest ethical and professional standards and in accordance with guidelines and direction.
• Work with company and clinical sites to support clinical trials involving Roche drug delivery device(s).
• Work with engineering, clinical and device teams to develop quality resources and knowledge assessment tools for the training of physicians and clinical support staff.
• Collect and internally communicate technical surgical information and feedback from clinical investigators.
• Continuously increase knowledge of new developments within the assigned market as well as company developments in order to function as a subject matter expert

Example Responsibilities: In this position, you could:

Operational activities:

• Attend implantation/refill/explanation of the surgical device, meaning you are present in the Operating Room and clinic to support and instruct the Investigator, operating and clinic staff.
• Provide remote and on-site support and training of surgical staff during the use of the device/system.
• Prepare and communicate to manager on a timely and regular basis:

Summary of field activities.

• Input on travel, budget and other resource requirements.
• Manage busy travel schedule and remote support capabilities
• Identify needs as they arise, propose solutions and complete special projects.

Strategy/Planning:

• Build and cultivate important working relationships:
  • Externally with assigned clinical sites and staff in order to support Phase I, II, III & IIIb studies
  • Internally, with cross-functional partners, such as Medical Science Liaisons, Product Development, Clinical Operations, Device Development, Research and Early

Development teams, or other Medical Affairs groups.

• Help to advance the development of Roche Drug Delivery Devices
  • As appropriate, advise on the design and development of clinical trials and investigations involving other Roche drug delivery device(s) to Evaluate, review and propose revisions to protocols in support of the development of the assigned drug delivery device(s).
  • Participates on cross-functional teams in the evaluation, field verification, implementation and enhancement of products
  • Utilize the learning’s and feedback from early Phase Trials to advise the development of technical support for later stage clinical trials and eventual commercialization.
  • Serve as the technical expert of site feasibility assessment for clinical trials involving Roche drug delivery device(s).

EDUCATION REQUIREMENTS:

• Bachelor’s Degree in a clinical/science concentration, education, communications, or equivalent combination of education and experience preferred

Required Experience/Knowledge/Skills:

• Five years experience in ophthalmic Surgical and/or clinical setting.
• Outstanding ability and desire to teach, demonstrated by possessing self confidence and effectiveness with a wide variety of student types
• Able to travel 70-80% of the time (may be 3-4 days/week within US)
• Be proficient in GCP (Good Clinical Practice), Adverse Event reporting and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
• Maintain all necessary certifications and hospital vendor credentialing including, but not limited to:
  • HIPAA Certification
  • Blood Bourne pathogen
  • Infection Control and Aseptic Technique
  • Fire Safety
  • Individual Institutional Requirements
• Able to interact professionally and effectively with customers, physicians, nurses and other medical staff
• Able to work independently from a remote environment
• Excellent attention to detail, possessing good organizational and time management skills
• Computer skills necessary to generate reports, presentations, spreadsheets, etc.
• Ability to communicate clearly and concisely in written and verbal communications
• Highly motivated and flexible team player with focus on the success of others.
• In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening).

The Individual Contributor in Market Analysis and Strategy (MA&S) is a strategic thought partner to key stakeholders and an integral contributor to Genentech’s commercial planning efforts.

He/she is responsible for providing strategic sales and marketing insights with minimal to moderate guidance / supervision, leveraging their capabilities in the following area of expertise:

• Marketing Science / Data Scientist: designing and delivering advanced quantitative data analyses leveraging large/complex datasets

The specific role of MA&S Portfolio Analytics Manager / Sr. Manager requires secondary data analytics capabilities. However, all Individual Contributors have the opportunity to blend and extend their expertise on different initiatives to further develop both the breadth and depth of their capabilities.

MAJOR RESPONSIBILITIES

• Work with Group Managers and Associate Directors to understand business needs and priorities, as well as immediate scope of work
• Provide technical/analytical expertise to team through secondary data analytics
• Apply analytical and statistical methods to answer a variety of business questions using multiple data sources and technical tools
• Monitor and assess the effectiveness of promotional efforts, projects, and practices and identify opportunities to optimize value of investments
• Support the identification and development of innovative programs and projects to enhance Genentech’s abilities to accurately target and measure the effectiveness and ROI of its market promotions
• Increase the sophistication and application of advanced analytics methods (including predictive modeling, machine learning, and scalable prototypes) to guide portfolio-level decisions efficiently and at the speed of business
• Act as subject matter expert for applicable advanced analytical methodologies, programs and projects
• Collaborate within cross-functional teams to develop solutions, gain alignment and deliver impactful business insights; engage necessary stakeholders to enable better decision-making
• Openly share perspective and insights to elevate team thinking and drive a balanced, holistic point of view; effectively weigh and communicate trade-off considerations
• Take an enterprise mindset, linking individual responsibilities with broader organization; focus on outcomes that provide most business value
• Demonstrate self-accountability
• Look for opportunities for continuous improvement; engage managers and peer group regularly for coaching, assistance, and advocacy
• Act as a thought partner and advisor to all relevant teams and stakeholders; look for and establish opportunities for peer mentorship

WHO YOU ARE

In Individual Contributors, we are looking for people who are nimble, able to effectively collaborate and lend expertise to multi-functional teams and adapt quickly to competing priorities. We are also looking for people who are committed to continuing to make Genentech a great place to work, by seeking opportunities to develop their own and others’ expertise through ongoing mentorship and coaching.

• "Self-starter"; strong sense of responsibility with demonstrable comfort in an entrepreneurial environment
• Able to work effectively in a fluid, cross-functional matrixed environment and stand out as a successful collaborator
• Strong interpersonal skills and a consultative mindset, with the ability to develop strong partnerships
• Good problem-solving ability, breaking down complex problems into distinct parts, managing uncertainty, understanding, anticipating interdependencies
• Able to proactively “connect the dots” by asking thought-provoking questions
• Objective when presenting insights and guiding decision-making; demonstrate good presentation skills by pairing sound analytics with storytelling
• Motivated to continuously improve performance; outcomes-focused and driven to achieve objectives
• Able to lean in and manage through change

PREFERRED QUALIFICATIONS

• Bachelor’s Degree (Business, Economics, Statistics, Mathematics, or Physical Sciences or related field); MBA or Graduate-level Degree
• 4+ years of work experience with Bachelors; 3+ year of work experience with Masters; 2+ years of work experience with PhD/JD, preferably within pharmaceutical or biotech industry (commercial or clinical) and/or management consulting
• Strong knowledge of the biotech market landscape
• Strong knowledge of secondary data sources including syndicated sales, promotional & marketing data, longitudinal patient level data; experience with payer data
• Considerable experience and expertise with statistical modeling, analysis and presentation of results to a non-technical audience
• Experience working with large complex data and corresponding query/ programming languages such as R, Python, or SQL plus experience with other big data technology such as Hadoop
• Experience with field force analytics, including customer segmentation, targeting, and promotional response measurements
• Experience acting as a strategic thought partner to teams; Demonstrated ability to problem solve and think outside the box
• Proven track record of leadership, time-management, project management, and teamwork
• Proven track record of flexibility and quickly adapting to new tools and situations
• Expertise in standard analysis and presentation software (Excel, PowerPoint)
• Persuasive written and verbal communication skills
• Strong attention to detail

 Job Description

The PDP Leadership Team Business Manager will be responsible for facilitating and coordinating a high-functioning PDP Leadership Team (PDP LT) to meet the rapidly evolving business needs around PHC.  In close partnership with PDP LT members, the Business Manager will help in building, maintaining, and continuously improving the PDP group by ensuring effective management of LT operations, as well as providing project management support for LT initiatives.

The Business Manager will help support LT efforts demonstrating its commitment to a One Roche approach, collaboration across the Group, development and growth of our people, as well as cultivating our technical expertise and excellence.  She/he will partner closely with other LT members to ensure alignment with key stakeholders in other functions to enable Roche’s PHC vision. The Business Manager will also be responsible for leadership communications and LT meetings, as well as PDP departmental meetings and global PDP offsites.  The PDP Business Manager will report into the Senior Vice President of PDP and be a member of the PDP Leadership Team. 

Responsibilities:

• Provides oversight and input to critical PDP LT initiatives, including those relating to group culture of sustainable innovation, people development, interfaces with other PHC groups, and participation in broader PD, Pharma, and Group initiatives
• Facilitates Leadership Team definition of appropriate success metrics and is responsible for tracking the metrics to measure success
• Partners with Business Operations Leadership to align on desired outcomes for R&D PHC implementation conduct and PDP functional operation.
• Manages the organization and conduct of leadership team and department-wide Town Hall/webcasts, management team meetings, offsites and other LT interactions
• Coordinates with peer PD Business Managers and Communications colleagues to assure alignment of messages coming from the LT
• Drives the rhythm/cadence of the work of the Leadership Team to align with corporate business process calendars (e.g., resource forecast, performance management), LT business plan, department metrics/scorecard, and team communications

Qualifications:

• The successful candidate will have the highest levels of integrity and trustworthiness, a broad business background, and a deep understanding of how Genentech/Roche works, especially in organizational planning and business management.
• The Business Manager must be able to participate in decision-making and information management with a very high level of discretion and confidentiality.
• Highly skilled and proven track record of accomplishing goals through influence and collaboration, working with cross-functional and multi-country team members.
• She/he needs to embrace the PDP philosophy of sustainable innovation and contribute to an environment where change, resourcefulness, and entrepreneurial spirit is celebrated.
• Strong knowledge of the biotechnology and pharmaceutical industries and project management skills preferred..
• Experience in Product Development preferred but not mandatory. Operations and Communications experience preferred.
• Demonstrated leadership, organization and communication skills
• Outstanding operational management skills, to include internal consulting, project management and highly effective teamwork and collaboration skills
• Ability to travel internationally and work on multi-cultural teams
• Bachelor's degree in life sciences or business, or equivalent work experience, with some experience in clinical and drug development preferred but not mandatory
• 2+ years work experience in a role with significant requirements for influencing high-performing teams
• 3+ years of work with multi-disciplinary experience, preferably in the pharmaceutical or biotech industry
• 3+ years work experience in project management; leading large-scale projects/programs, preferably in the pharmaceutical or biotech industry

Roche is an equal opportunity employer.

As an Senior Principal Data Scientist within our Personalized HealthCare function you will work with meaningful data to generate impactful evidence and insights on our molecules/medicines and patients, that support R&D, advance scientific and medical knowledge, and enable personalized patient care and access. As an Expert Data Scientist within the RWD Platform Applications Development group, you will use your skills as an experienced drug developer in the development and validation of the PHC platform applications and related tools for R&D applications, regulatory acceptance and clinical care, across therapeutic areas. The data will be varied in type -- patient-level clinical data, supplemented with deep patient data like omics (e.g. genomics, proteomic), imaging, digital health, etc. Source data will be diverse -- real-world data, including patient registries, electronic medical records, claims, biobanks, and clinical trials. You will also contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our business and healthcare environments.

You will need excellent strategic, leadership, collaboration and communication skills, as well as an entrepreneurial mindset, to work with and through others, to transform the way we use data and analytics to develop and deliver medicines for our patients and to achieve the business objectives. The position requires extensive cross functional collaborations working with a diverse team of clinical subject matter experts, data scientists, statisticians, and business leads to inform the research and development of our molecules, and support healthcare decisions by patients, physicians, health authorities, payers, and policy-makers.

Responsibilities:

• IDENTIFY EVIDENCE NEEDS & RECOMMEND DATA SOLUTIONS: Ask the right scientific questions, understand the evidence needs for research and development, regulatory and market access, and ideate and make recommendations on fit-for-purpose data and analytics solutions.
• DEVELOP DATA STRATEGY & GAIN ACCESS TO DATA: Develop strategic plans to access fit-for-purpose data sources to support evidence generation, and gain access to data through collaboration or data generation.
• DIVE INTO DATA: Develop a comprehensive and deep understanding of the data we work with and foster learning with colleagues using analytical tools and applications to broaden data accessibility and advance our proficiency/efficiency in understanding and using the data appropriately.
• BE AN EXPERT IN APPLYING METHODS: Stay current with and adopt emergent analytical methodologies, tools and applications to ensure fit-for-purpose and impactful approaches.
• PRODUCE HIGH QUALITY ANALYSES: Apply rigor in study design and analytical methods; plan for data processing; design a fit-for-purpose analysis plan, assess effective ways of presenting and delivering the results to maximize impact and interpretability; implement and/or oversee the study, including its reporting; ensure compliance with applicable pharma industry regulations and standards.
• INTERPRET AND SHARE RESULTS: Communicate findings to internal stakeholders, regulatory, health technology assessment (HTA) bodies and scientific communities; publish results; participate in external meetings and forums to present your insights (e.g. congress/conference).
• COLLABORATE & SHAPE: Collaborate and contribute to functional, cross-functional, enterprise-wide or external data science communities, networks, collaborative groups, initiatives on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, processes, etc. to enable broader and more effective use of data and analytics to advance science. 

Who You Are

• PhD in a quantitative data science discipline (e.g., statistics/biostatistics, epidemiology, bioinformatics, health economics, computational biology, computer science, mathematics, outcomes research, public health, biology, medicine, psychology) with a minimum of 6+ years of relevant work experience
• Demonstrated track record of developing and execution of data science research projects, patient-level data analyses (e.g., real world data, surveys, clinical trials, registries, claims, genomic or imaging data) with publications and presentations
• Demonstrated experience with managing project scope and driving delivery in an evolving environment requiring proactivity and effective problem-solving and prioritization when faced with challenges
• Demonstrated strong collaboration skills and excellent communication skills
• Demonstrated entrepreneurial mindset and self-direction, ability to teach others and willingness to learn new techniques
• Deep subject matter expertise with proven ability to transfer this expertise across the business; proven track record of setting new standards, advancing the field of expertise (internally and externally) and engaging & influencing executive leaders internally and externally (e.g. in academic setting).
• Experience in conducting observational research
• Expertise in clinical trials or in development of diagnostics or medical devices
• Proficiency in English, both written and verbal
• Preferred: Experience in regulatory submissions of molecules, diagnostics or medical devices
• Availability to travel up to 10% domestically and internationally
• Availability to work non-standard business hours regularly due to the global nature of role

#PDP

Relocation is not designated for this position.

Position Purpose:

• Provides operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs)
•  Ensures the timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Main Responsibilities and Accountabilities:

• Provides direction and leadership to one or more global Study Management Teams (SMTs)Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management. Builds and maintains effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables. Creates team culture and promotes team spirit. Develops and maintains effective working relationships with Study Management Team (SMT) members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams. In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members. Responsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work. Responsible for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies, across functions. Responsible for leading identification and selection of vendors; ensures appropriate cross-functional input into the scope of work
• Contributes to the development and management of the study timelines, budget, risk and quality plans. Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Global Studies Leader (GSL)Develops and manages clinical study budgets (including HQ budget). Communicates variances in the budget and action plan for resolution to the GSL.  Establishes study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections. Provides operational input into the development of protocol feasibility questionnaires
• Provides clinical operations expertise to ensure operational feasibility and delivery. Leads the development and finalization of site feasibility questionnaires. Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and Operational Program Leader (OPL)Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes. Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers
• Oversees forecasting of clinical/non-clinical supplies. Designs drug assumption and supply chain process in partnership with Drug Supplies, affiliates and GSL. Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study
• Delivers the operational elements of the study plan. Chairs operations team meeting and organizes investigator meetings, monitor training, CRO kick-off meetings. Ensures that reporting process of SUSARs is established and maintained for the duration of the study. Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with key stakeholders. Primary contact with affiliates to maintain oversight of performance, issues, their resolution and coordinates any corrective action.  Actively partner with Data Management and Clinical Science to oversee eCRF completion and data quality issues.  Ensures the completion and finalization of any corrective and preventative action plans resulting from site audits, in conjunction with CCO, etc., as necessary.  Oversees the maintenance of drug supplies and resolution of issues with input from the Drug Supplies.  Coordinates responses to study questions or issues from Health Authorities.  Provides operational input into the development and tracking of SMT goals
• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work.  Performs ongoing vendor management (e.g., CROs, Central Labs, IxRS, etc.), including negotiation of scope of work, budgets, performance management, and issue resolution.  Develops and supports appropriate site and CRO/vendor audit and quality plans
• Identifies areas of best practice and process improvements.  Participates in Product Development Global Operations initiatives and programs as assigned.  Maintains oversight and ensures consistency of the operational aspects across studies within a project
• Ensures study adherence to ICH/GCP and SOPs

Qualifications

• Life sciences degree or nursing equivalent.

Skills & Knowledge:

• Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock. Experience of project managing operational aspects of a clinical study including development and management of timelines and budgets. Good knowledge of ICH GCP.  Proven ability to successfully achieve results within a multi-cultural and geographically diverse team. Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.  Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization. Strong attention to detail.  Proficient computer skills
• Competencies Technical and Business Expertise Teamwork and Collaboration Communication Achieving Results
• Other Mobile: Some travel may be required

Roche is an equal opportunity employer.

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Position Purpose:

To prepare regulatory documents for submission to regulatory authorities within subject area (clinical/safety). Working with minimal guidance, the Senior Regulatory Documentation Scientist takes accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions. The Senior Regulatory Documentation Scientist applies scientific writing, document and project management expertise and contributes to the functional excellence of regulatory documentation through process management.

Major Responsibilities and Accountabilities:

• Manages the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
• Leads Writing/Editing Team for preparation of Clinical Dossiers/Safety Reports
• Reviews documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product/ within a clinical dossier
• Prepares specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
• Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing/Editing Team including work to be outsourced
• Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when required
• Acts as a mentor to new members/less experienced members of the Documentation group
• In addition, assumes the responsibilities of a Regulatory Documentation Scientist

Professional and Technical Requirements

Qualifications

• Bachelor’s degree or equivalent. 
• Advanced degree in life sciences or other relevant field preferred.
• 5+ years of regulatory and clinical safety report writing preferred.

Experience, Knowledge, Skills

• Demonstrated clear, high-quality scientific writing style in the English language
• Experience in regulatory affairs or related functions in drug development, knowledge of international regulations, and previous experience of authoring and/or editing regulatory documentation.
• Aptitude or proven ability to guide the work of others
• Ability to independently analyze and synthesize data from a broad range of disciplines
• Project management skills: consistently achieves multiple tasks and goals on-time
• Strong interpersonal and verbal communication skills
• Influencing skills: can influence without authority.
• Ability to work effectively in a team environment, establishes strong collaborative relationships, resolves conflict by creating an atmosphere of openness and trust
• Thinks through problems clearly and logically

Other:

Occasional overseas travel may be required.

The Regulatory Program Manager/Associate Regulatory Program Director position within the Technical Regulatory (PTR) organization will be responsible for developing and executing regulatory strategies and initiatives for combination products.

Primary responsibilities:

• Lead or support the development and implementation of global regulatory strategies for combination products and devices.

• Manage the preparation and submission of briefing packages and CMC sections of

IND/IMPD and BLA/NDA/MAA, including responses to questions from health authorities. Responsible for timely compilation of all necessary CMC documents to support technical contents of regulatory submissions.

• Serve as a combination product and device regulatory subject matter expert in

Roche/Genentech. Provide regular training internally to enhance organizational knowledge

and capability related to combination products and devices.

• Build strong collaborations and relationships with internal stakeholders to ensure successful

execution of regulatory submissions.

• Stay abreast of changing regulatory requirements relevant to combination products/devices. Analyze regulations, rules, or guidance documents and communicate potential impact to internal stakeholders.

Qualifications:

• Must have a scientific degree, an advanced degree desired.

• A minimum of 5 years of industry experience in regulatory, manufacturing, or quality related

field in the medical device and/or biopharmaceutical industry, including applicable experience with combination products or medical devices.

• Knowledge of ICH guidance documents and health authority regulations/standards relevant to

combination products or medical devices, specifically 21 CFR part 4, 21 CFR part 820, 21 CFR part 803, IEC 62633, ISO 13485, and EU Medical Device Regulation.

• Knowledge of software regulatory requirements and technical standards (IEC 62304).

• Regulatory experience of emergency use products is desirable.

• Excellent communication, collaboration, and interpersonal skills.

• Dynamic personality, ability to think outside the box and take smart risk.

• Ability to think “big picture” and focus on details.

• Effective problem solving and strong organizational skills, including ability to prioritize tasks.

• Drive for continuous improvements and operate with lean mindset.

10% international and domestic travel necessary.

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External Job Posting

States include TX, OK, NM, MO, KS, AR and NE

Position Overview: 

The Therapeutic Area Medical Science Liaison (TA MSL) is a credible scientific partner responsible for providing clinical and health economic information related to disease states and the appropriate utilization of Genentech medicines (approved and pipeline). This field-based position will engage with healthcare providers, population health decision makers, and patients within their region(s), to further patient outcomes aligned with the overarching objectives of Genentech. In collaboration with their regional partners, TA MSLs are accountable for co-creating the local medical strategy and delivering for their customers. In addition, TA MSLs may be responsible for covering multiple medicines, as well as engaging in broad scientific discussions around patient outcomes and total cost of care, resulting in rich customer insights shared with key stakeholders across the organization.

Key Responsibilities/Accountabilities: 

• Ensure an end to end customer experience for TA specific customers within the region
• Demonstrate deep scientific expertise about assigned molecules/products, franchise(s) and overall therapeutic area(s) to exchange relevant information and insights with top tier thought leaders and healthcare decision makers within a region
• Build, cultivate, and leverage relationships with key external scientific and medical customers and organizations in their region(s) to ensure strong understanding of evolving healthcare trends across the relevant therapeutic area landscape
• Demonstrate proficiency in topics beyond scientific exchange such as value / cost of care discussions, hospitalizations, risk of progression, drug pricing pressures, reimbursement education, and AE management
• Engage in continuous independent learning within the therapeutic area they represent and actively attend and participate in upskilling programs related to assigned molecules, products, disease states and relevant business topics
• Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures
• Build and cultivate important working relationships across field partners to ensure an enterprise approach when working with customers.  Be accountable to the regional team to shape and execute on local medical strategies within planned timelines
• Depending on regional needs and priorities, may be asked to serve in a Medical Affairs Executive Director (MED) role with specific customers
• Identify and bring insights back in house to Genentech stakeholders through efficient and effective use of CRM system
• Assist with Phase I - IV sponsored and supported clinical trials, health economic outcomes research, other TA specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance
• Share clinical and value-based expertise in the development and management of clinical and scientific communications for customers to include publications, conference data, and educational materials, as well as for internal Genentech communications and materials to be used in training and development activities
• Ensure assigned goals and objectives are met and that assigned projects and other work are completed on time, with high quality, and within budget

Qualification: 

• Advanced Clinical/Science Degree required (e.g., MD, PharmD, PhD, MSN, NP, PA etc.).  BSN with extensive clinical experience may be considered.

Knowledge:

• GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient
• In-depth knowledge of Phase IV/post-marketing drug development is preferred
• Relevant therapeutic area knowledge, dependent on customer base
• Comprehensive understanding of product and safety profiles
• Understanding of managed care, health economics, healthcare reimbursement, managed care customers and the distribution channels relevant to pharmaceutical/biotechnology organizations
• Familiarity with the current legal and regulatory landscape pertinent to the pharmaceutical/biotechnology industry

Required Experience:

• Minimum of 5 years related work experience (clinical, managed care, or industry experience)
• Prior experience as a field medical science liaison is preferred
• 2 or more years’ clinical or health economic research experience (either in industry or in another, related setting) is preferred
• 2 years' experience in therapy area is preferred

Skills:

• Ability to learn other disease or product areas as business needs and product life cycles change

• Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
• Proven track record of meeting or exceeding objectives and goals
• Strong attention-to-detail
• Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas
• Outstanding business acumen; knows the industry, Genentech's business model and value proposition, key competitors and other marketplace factors/dynamics
• Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills; proven ability to effectively and quickly achieve conflict resolution with affected parties and work in a cross functional environment
• Knows how to summarize and communicate complex information and business objectives in a concise and effective way for important presentations and decisions
• Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
• In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening)
• Business travel, by air or car, is required for regular internal and external business meetings (up to 70% of time)
• This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business

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Hematology Thought Leader Liaison – West Region

West (Western Oregon, California/HI ecosystems)

Candidates can live anywhere in the territory/ecosystem and there is a high preference for candidates already living in the geography.

The Hematology Thought Leader Liaison (TLL) supports the franchise and other GNE stakeholders/partners across specific geographic area in building relationships and educating Thought Leaders. In addition, the TLL will leverage their strong relationships with our Thought Leaders to connect them with decision makers across GNE.

Key Responsibilities

Thought Leader Management

•    Identify, profile, and develop deep and trusted relationships with Thought Leaders in Hematology

•    Serve as liaison for National/Regional/Emerging TLs and their engagement across the Genentech/Roche enterprise, including engagements with marketing, senior leadership, ecosystem partners, medical, and global teams

•    Educate TLs to ensure they are up-to-date on our molecules, indications and non-clinical attributes

•    Identify and develop relationships with other therapeutic area influencers, including professional societies and third-party vendors

•    Lead, act and live our Operating Principles in all aspects of work

Marketing Execution

•    Gather, synthesize, and communicate timely, relevant TL insights to help inform Squad Priorities, brand strategies and tactics, and ecosystem objectives

•    Partner with ecosystem team (ie ecosystem marketer, TAM, HD) to help shape ecosystem strategy pull through and tactics

•    Pre-launch – meet with TLs to understand disease state and their beliefs to shape launch strategy

•    Post launch - understand TLs product perception and belief in value proposition, including key driving factors to inform and deliver on amplification strategies and key barriers to inform and deliver on appropriate objection handling strategies

•    Synthesize and report TL insights from congresses, 1:1 meetings and TL connects; discuss implications on brand strategy and tactics with marketing

•    Plan and execute national, regional, community and ecosystem-level advisory boards to gather insights across customers

•    Support home office in tactic execution, for example peer-to-peer education and projects involving KOLs such as podcasts or consulting projects

•    Leadership at conferences including planning and attending conference receptions and coordinating TL engagements

•    Collaborate with T&D and home office marketing on initiatives such as supporting clinical training for the field and TL led education days when entering a new therapeutic area 

Core Competencies:

Achieving Results

•    Is goal-directed, persistent; driven to achieve objectives

•    Holds self accountable for meeting commitments; can flag concerns early, and offer potential solutions to overcome barriers

•    Can identify additional stakeholders to partner with, when necessary, and clearly conveys objectives, deadlines and expectations

•    Consistently communicates clearly with internal and external stakeholders

Technical and Business Expertise

•    Deep knowledge of each customer type (HCPs, financial decision makers, pharmacy directors, payers, pathway decision makers, etc), and understanding of how these customers engage and may influence one another

•    Builds strong relationships with customers; acts as liaison between KOLs and the Genentech organization

•    Deep knowledge of each disease area including competitive landscape

•    Strong clinical acumen—can move customers along the advocacy continuum

Teamwork and Collaboration

•    Working with home office and field partners; consistently exchange information where applicable

•    Demonstrate One GNE behavior—having a larger business perspective beyond the HEME business; thinking with an enterprise mindset

•    Actively seek and incorporate input from others

Strategic Agility

•    Understands the market (internal and external landscapes) and customers to identify opportunities, tradeoffs, and long-term objectives

•    Has a clear line of sight from brand strategy to execution

•    Can synthesize inputs from multiple stakeholders, to frame and simplify complex issues, prioritize, and develop a clear action plan

Inspiring and Influencing

•    Demonstrates leadership among peers by setting a positive example and motivating the team by leveraging one another’s strengths

•    Successfully aligns multiple stakeholders behind a single vision

•    Builds trust and engagement from teammates and partners

•    Demonstrates confidence and leadership presence when presenting to key internal and external stakeholders

Experience:

You are a person with the following qualifications and experience:

•    Bachelors Degree required, advanced degree preferred

•    Prior hematology/oncology experience is strongly preferred

•    Previous experience in multiple commercial functions is a plus

•    Field experience is strongly preferred

•    Average of 5 or more years work experience in the pharmaceutical, biotech or related industry.

•    Proven track record of consistent achievement or overachievement in assigned responsibilities, goals, objectives and any other relevant metrics.

•    Previous experience building, implementing & seamless execution of action plans, programs and related activities.

CMG Operating Principles  

I put the patient first, always. 

I am obsessed with meeting customer needs. 

I act on behalf of the whole company, not just my team. 

I am inclusive.  

I build a culture of trust. 

I have a growth mindset. 

I act with urgency. 

I am accountable. 

I radically simplify and prioritize for impact. 

I follow the science.

I build our reputation.

Roche is an equal opportunity employer.

The Global Head of CMO Clinical Packaging will be responsible for full oversight of outsourced clinical packaging for the Roche Clinical Supply portfolio.  Leading a team of 4-6 CMO Site Managers based in both South San Francisco and Kaiseraugst, Switzerland, the individual will be fully responsible for employee management as well as ownership of the outsourcing business processes and contract manufacturer performance.  Key responsibilities of the team include setting outsourcing strategy; vendor selection, contracting and negotiation; supplier relationship management (SRM); outsourced supply setup coordination; and production execution oversight.

• Lead a global team of CMO Site Managers responsible for implementation and management of clinical contract manufacturing organizations (CMOs) that are needed to meet clinical supply requirements, including primary packaging, syringe/device assembly, clinical labeling and secondary packaging. 
• Continuously monitor outsourcing market dynamics, maintain industry collaborations, and monitor vendor capabilities with an eye towards innovation.
• Lead collaboration with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives at CMOs.
• Set and monitor performance goals for the contract manufacturing or business partnerships.
• Develop solutions to complex clinical packaging challenges with inter-organizational impact.
• Establish and maintain alignment between Genentech/Roche’s goals and objectives and CMOs.
• Support development and continuous improvement with CMOs/partners.
• Proactively identify and/or assess CMO risks and create strategies to avoid or minimize their impact.  Manage the execution of risk mitigation plans.
• Establish strong partner relationships with internal stakeholders (External QA, Procurement, Device Development, Technical Development Teams, and Collaborations team) to enable successful planning and implementation plans of clinical activities at CMOs.
• Establish strong partnership with both clinical study (CDSL) and network (MPP) Planning teams to determine production requirements and evaluate future needs of clinical programs.  Align vendor capacity availability and capabilities within the clinical demand & operations planning (CD&OP) cycle.
• Set performance goals for staff as well as establish departmental strategy and objectives, in alignment with the strategy for Global Clinical Supply
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Identify, design, and implement process and system improvements.

• B.S. or B.A. degree with 12+ years of work experience in the pharmaceutical manufacturing or supply chain industry or Master’s Degree with 10+ years of relevant experience
• Minimum of 5 years of management experience, ideally in a global setting
• Requires strong interpersonal, communication, customer service, organizational and prioritization skills
• Successful demonstration of leadership, teamwork, problem solving, decision making and technical skills
• Working knowledge of Operational Excellence tools (ie. 5S, Visual Factor, TPM, DMAIC, etc.) required.  Green Belt and/or ASCM/APICS certifications preferred.
• Broad understanding of ERP (e.g., SAP) systems, including production planning, detailed scheduling, master data and manufacturing execution.
• Ability to lead cross-functional, multi-location global projects
• Up to 10-20% domestic and international travel

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Job Summary:

The Pilot Plant Technical Specialist II is an important member of the Pilot Plant. They will support day-to-day activities involved in carrying out Process Development experiments with bacterial and CHO culture processes for products from early and late stage research until post market optimization to ensure that new processes are robustly designed and successfully transitioned from development to manufacturing. They will coordinate and execute complex process development experiments in close collaboration with PTDU, PTD, PT customer groups, and act as a member of a high functioning team. Studies executed will support all phases of drug development, process validation/characterization, process and equipment improvements, general troubleshooting and technology development. The candidate will be interfacing with customer groups by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions. 

Job Responsibilities: 

● Ability to work independently with ability to of support complex troubleshooting, training and flexing in 2 work areas/operating systems. 

● Recognized by functional area as an SME resource with broad technical knowledge 

● Collaborate and interact with customer groups and suppliers on routine basis 

● Volunteer help or ideas to benefit colleagues beyond own area 

● Participate as a team member or lead on functional, organizational and cross-functional teams/projects 

● Lead improvements to maintain an organized, safe, and clean work environment 

● Enhances the safety of the Plant through equipment/process improvements 

● Coordinate and perform operations and tasks associated with CHO and bacterial Drug Substance and Drug Product Operations 

● Routinely perform operations such as cleaning, sterilization, batching (media/buffer), and recording/collecting experiment data. 

● Support implementation and optimization of novel methods and techniques 

● Train, coach and mentor junior staff 

● Equipment maintenance and purchase 

● Gives speaker presentations within work group and department 

● Lead troubleshooting efforts on equipment

Job Requirements/Qualifications: 

● BA/BS in a life science or equivalent, with at least two years of relevant work experience 

● Demonstrates proficiency in the application of basic manufacturing, engineering and/or scientific theories, principles and techniques used in biopharmaceutical manufacturing processes. 

● Ability to work in fast paced dynamic work environment 

● Ability to keep clear and accurate written and electronic records of work 

● Strong team player who can work with team of diverse skills and objectives 

● Ability to lead teams or projects that are assigned 

● Possess excellent interpersonal and communication skills 

● Strong problem solving skills 

● Self-motivated, organized and capable of prioritizing deliverables across multiple projects. 

● Mechanical aptitude and ability to lift 30 pound

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Job Summary:

The Pilot Plant Technical Specialist III is an important member of the Pilot Plant. They will support day-to-day activities involved in carrying out Process Development experiments with bacterial and CHO culture processes for products from early and late stage research until post market optimization to ensure that new processes are robustly designed and successfully transitioned from development to manufacturing. They will coordinate and execute complex process development experiments in close collaboration with PTDU, PTD, PT customer groups, and act as a member of a high functioning team. Studies executed will support all phases of drug development, process validation/characterization, process and equipment improvements, general troubleshooting and technology development. The candidate will be interfacing with customer groups by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.

Job Responsibilities: 

● Ability to work independently with ability to of support complex troubleshooting, training and flexing in many work areas 

● Ability to work independently in other operations area and go to where support is required 

● Recognized SME resource with broad technical knowledge sought out by customer groups on routine basis 

● Build productive alliances and partnerships across departments 

● Participate as a team member or lead on functional, organizational and cross functional teams/projects 

● Identify and lead business or process related improvements to maintain an organized, safe, and clean work environment 

● Enhances safety of Plant through equipment/process improvements 

● Coordinate and perform operations and tasks associated with CHO and bacterial Drug Substance and Drug Product Operations 

● Routinely perform operations such as cleaning, sterilization, batching (media/buffer), and recording/collecting experiment data. 

● Train, coach and mentor junior staff 

● Initiate and lead projects that result in implementation and/or optimization of novel methods and techniques 

● Equipment maintenance, design and purchase 

● Gives speaker presentations across departments 

● Identify and lead troubleshooting efforts on equipment 

Job Requirements/Qualifications: 

● BA/BS in a life science or equivalent, with at least five years of relevant work experience 

● Mastery of basic manufacturing, engineering and/or scientific theories, principles and techniques used in biopharmaceutical manufacturing processes. 

● Ability to work in fast paced dynamic work environment 

● Ability to keep clear and accurate written and electronic records of work 

● Strong team player who can work with team of diverse skills and objectives 

● Ability to lead teams or projects that are assigned 

● Possess excellent interpersonal and communication skills 

● Strong problem solving and critical thinking skills 

● Self-motivated, organized and capable of prioritizing deliverables across multiple projects. 

● Mechanical aptitude and ability to lift 30 pounds

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Job Summary:

Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. PTD actively collaborates and develops innovative technical solutions to bridge early-stage, late-stage and commercial product needs.

The PTDO Informatics Team within the PTD organization is responsible for a broad range of IT services and support across small and large molecule technical development, device development, analytical sciences, business operations and supply chain. We provide lab information management systems, data management solutions and web applications to support PTD functions. We collaborate closely with key partners including Research and Early Development (pRED / gRED), Manufacturing (PT) and Quality (PTQ).

Reporting to the Global Head of PTD Informatics, the position will be accountable for management and support of PTD information systems. This position will play a key role in the successful digital transformation of PTD organization by interacting with the product owners of various use cases and defining requirements in an agile and clear manner. 

Job Responsibilities/Tasks:

• Provide strategic direction, prioritization, mobilization of resources aligned to business objectives for Global projects like Digital Transformation.
• Take a leadership role that educates advices and challenges the team members for global projects delivery.
• Work directly with staff at all levels in PTD to understand their information management needs, gather requirements and quickly provide high quality solutions.
• Plan, schedule, and drive one or more platform or informatics software projects at a time and hold regular stakeholder meetings to keep all interested parties updated in project progress.
• Promote and drive innovation in technologies, processes, and tools for cutting-edge software development.
• Provide technical leadership in designing and implementing large scale, complex SaaS/PaaS applications requiring high performance and availability.
• Create, review and provide deep technical analysis of software designs for all areas including security, software patterns, cloud infrastructure, data modeling, resilience, scalability, etc.
• Provide development teams with software architecture, cloud and distributed systems expertise and work with fellow team members (Architects, other Tech Leads and Systems Engineers) to ensure development activities aligned with scope, schedule, priorities and business objectives.
• Responsible for establishing best practices in SaaS/PaaS cloud software development, integration of applications and governance/oversight of detailed designs generated by the team and vendors.
• Review functional specifications, create detailed design and technical specifications, oversee code and test activities.
• Drive all aspects of our agile development process, from sprint planning to daily scrum meetings and sprint demos
• Participate in the Lab of the Future team to create a systems landscape.
• Manage and execute the work using offshore resources who provides the operational support of global projects.
• Interface with vendor support, system administrators, database administrators, and internal application support team to resolve system issues.
• Perform and document risk and impact assessments for upgrades and releases.

Job Requirements/Qualifications:

• Bachelor’s degree in computer science, engineering, business or a related discipline; advanced degree in related field is strongly preferred
• 8 or more years’ experience in developing, releasing and maintaining distributed cloud based applications
• Knowledge of Agile and Scrum Methodology
• Excellent Written and Verbal communication skills
• Proven ability to influence cross-functional teams without formal authority
• Must be able to travel 10-15% of the time internationally
• Experience with machine-to-machine protocols, OPC UA, TCP/IP
• Experience with SOA, REST, SOAP
• High-level understanding of Industry 4.0 concepts
• Very strong technical skills with at least five or more years of hands-on design, coding, integration and deployment experience in enterprise applications
• Extensive experience building highly available globally distributed systems in one or more major cloud providers (AWS, Azure, GCP)
• Knowledge of how to scale distributed micro services based systems using open source and cloud based technologies such as: queues, SQL/No-SQL databases, analytics databases, streams, replication, globally distributed data stores, polyglot data stores, etc.
• Experience with building, deploying and maintaining microservices and applications on Kubernetes
• Understanding of API Gateways, mesh networks, ingress controllers and its uses and integrations with cloud provider abstractions and Kubernetes
• Deep knowledge of containerization platforms like Docker and their role in a microservices distributed cloud architecture
• Extensive experience in two or more: C# (net core), Go, Java, Javascript, Python
• Experience with asynchronous distributed services using message queueing, streaming and pub/sub
• Extensive experience in design and implementation of data and workflow pipelines
• Hands-on experience with designing and executing technical solutions from requirements analysis to design and development to testing and implementation
• Experience with iterative development life cycle methodologies and application of those principles, especially agile development practices
• Demonstrated experience working with vendor partners
• Self-directed, works with limited management direction and exercise considerable latitude in determining technical objectives of assignment

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Title: Content Standards & Governance Lead

Division: PDB - DTO

Location: Mississauga, South San Francisco, Welwyn

Duration: Full Time

The content standards & governance lead is accountable for the end-to-end management of content standards process including requests, definition, and adoption for all content in scope of standardization (Information Products include documents and reusable content blocks- Categories).  Drives and facilitates organization-wide content standardization, re-use, and management of good quality content practices through information citizenship.  

Data Dependent Domain consists of shared content that is dependent on data used across pharma related to clinical trial results focused on Data Dependent writing

Drives Content standardization strategy and is the final decision maker on matters of content strategy

Job Responsibilities

• Manage standards analysts, content modelers and other onshore-offshore resources
• Manage the definition of content standards ensuring appropriate stakeholder involvement across the business, incorporating related industry and regulatory standards/requirements.
• Steward existing standards ensuring they are current, approved and aligned with business sponsors meeting end-to-end business needs and promoting content reuse and data alignment.
• Educate and oversees appropriate training of those that use the standard such as content owners, process owners and stakeholders on the correct application of the standards
• Final decision maker for data-dependent content standards and their application, with escalation to / oversight by governing bodies
• Coordinate teams that execute the content standardization related activities
• Oversee reference and master content management execution associated with controlled vocabulary and or libraries if the Content Management Office directly manages their reference content
• Manage their metadata repository in Collibra and glossary content for their domain in our defined standards repositories (might include SCM, ACG, and other standards repositories as well)
• Periodic review and update of existing standards to ensure relevance  and meet current requirements
• Oversee standards governance for their domain including standards adoption - partnering with content owners, systems owners, process, report, and content and data quality owners; and related functional leaders
• Recognized as an expert in standards and associated metadata within their domain
• Know and engage all stakeholders and represents their interests along with E2E thinking ensuring fit for purpose agreements
• Manage and enable the content standards development core team and their activities
• Manage their domain stakeholder/SME teams and the stakeholder’s communities ensuring cross-functional engagement in the standards process.  (enabling inclusive perspectives, yet not consensus per se) 
• Monitor ongoing content fidelity (e.g. quality, consistency, adoption) levels and other metrics which assess the adherence of content, reuse strategies, and related governance policies/Standards
• Work within and beyond their immediate area to implement change in support of the adoption of content governance policies and standards
• Facilitates compliance to external content regulations including CDISC, CFR Part 11, HIPAA, etc. and internal quality, regulatory and audit requirements

External Customers:

• Project Leaders/Managers, Global Process Owners, Domain Stakeholder / Subject Matter Expert Team, System Owners, Information and Content Architects
• Content Owners, Content Operations Managers, Report Owners, Functional Leadership and Governance Teams, Cross-Functional Content Governance Offices
• Business Leaders, Global Information Standards Governance Committee, Functional Leadership and Governance Teams, Compliance/Regulatory Experts

Qualifications

• Bachelor's degree in science, analytics or biology-related field, (Masters degree preferred)
• 6 or more years’ professional experience in the pharmaceutical/ biotechnology industry or related experience (preferably in clinical development)
• Extensive Content Management and Medical Writing experience in pharma research and development environment - 5 years min. 
• Strong problem-solving skills
• Strong written and verbal communication skills

• Demonstrates a deep and comprehensive understanding of the importance and impact of content and dependent data  (or bad content) on the ability of the business to meet its own objectives.
• Ability to navigate and influence complex organizational and cross-functional relationships
• Ability to clearly communicate business case problem statements and supporting cost-benefit analysis
• Experience with content development life cycle
• Knowledge of content modeling and reuse strategies/architecture principles and techniques
• Knowledge of process management and maturity methodologies
• Knowledge of data & content integration strategies
• Knowledge of Structured Content Management Systems
• Knowledge of Auto Content Generation and Natural Language Generation as it applies to Structured Content Design
• Travel Requirement up to 20%

Qualified candidates are encouraged to submit cover letter and resume no later than June 8th, 2020.

This position is not eligible for relocation support.

This position is open to applicants legally authorized to work in Canada.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Senior Administrative Associate:

Pharma Technical Assets (PTA) enables PT to deliver our products to patients through world-class asset performance.  We protect our right to operate, build leading capabilities in lean and agile ways of working and work to advance company-wide collaboration.  We are seeking a senior Administrative Associate who can excel in our fast-paced dynamic environment.

The candidate will provide administrative support in partnership with our PTA administrative team to the PTAA and PTAC leadership teams.  The successful candidate will succeed not just by completing tasks, but also by proactively identifying and anticipating the needs of the eLT members, effectively leveraging company resources, and demonstrating flexibility in planning work activities to maximize department productivity.  The successful candidate also must have the flexibility to handle a large volume of routine and non-routine work while providing a consistently accurate work product.  The successful candidate must have strong, positive interpersonal skills and experience working across cultures and with individuals at all levels of the Genentech/Roche organization.

Duties:

• Manage multiple schedules including global (US, EU) meetings, and meeting with external parties
• Arrange, negotiate, coordinate and support meetings, events, and activities both on and off-site 
• Organize, disseminate and maintain documents and information, as per PTA best practices.
• Develop, implement and continuously improve administrative work processes, procedures, and systems; ensure compliance with company policies.
• Collaborate closely with other admins in the organization, including backing up each other.
• Work within the broader admin team to ensure aligned work practices and leverage them for peer-to-peer learning 
• Manage deadlines related to business planning as well as other special projects
• Train new team members on company and departmental administrative and general processes, systems, practices, tools and standards
• Coordinate, schedule, and facilitate townhalls, staff meetings, and other departmental activities
• Provide program coordination support for PT Development Programs

General office responsibilities include but are not limited to: 

• Schedule travel, and process payment and expense reports for sr. leaders in the organization, and facilitate obtaining travel documentation (e.g. visas)
• Coordinate hiring process, including travel, recruiting activities, scheduling and managing interviews
• Coordinate onboarding/off-boarding, maintain org charts and distribution lists
• Manage visits by external speakers, vendors and consultants
• Create and prepare presentation materials
• Help setup contracts for consultants
• Processing purchase orders (POs), tracking invoices and associated interactions with Contracts and Finance groups
• Scanning, copying, distributing and filing documents
• Document and data entry into on-line databases and document management systems
• Data entry into on-line resource management systems 
• Maintain and update websites
• Order office supplies; maintain equipment; disseminate mail and organize (“5S”) / maintain mail/photocopy room
• Order catering and other supplies for a variety of meetings and events
• Track workspace allocation and office moves for PTA members

Requirements:

• Strong administrative organizational and technical skills that demonstrate attention to detail, ability to work independently and in teams, strong follow up skills, and ability to prioritize and manage multiple projects simultaneously.
• Strong communication skills (email, professional writing and verbal) and ability to interact with people at various levels (entry level up to Sr. VP)
• Experience in handling sensitive, confidential and complex information. 
• Demonstrated problem solving and decision-making skills within agreed parameters.
• Strong computer skills utilizing MS Word, PowerPoint, Excel, Trello, Google Apps (gMail, Docs, Sites, Drive, Calendar, Sheets, Forms, Slides, Hangouts, Jamboard), Zoom, WebEx; experience with Sharepoint or similar document management system.
• Interest and capability to learn various software systems used at Genentech for management of assets and resources. 
• Excellent written and verbal skills
• Education & Experience:  BA or equivalent experience (at least 5 years previous administrative experience)

Role Summary:

The Senior Health Economist should have strong technical expertise in Health Economics and Outcomes Research (HEOR). H/She should be able to develop an HEOR strategic plan and independently conduct HEOR research projects including economic modeling, real world data research and patient-reported outcomes research. This individual should be able to independently manage outside vendors and/or work collaboratively with internal data scientists from the technical institute to conduct HEOR to support one or more disease areas or molecules, and present results at internal meetings or external conferences. H/She should be able to engage with external customers and therapeutic area experts.

Qualifications

Masters +/- PharmD, Doctoral Degree

4+ years of industry experience

Key Accountabilities

• Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget.
• Able to appropriately select and manage vendors and resources, including submission of information for contracting and other internal processes and making sure projects are completed within timeline and allocated budget.
• Develop, build and maintain internal and external collaborative relationships. Able to work collaboratively internally with data scientists, medical, commercial and field colleagues. Individual must be able to engage collaboratively with customers, therapeutic area experts and HEOR experts. 
• Able to own their own professional development and identify opportunities to develop leadership and technical skills. Demonstrated ability to keep abreast of new methods and advancements in the field of HEOR and Health Services Research.
• Comply with all company policies and regulations.

Responsibilities

• Demonstrated ability to develop an HEOR strategic plan and associated tactics under minimal supervision. 
• Able to independently execute HEOR projects with no supervision.
• At project conceptualization, individual is able to identify opportunities for pull through the evidence generated through HEOR projects into publications and other promotional or reactive materials. Individual should be able to present and discuss HEOR project methods and findings to a diverse audience. 
• Able to develop therapeutic area knowledge and expertise and be able to engage with experts in the HEOR area for specific disease areas. 
• Able to participate in cross-functional initiatives to represent E4A. 

Core Competencies

• Enforces high performance standards and takes appropriate and direct action when they are not met.
• Develops an iterative and collaborative approach to obtain insights into complex issues and responds to change when needed.
• Facilitates and engages in healthy debate and constructive resolutions to conflict or differing view points. 
• Accurately assesses team member capabilities and adjusts responsibilities and/or provide support to optimize team performance.
• Checks-in regularly with stakeholders to understand their needs, perspectives etc. and strengthen relationships.
• Understands the organizational culture; uses norms and language that produce the best response.
• Draws ideas from seemingly unrelated situations or experiences and adapts them to the situation at hand
• Exercises good judgement in decision-making based on expertise and advice seeking in the face of ambiguous circumstances.

CMG Operating Principles

I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive.

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

I act with integrity.

At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.

As the DSS Head of Data Science Enabling Technologies (DSET) you will lead a multidisciplinary team of Data Scientists that provide advanced analytics and data engineering expertise to DIS organization to develop functionality of DIS product portfolio and services; develop shared data and analytics capabilities for DIS solutions and R&D and that support Diagnostics business with services in Data Science Enabling Technologies. These services include evaluation and use of state-of-the-art technologies and frameworks to enable (cloud-based) clinical workflow (CWF) and clinical decision support (CDS) solutions, identification, evaluation and use of internal and external data to design, prototype, test and further develop data commons and individual components, and to confirm and to validate their functionality; actively pursues a vision to implement and foster F.A.I.R. data principles.

You will develop the strategic vision for the function and ensures the objectives, standards, deadlines and other requirements set by the business are achieved and create effective relationships with entire DIS organization and Diagnostics IT teams (near- and off-shore), Data Management Office, Business Development and Strategy functions, as well as forges an active working relationship with Data Science and Data Engineering groups across Roche group.

You further expand the capabilities of the team and develop the team and while maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Your main responsibilities will be:

• Actively support DIS organization in identifying and delivering data science enabling technologies for Navify product portfolio
• Actively pursue the implementation of F.A.I.R. data principles in DIS and advocates their adoption across the division
• Actively collaborate with Diagnostics IT (near and off-shore), Data Management Office, and other Data Science and Data Engineering teams in the Roche group
• Manage DSET resources to ensure delivery, i.e.: best allocation of team to respective DIS products, studies, services ensuring highest quality of work
• Ensure new and innovative data sources, state-of-the-art technologies and frameworks are evaluated and implemented as appropriate to business needs.
• Establish and maintain relationships with key opinion leaders in the field and talents with relevance for DSET, both outside and inside the company.
• Manage DSET Team of direct reports; and specifically:
  • recruit, ensure training and organize work for the team
  • set functional and individual goals and objectives which are in line with the DIS strategy
  • provides support to deliver individual goals
  • ensure effective allocation of team members to utilize individuals’ strengths and maximize outcomes
  • assess individual performance on an ongoing basis and at regular review sessions
  • propose actions to further develop team members

• Communicate a clear strategic vision with enthusiasm and a passion for success
• Facilitate the effective sharing of experiences and knowledge within the team
• Develop the talent pool, including development and management of succession plan
• Plan and control the functional budget

Who you are

You’re someone who wants to influence your own development. You’re looking to be part of a dynamic and growing organization where you have the opportunity to pursue your interests across functions and geographies.

We are looking for these qualifications:

• Ph.D. in Data Science related field (Statistics, Computer Science, Mathematics or similar areas of academic discipline)
• Min 12 years of professional experience in healthcare or a related field
• Experience in using advanced data science techniques to solve complex business problems
• Experience in managing Data Scientists and Data Engineers
• Prior experience working in the Diagnostics industry is a plus
• Good knowledge of English in a business environment

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.