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Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics. Genentech has numerous molecules in Phase I, II and III clinical trials in neuroscience disease areas including but not limited to Spinal Muscular Atrophy (SMA), Huntington’s Disease (HD), Alzheimer's and Autism.  Additional information on Genentech’s neuroscience pipeline can be found here - https://www.gene.com/medical-professionals/pipeline Rare Diseases are common in neurology and due to the prevalence of neurological symptoms in rare diseases- of the estimated 7,000 known rare diseases that lead to significant morbidity and mortality in 25 million people in the United States, a third are thought to include a neurological component.

People with neurological rare diseases often wait for a long time for a correct diagnosis and treatment.  Although a limited number of orphan drugs are approved for neurological conditions, many orphan drugs are in development.  People living with a neurological rare disease and their caregivers are highly engaged in their treatment and with their communities via local advocacy chapters where they often attend meetings and events along with the HCPs. Our marketing team is working closely with our legal and compliance partners to ensure we are prepared to support our customers while engaging compliantly and consistent with our values. As we embark on this journey, we are seeking to build strong, customer-focused teams who will represent Genentech with integrity.

The Neurological Rare Disease Area Care Team Manager (Front Line Manager) is responsible for leading a cross functional team whose responsibilities will be focused on supporting patient, caregivers, HCP and advocacy needs holistically within the community.  To ensure both clinical and access questions are compliantly addressed for the patient, caregivers and HCP accounts including other geographically aligned stakeholders ie.. social workers, genetic counselors, health systems etc. in order to provide safe and effective patient care.  Success in this role will, at times, require the Area Care Team Managers to balance needs of multiple products, stakeholders and team member responsibilities based on specific local account and geography needs. They will need to strategically manage their business opportunities, lead highly integrated teams while maintaining individual customer accountabilities.  The Field Incentive Compensation plan drivers include MBOs.

The Area Care Team Manager is responsible for leading and coaching their team of Patient Assistance Liaisons and Neurological Rare Disease Specialists:

Patient Assistance Liaison (aka PAL’s)

• Builds trust in Genentech and compliantly provides information and support to patients, caregivers, and the Neuro RD community around them.  

• The team will be focused on compliantly supporting patients’ clinical and access needs and caregivers as they seek information about their disease and potential treatment options.

• They will work to minimize reimbursement barriers to GNE products for patients and providers.  

• The FLM and PALs will cultivate collaborative and integrity-based relationships with local community stakeholders who serve patient and caregivers (Advocacy groups)

Neurological Rare Disease Specialist

• Builds trust in Genentech and provides information and support to HCPs, health systems and the community around them.  

• Understands needs of providers and works to compliantly provide on-label clinical information and services to help support safe and effective patient care

• They will work to minimize reimbursement barriers to GNE products for patients and providers.  

• Neurology Rare Disease Specialists support Brand Performance goals and have MBO evaluation

The FLMs lead their teams to support brand goals and targets by working closely with key business partners such as Brand Marketing, Sales Operations, and Commercial Training & Development, Access Solutions among others.

They may need to attend events and meetings during evenings and weekends.  This person is expected to prioritize these events and meetings in order to represent Genentech and support patients and caregivers in their communities.  While work hours are typically not to exceed 40 hours per week, flexible schedules to accommodate evening and weekend work will be operationalized

The candidate must live within their geography and in the contiguous US.  It is strongly preferred that the candidate lives near a major metropolitan airport.

Specific Responsibilities Include:

• Represent Genentech within local neurology rare disease communities prior to launch and product availability during which they will build relationship with advocacy program managers/others at local advocacy chapters to help create a positive, trusted, and lasting presence of Genentech in community.  

• The ACT Managers will represent Genentech in communities while assessing local community and business needs to inform hiring of a strong team

• Introduces and represents Genentech at local community-based and chapter-related events (e.g., walks, exhibits, education events, chapter meetings, etc.) and as appropriate at national community events, often on weekends and evenings.  It is expected that this responsibility will greatly reduce, yet continue to some extent after hiring a full-team due to interest and need to support larger events with more than one Genentech representative

• Serves as a local point of contact for patients and caregivers who opt into relationship with Genentech, meeting directly with patient/caregivers as needed to address questions about Genentech and unbranded disease education as approved for use in period prior to launch and on-boarding of full team

• Communicates proactively with internal partners/ stakeholders regarding the internal/ external reimbursement landscape.

• Works with internal partners/stakeholders to develop and track MBOs of team to enable efficient & effective tracking of progress and results from implementation of reimbursement strategies, plans and tactics

• Work with the Brand and Planning managers on Access Solutions strategies and tactics to support the team

• Meets and communicates with relevant external societies

• Assesses, analyzes, recommends, prepares and implements appropriate business plans that will support brand goals and ensure performance goals are achieved.

• Cascades area operating budgets and workforce plans to the territory levels to ensure optimal workforce representation and alignment to meet assigned financial and other brand goals and targets.

• Works with manager, peers, team members and/or other partners/stakeholders to continually assess area strategies, plans and incremental activities.

• Leads the team overall to regularly identify new/enhanced or extended opportunities to increase field performance in the assigned area or beyond.

• Ensures field operations are aligned with Neuroscience Marketing and that team members have all marketing-related materials, appropriate to their roles and responsibilities, in a timely manner. Ensures area team compliance with materials' guidelines and direction.

• Works closely with Commercial Training & Development to help develop programs/offerings, as well as ensure compliant participation among team in appropriate training & development programs and other opportunities.

• Has customer responsibilities as appropriate with speakers, KOLs, SPs, Congresses etc.

• Partners as appropriate across all field team members within assigned area of responsibility to ensure positive customer experience

• Hires, develops and oversees the work of direct and indirect reports.

• Complies with all laws, regulations and policies that govern the conduct of Genentech activities and consistently demonstrating high ethical and professional standards with all customers and business

Key Competency Profile:

• Feedback and Coaching

• Teamwork and Collaboration

• Inspiring and Influencing

• Strategic Agility/ Navigating Ambiguity

• Technical and Business Expertise

• Innovation

Demonstrate Leadership Commitments:

The selected candidate should be able to demonstrate that they strive to lead by example, consistently demonstrating our values of Integrity, Courage and Passion. This means:

• I take a genuine interest in people.

• I listen carefully, tell the truth, and explain “the why”.

• I empower and trust people to make decisions.

• I discover and develop the potential in people.

• I strive for excellence and extraordinary results.

• I set priorities and simplify work.

• I congratulate people for a job well done.

Qualifications and Experience:

• Bachelors Degree

• MBA or other related graduate-level degree is preferred

• Average of 8 or more years' work experience

• A minimum of 3 years' previous field management experience in a traditionally-structured franchise in the pharmaceutical, biotech, or related industry

• 2 years or more previous experience in product marketing or similar experience in the pharmaceutical/biotech/or related industry is strongly preferred

• Previous account management or other Managed Care experience is a plus

• Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals

• Previous direct to patient, clinical education or rare disease experience strongly valued

• Previous experience in completing and implementing attainable divisional-level business plans

• 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 regularly required

Important Note:

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.

Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics. Genentech has numerous molecules in Phase I, II and III clinical trials in neuroscience disease areas including but not limited to Spinal Muscular Atrophy (SMA), Huntington’s Disease (HD), Alzheimer's and Autism.  Additional information on Genentech’s neuroscience pipeline can be found here - https://www.gene.com/medical-professionals/pipeline Rare Diseases are common in neurology and due to the prevalence of neurological symptoms in rare diseases- of the estimated 7,000 known rare diseases that lead to significant morbidity and mortality in 25 million people in the United States, a third are thought to include a neurological component.

People with neurological rare diseases often wait for a long time for a correct diagnosis and treatment.  Although a limited number of orphan drugs are approved for neurological conditions, many orphan drugs are in development.  People living with a neurological rare disease and their caregivers are highly engaged in their treatment and with their communities via local advocacy chapters where they often attend meetings and events along with the HCPs. Our marketing team is working closely with our legal and compliance partners to ensure we are prepared to support our customers while engaging compliantly and consistent with our values. As we embark on this journey, we are seeking to build strong, customer-focused teams who will represent Genentech with integrity.

The Neurological Rare Disease Area Care Team Manager (Front Line Manager) is responsible for leading a cross functional team whose responsibilities will be focused on supporting patient, caregivers, HCP and advocacy needs holistically within the community.  To ensure both clinical and access questions are compliantly addressed for the patient, caregivers and HCP accounts including other geographically aligned stakeholders ie.. social workers, genetic counselors, health systems etc. in order to provide safe and effective patient care.  Success in this role will, at times, require the Area Care Team Managers to balance needs of multiple products, stakeholders and team member responsibilities based on specific local account and geography needs. They will need to strategically manage their business opportunities, lead highly integrated teams while maintaining individual customer accountabilities.  The Field Incentive Compensation plan drivers include MBOs.

The Area Care Team Manager is responsible for leading and coaching their team of Patient Assistance Liaisons and Neurological Rare Disease Specialists:

Patient Assistance Liaison (aka PAL’s)

• Builds trust in Genentech and compliantly provides information and support to patients, caregivers, and the Neuro RD community around them.  

• The team will be focused on compliantly supporting patients’ clinical and access needs and caregivers as they seek information about their disease and potential treatment options.

• They will work to minimize reimbursement barriers to GNE products for patients and providers.  

• The FLM and PALs will cultivate collaborative and integrity-based relationships with local community stakeholders who serve patient and caregivers (Advocacy groups)

Neurological Rare Disease Specialist

• Builds trust in Genentech and provides information and support to HCPs, health systems and the community around them.  

• Understands needs of providers and works to compliantly provide on-label clinical information and services to help support safe and effective patient care

• They will work to minimize reimbursement barriers to GNE products for patients and providers.  

• Neurology Rare Disease Specialists support Brand Performance goals and have MBO evaluation

The FLMs lead their teams to support brand goals and targets by working closely with key business partners such as Brand Marketing, Sales Operations, and Commercial Training & Development, Access Solutions among others.

They may need to attend events and meetings during evenings and weekends.  This person is expected to prioritize these events and meetings in order to represent Genentech and support patients and caregivers in their communities.  While work hours are typically not to exceed 40 hours per week, flexible schedules to accommodate evening and weekend work will be operationalized

The candidate must live within their geography and in the contiguous US.  It is strongly preferred that the candidate lives near a major metropolitan airport.

Specific Responsibilities Include:

• Represent Genentech within local neurology rare disease communities prior to launch and product availability during which they will build relationship with advocacy program managers/others at local advocacy chapters to help create a positive, trusted, and lasting presence of Genentech in community.  

• The ACT Managers will represent Genentech in communities while assessing local community and business needs to inform hiring of a strong team

• Introduces and represents Genentech at local community-based and chapter-related events (e.g., walks, exhibits, education events, chapter meetings, etc.) and as appropriate at national community events, often on weekends and evenings.  It is expected that this responsibility will greatly reduce, yet continue to some extent after hiring a full-team due to interest and need to support larger events with more than one Genentech representative

• Serves as a local point of contact for patients and caregivers who opt into relationship with Genentech, meeting directly with patient/caregivers as needed to address questions about Genentech and unbranded disease education as approved for use in period prior to launch and on-boarding of full team

• Communicates proactively with internal partners/ stakeholders regarding the internal/ external reimbursement landscape.

• Works with internal partners/stakeholders to develop and track MBOs of team to enable efficient & effective tracking of progress and results from implementation of reimbursement strategies, plans and tactics

• Work with the Brand and Planning managers on Access Solutions strategies and tactics to support the team

• Meets and communicates with relevant external societies

• Assesses, analyzes, recommends, prepares and implements appropriate business plans that will support brand goals and ensure performance goals are achieved.

• Cascades area operating budgets and workforce plans to the territory levels to ensure optimal workforce representation and alignment to meet assigned financial and other brand goals and targets.

• Works with manager, peers, team members and/or other partners/stakeholders to continually assess area strategies, plans and incremental activities.

• Leads the team overall to regularly identify new/enhanced or extended opportunities to increase field performance in the assigned area or beyond.

• Ensures field operations are aligned with Neuroscience Marketing and that team members have all marketing-related materials, appropriate to their roles and responsibilities, in a timely manner. Ensures area team compliance with materials' guidelines and direction.

• Works closely with Commercial Training & Development to help develop programs/offerings, as well as ensure compliant participation among team in appropriate training & development programs and other opportunities.

• Has customer responsibilities as appropriate with speakers, KOLs, SPs, Congresses etc.

• Partners as appropriate across all field team members within assigned area of responsibility to ensure positive customer experience

• Hires, develops and oversees the work of direct and indirect reports.

• Complies with all laws, regulations and policies that govern the conduct of Genentech activities and consistently demonstrating high ethical and professional standards with all customers and business

Key Competency Profile:

• Feedback and Coaching

• Teamwork and Collaboration

• Inspiring and Influencing

• Strategic Agility/ Navigating Ambiguity

• Technical and Business Expertise

• Innovation

Demonstrate Leadership Commitments:

The selected candidate should be able to demonstrate that they strive to lead by example, consistently demonstrating our values of Integrity, Courage and Passion. This means:

• I take a genuine interest in people.

• I listen carefully, tell the truth, and explain “the why”.

• I empower and trust people to make decisions.

• I discover and develop the potential in people.

• I strive for excellence and extraordinary results.

• I set priorities and simplify work.

• I congratulate people for a job well done.

Qualifications and Experience:

• Bachelors Degree

• MBA or other related graduate-level degree is preferred

• Average of 8 or more years' work experience

• A minimum of 3 years' previous field management experience in a traditionally-structured franchise in the pharmaceutical, biotech, or related industry

• 2 years or more previous experience in product marketing or similar experience in the pharmaceutical/biotech/or related industry is strongly preferred

• Previous account management or other Managed Care experience is a plus

• Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals

• Previous direct to patient, clinical education or rare disease experience strongly valued

• Previous experience in completing and implementing attainable divisional-level business plans

• 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 regularly required

Important Note:

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.

Summary of Position:

PV Clinical Associate performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The PV Clinical Associate leads clinical review of USDS cases (processed in-house or externally by the vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Associate.

Key Accountabilities:

• Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures(SOPs)
• Reviews, evaluates, and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
• Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
• Responsible for Clinical Review of cases processed in-house and by vendors
• Understands case processing data to evaluate error rates and potential compliance impact
• Performs trend analysis of vendor case processing issues and escalates to vendor and USDS management
• Responsible for developing executive summary on the quality trends observed on a quarterly basis
• Responsible for training internal USDS and/or vendors staff or team in collaboration with SP PV oversight based on trend analysis
• Responsible for ensuring appropriate data correction in the safety database for identified issues or errors
• Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Associate/Vendor staff via the communication module
• Accountable for training internal and external staff members on using communication module
• Performs daily reconciliation of outgoing communications
• Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)
• Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
• Supports PV Clinical Specialists in tasks and projects as needed
• Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
• Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management
• Responsible for the preparation and development of Drug Safety presentations and participates in the education offer internal /external stakeholders as applicable
• Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database  per Genentech/Roche SOPs
• Provide support during audits and inspections•Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified for Success:

• Demonstrates capability to comprehend medical information
• Demonstrates ownership, initiative and accountability
• Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing     the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
• Demonstrates strong, dynamic leadership skills
• Works well independent or within teams and is effective in collaborating with others internally and externally
• Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve   problems and effectively make decisions of moderate complexity and scope e.g., evaluate, interpret and present highly complex data
• Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
• Ability to flex and thrive in an agile and fast-changing environment
• Strong attention-to-detail

Education, Experience, and Other Requirements:

• Health Care Professional degree (Required)
• Minimum 0-2 years of clinical experience (Required)
• Writing experience; science/medical writing (Required)
• Computer proficiency (Required)
• Data entry experience (Preferred)
• Able to travel as per business needs

Summary of Position:

PV Clinical Associate performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The PV Clinical Associate leads clinical review of USDS cases (processed in-house or externally by the vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Associate.

Key Accountabilities:

• Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures(SOPs)
• Reviews, evaluates, and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
• Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
• Responsible for Clinical Review of cases processed in-house and by vendors
• Understands case processing data to evaluate error rates and potential compliance impact
• Performs trend analysis of vendor case processing issues and escalates to vendor and USDS management
• Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Associate/Vendor staff via the communication module
• Accountable for training internal and external staff members on using communication module
• Performs daily reconciliation of outgoing communications
• Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)
• Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
• Supports PV Clinical Specialists in tasks and projects as needed
• Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
• Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management
• Responsible for the preparation and development of Drug Safety presentations and participates in the education offer internal /external stakeholders as applicable
• Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database  per Genentech/Roche SOPs
• Provide support during audits and inspections•Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified for Success:

• Demonstrates capability to comprehend medical information
• Demonstrates ownership, initiative and accountability
• Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing     the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
• Demonstrates strong, dynamic leadership skills
• Works well independent or within teams and is effective in collaborating with others internally and externally
• Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve   problems and effectively make decisions of moderate complexity and scope e.g., evaluate, interpret and present highly complex data
• ​Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
• Ability to flex and thrive in an agile and fast-changing environment
• Strong attention-to-detail

Education, Experience, and Other Requirements:

• Health Care Professional degree (Required)
• Minimum 0-2 years of clinical experience (Required)
• Writing experience; science/medical writing (Required)
• Computer proficiency (Required)
• Data entry experience (Preferred)
• Able to travel as per business needs

Summary of Position:

PV Clinical Associate performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The PV Clinical Associate leads clinical review of USDS cases (processed in-house or externally by the vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Associate.

Key Accountabilities:

• Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures(SOPs)
• Reviews, evaluates, and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
• Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
• Responsible for Clinical Review of cases processed in-house and by vendors
• Understands case processing data to evaluate error rates and potential compliance impact
• Performs trend analysis of vendor case processing issues and escalates to vendor and USDS management
• Responsible for developing executive summary on the quality trends observed on a quarterly basis
• Responsible for training internal USDS and/or vendors staff or team in collaboration with SP PV oversight based on trend analysis
• Responsible for ensuring appropriate data correction in the safety database for identified issues or errors
• Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Associate/Vendor staff via the communication module
• Accountable for training internal and external staff members on using communication module
• Performs daily reconciliation of outgoing communications
• Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)
• Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
• Supports PV Clinical Specialists in tasks and projects as needed
• Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
• Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management
• Responsible for the preparation and development of Drug Safety presentations and participates in the education offer internal /external stakeholders as applicable
• Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database  per Genentech/Roche SOPs
• Provide support during audits and inspections•Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified for Success:

• Demonstrates capability to comprehend medical information
• Demonstrates ownership, initiative and accountability
• Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing     the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
• Demonstrates strong, dynamic leadership skills
• Works well independent or within teams and is effective in collaborating with others internally and externally
• Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve   problems and effectively make decisions of moderate complexity and scope e.g., evaluate, interpret and present highly complex data
• Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
• Ability to flex and thrive in an agile and fast-changing environment
• Strong attention-to-detail

Education, Experience, and Other Requirements:

• Health Care Professional degree (Required)
• Minimum 0-2 years of clinical experience (Required)
• Writing experience; science/medical writing (Required)
• Computer proficiency (Required)
• Data entry experience (Preferred)
• Able to travel as per business needs

As a Real World Data (Senior) Data Scientist within our Personalized HealthCare function you will conduct observational studies 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.

You will collaborate with peers within the function and across the whole organization (e.g. Medical Affairs, Market Access, Drug Safety, Clinical Science, affiliates) to develop evidence generation strategies, identify evidence gaps and data sources, design and execute studies, and implement analyses to address molecule and disease area questions. Your research will be used in reimbursement dossiers, regulatory filings, publications and others.

You will contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our business and healthcare environments. This will require a good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical expertise in observational research. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to transform the way we use data and analytics to develop and deliver medicines for our patients.

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, collaborations, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, processes, etc. to enable broader and more effective use of data and analytics to support business.

MINIMUM QUALIFICATIONS

• MSc or PhD in epidemiology, pharmacoepidemiology, outcomes research, health services research or biostatistics/public health (with focus on epidemiology/ observational research)
• 4+ years of relevant work experience
• Demonstrated track record of developing and executing epidemiological or outcomes research projects, 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
• Proficiency in English, both written and verbal
• Track record of effectively working in a matrix environment with global, international team members coming from scientific, business and operational backgrounds, using influence without authority

PREFERRED/ADDITIONAL QUALIFICATIONS

• PhD degree as listed in Minimum Qualifications
• Proven ability to translate and communicate complex study design and findings to diverse audiences

#LI-PDHB2

Local Candidates Only

Objectives and scope of position:

The Pipeline & Portfolio Planning (PPP) group, within Portfolio & Product Development Strategy (PPS), drives proactive portfolio management, product development strategy, and lifecycle planning. As a trusted partner to teams and decision makers, PPP delivers robust portfolio strategies, guides investment decisions, provides portfolio insights and analytics, and supports decision making to maximize Roche late stage portfolio value for the benefit of patients and Roche.

The Cross-Portfolio Manager/Senior Manager leads or supports various strategic planning and portfolio reporting processes and/or initiatives and/or tools across late stage and the REDs, supporting both colleagues in PPP and project teams, as well as governance and partners in GPS, Finance, Partnering etc.

Major Responsibilities and Accountabilities: (as appropriate)

• Lead/support PPP in cross-functional initiatives, cross portfolio analytics, portfolio reviews and portfolio strategy development.  Support the Late Stage portfolio committee in developing / refreshing TA strategies, and assessing portfolio level options for sustainable value generation
• Lead/support development of frameworks, processes and tools to streamline and standardize the strategic planning process across Late Stage, and identify ways to coordinate and align with other groups (REDs, Partnering etc.)
• Lead/support evaluation of portfolio against evolving stakeholder needs, competitive pressures, and other market dynamics to identify and lead/support ad-hoc strategic initiatives related to growth drivers, portfolio gap analysis, competitive positioning, market disruptors, value chain trends etc.
• Maintain knowledge of company products, competition, and broader market dynamics that frame the business context both present and over the next few years, and act as a thought partner in strategic discussions outside of own projects
• Lead/support regular reports on the status/progress of portfolio, incl. the REDs.
• Lead/support R&D benchmarking efforts and dissemination of portfolio-level insights.
• Lead/support cross PPP/PPS/PD projects and deliverables as appropriate.
• People/team/system/project management as appropriate.

Qualification, Experience and Expertise:

• Advanced degree in science, business, engineering or related field; MBA or PhD a plus.
• Knowledge of drug development, R&D trends, strategy and markets; preferably through at least 3-5 years’ work experience in biotech, pharmaceuticals or a related field.
• Demonstrated strong analytic / modeling and strategic skills; ability to craft and deliver clear presentations to management and teams.
• Ideal candidate will have 2-5 years of experience in management consulting, investment banking, strategic planning, market planning or business development. Strong financial acumen (e.g., valuation and decision analysis) in a plus.
• Ability to identify, scope and manage strategic projects, maintain responsibility for deliverables and timelines, adapt to shifting priorities, and manage stakeholder relationships and expectations
• Strong communication and presentation skills.
• Understanding of relevant portfolio management tools, systems and software.
• Strong communicator; ability to build cross-functional partnerships and influence without authority.

#LI-PDBA1

Summary of Position:

PV Clinical Associate performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The PV Clinical Associate leads clinical review of USDS cases (processed in-house or externally by the vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Associate.

Key Accountabilities:

• Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures(SOPs)
• Reviews, evaluates, and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
• Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
• Responsible for Clinical Review of cases processed in-house and by vendors
• Understands case processing data to evaluate error rates and potential compliance impact
• Performs trend analysis of vendor case processing issues and escalates to vendor and USDS management
• Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Associate/Vendor staff via the communication module
• Accountable for training internal and external staff members on using communication module
• Performs daily reconciliation of outgoing communications
• Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)
• Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
• Supports PV Clinical Specialists in tasks and projects as needed
• Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
• Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management
• Responsible for the preparation and development of Drug Safety presentations and participates in the education offer internal /external stakeholders as applicable
• Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database  per Genentech/Roche SOPs
• Provide support during audits and inspections•Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified for Success:

• Demonstrates capability to comprehend medical information
• Demonstrates ownership, initiative and accountability
• Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing     the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
• Demonstrates strong, dynamic leadership skills
• Works well independent or within teams and is effective in collaborating with others internally and externally
• Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve   problems and effectively make decisions of moderate complexity and scope e.g., evaluate, interpret and present highly complex data
• ​Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
• Ability to flex and thrive in an agile and fast-changing environment
• Strong attention-to-detail

Education, Experience, and Other Requirements:

• Health Care Professional degree (Required)
• Minimum 0-2 years of clinical experience (Required)
• Writing experience; science/medical writing (Required)
• Computer proficiency (Required)
• Data entry experience (Preferred)
• Able to travel as per business needs

The Medical Director at Genentech puts patients and science at the center of all actions. They drive medical strategy and tactics aimed at maximizing medical progress. They collaborate to drive timely data generation and dissemination. They are expected to maintain an in-depth understanding of the medical strategy and relevant clinical and payer issues, while ensuring Genentech's partners understand key trends and shifts in the external healthcare landscape. They serve as the guardian for high standards of compliance, ethics and safety.  This role is organized within a network of experts, and therefore may at any time be performing a variety of medical activities, as needed.

Key Responsibilities for all Medical Directors:

In this role the Medical Directors will be required to perform one or more of the following activities depending upon areas of expertise or assignment to specific activities, molecules, or disease/therapeutic areas:

●             Design, execute, and monitor medical strategies, plans and tactics spanning the lifecycle, including but not limited to:

• clinical data generation design and management
• thought leader interactions
• sponsored and supported trials
• registries, exploratory data analysis
• publications
• medical content creation and review
• scientific exchange/engagement and scientific communications/collaborations
• medical education
• scientific congress planning and support
• evaluate, synthesize, and visualize clinical and economic data and develop written scientific communication
• identify access-related medical issues and opportunities

●             Monitor adverse events reported and partner with medical monitoring team to identify signal vs. noise

●             Identify clinical strategies to mitigate risk for REMS plan [Risk Evaluation and Mitigation Strategies]

●             Provide clinically meaningful perspective for regulatory and other scientific communications

●             Actively participate and contribute to relevant communities of practice

Key Accountabilities for all Medical Directors: 

• Depending upon areas of assignment for specific activities or molecules, disease/therapeutic areas or for the full portfolio, acting as a medical individual for relevant study design and monitoring, data interpretation, medical content development and review, scientific exchange and collaboration, clinical training and insights generation to internal stakeholders and external customers.
• Accountable for implementing strategy through medical tactics, tapping into the network of relevant expertise and insights
• Contribute medical expertise to Genentech work products and coach/mentor others as needed
• Facilitate sharing of information within, across and outside of Medical Affairs to enable medical progress
• Maintaining an in-depth understanding of relevant medical strategy and clinical, patient/caregiver, payer and healthcare/market landscape
• Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions

Qualifications:

•             MD (Board Certified MD within therapeutic area is preferred)

Required Experience:

●             3-10 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience) 

●             Strong academic/teaching background preferred

●             Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development 

●             Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, and medical writing

●             Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) preferred

●             Proven track record of meeting or exceeding objectives and goals

Skills:

•             Strong customer orientation/focus

•             Ability to flex and thrive in an ambiguous environment undergoing transformational change

•             Works well within teams and is effective in collaborating with others internally and externally

•             Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems of moderate complexity and scope e.g. evaluate, interpret and present highly complex data

•             Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points

•             Strong business acumen: knows the industry, key competitors, marketplace factors/dynamics

•             Ability to effectively and efficiently manage multiple priorities

•             Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority

•             Good negotiation skills: can drive discussions and decisions towards desired results

•             Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgement to apply principles to daily activities

•             Strong attention-to-detail

•             Business travel, by air or car, is required for regular internal and external business meetings

#asco19

The Department of Translational Oncology in Genentech Research is seeking a highly motivated Scientist /Senior Scientist to lead a group of up to 5 researchers evaluating novel therapies for cancer. The candidate will explore mechanism, explore rationale combinations, and help uncover biomarkers of response. The successful candidate will work closely with other disciplines within Genentech to drive research stage programs into early clinical development, providing scientific and strategic leadership, and technical management.

We are seeking a PhD, MD, or MD/PhD and post-doctoral training or equivalent experience in pharmacology, oncology, or cell biology is required. A minimum of 5 years of research experience with demonstrated academic achievement, as evidenced by publications in high impact journals, is required for the Scientist; 8-12 years research experience and a minimum of 4 years of prior group management is required for Senior Scientist level. Additional experience in in vivo tumor modeling, in vitro study of primary cells, or the biochemistry of signaling cascades, is encouraged. The candidates should also have strong communication skills and evidence of dedication to translating basic research insights into therapeutics.

#LI-GREDHB2

#AACR19

#asco19

Position Summary

This position reports into the Head of CQC and is primarily responsible for ensuring a robust ECDQMS is in place and serves as the core Quality and Compliance Office (QCO) representative for Global QMS and Medical Compliance Risk activities in Genentech ECD.

Partnering with Clinical Quality Compliance (CQC) and Governance, Standards and Continuous Improvement (GSCI) staff in the ECD Quality Compliance Office, the CQML will provide sound judgment and risk-based rationale to help enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks.

Incumbent will communicate and interface with a host of internal cross-functional partners, both within the QCO, Genentech and other Roche functions; identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance.

The position also provides management, coaching and development of direct reports and/or junior employees and identifies and implements areas of best practice and process improvements and risk mitigation strategies within the group and the broader organization as appropriate/assigned.

The CQML is expected to foster an open and collaborative environment across the global site network and will help ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions

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

• Representing the assigned molecules/products, franchise(s) and overall therapeutic area(s) to the highest ethical and professional standards and in accordance with guidelines, direction and key marketing strategies
• Responding to on- and off-label questions with the highest integrity, compliance and adherence to legal, regulatory and Genentech guidelines, policies & procedures
• Building and cultivating important working relationships internally and externally
• Providing clinical expertise and feedback regarding operational management that effectively and efficiently guides clinical trials, other studies and investigations
• Providing clinical expertise in the development, management and maintenance of clinical and scientific communications, including research, publications, and educational materials, meeting/event presentations and information, etc.
• Actively and effectively participating in various internal and external clinical and scientific education programs, meetings, presentations and other forums; providing in-depth clinical and operational expertise and insights regarding the assigned molecules/products, franchise(s), and overall therapeutic area(s)
• When assigned, identifying and completing special projects
• Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget

Example Responsibilities

Strategy/Planning:

• Work with manager, peers, other partners and stakeholders in the development and alignment of medical plan tactics at the regional and local MSL levels:
• Participating in a variety of cross-functional tactical planning meetings, reviews and discussions
• As assigned, supporting your manager, medical directors, and other peers in gathering information, analyses, research and reporting to support national, regional, and local tactical planning
• With assistance from your manager, using national and regional medical plans for the assigned molecules/products to develop and align the tactical plan for your geography of responsibility
• Providing input to manager regarding travel, budget and other resource requirements to meet or exceed assigned goals and objectives
• Build and cultivate relationships with internal cross-functional partners, such as Franchise Sales, Franchise Marketing, Managed Care & Customer Operations, Thought Leader Services, Pharmaceutical Research and Early Development, Product Development, Clinical Operations, Commercial Operations and other Medical Affairs groups
• Build and cultivate relationships with the local scientific and medical communities, including study site clinical research staff, clinical investigators, physicians, other healthcare professionals, as well as regional thought leaders

Operations:

• As appropriate, support design and development of clinical trials, other studies and investigations
• Support Clinical Operations with Phase III studies, by providing clinical support at investigator sites
• Evaluate, review and propose, when and where appropriate, revisions to protocols in support of the development and/or medical strategies of the assigned product(s). As and when approved, undertake the necessary revisions to protocols, ensuring full compliance with all established procedures and guidelines, as well as appropriate communication to others involved/impacted colleagues and/or external parties
• Work with a host of cross-functional partners to develop plans and tactics for implementation and completion of clinical trials, studies and other investigations. Includes plans for developing and recruiting for patient registries, clinical and scientific communications, publications, clinical and scientific education, advisory boards, clinical and scientific congresses, other conferences and meetings, etc.
• Work with Medical Communications and Publication Planning to develop, disseminate and manage calendars and timelines for clinical and scientific communications, publication plans and other relevant research, data, information and communications for assigned molecules/products

Communication/Other:

• Maintain the highest standards and levels of scientific, clinical and technical expertise in the specific therapeutic area(s) of assignment; reviewing and keeping updated on scientific/medical journals and other relevant publications, attending scientific, clinical, commercial and other key meetings, forums, venues, etc., as well as continuous communication and effective partnering with various Genentech and Roche groups
• As assigned, complete special projects

Required Experience/Knowledge:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following knowledge, skills and abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements. Years of experience listed below can be substituted with equivalent, relevant competency levels.

• Clinical Science Degree
• Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)

Knowledge:

• GCP (Good Clinical Practice) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient
• In-depth knowledge of Phase IV/post-marketing drug development is preferred (knowledge of or experience with Phase I - III drug development is a plus)
• In-depth, relevant therapeutic area knowledge
• Comprehensive understanding of product and safety profiles
• Demonstrable knowledge of medical aspects of FDA regulations

Experience:

• 4 or more years' related work experience (academic, research, clinician, consulting or industry experience)
• Experience as a field medical science liaison is a plus
• 2 or more years’ clinical trial experience (either in industry or in another, related setting) is preferred
• 2 years' experience in relevant therapeutic experience

Skills/Abilities:

• Proven track record of meeting or exceeding objectives and goals
• Outstanding attention-to-detail
• Good business acumen; has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. research, development, clinical operations, biostatistics, regulatory, commercial, etc.
• Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
• Outstanding self-presentation skills
• Demonstrable influencing and professional presentation skills
• Strong communication skills, both written and verbal; includes very good listening skills and an open attitude and acceptance to being
• Strong communication skills, both written and verbal; includes very good listening skills and an open attitude and acceptance to being coached
• Strong teamwork orientation
• Proficient computer skills, including Microsoft Word, PowerPoint, and Excel
• 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
• Candidate selected for this role must reside in the assigned territory of PA, WV, VA, DE, MD, DC.

The Medical Director or Senior Medical Director at Genentech puts patients and science at the center of all actions. They drive and guide medical strategy and tactics aimed at maximizing medical progress. They collaborate to drive timely data generation and dissemination. They are expected to maintain an in-depth understanding of the medical strategy and relevant clinical and payer issues, while ensuring Genentech's partners understand key trends and shifts in the external healthcare landscape. In addition, they lead a team of 8-10 individual contributors.     They act as a coach and catalyst for the development of these team members. They understand and evaluate their team and organization’s opportunities and constraints and build capabilities with an enterprise mindset. They serve as the guardian for high standards of compliance, ethics and safety.  

 Key Responsibilities

● Design, execute, and monitor medical strategies, plans and tactics spanning the lifecycle, including but not limited to:

• clinical data generation design and management
• thought leader interactions o sponsored and supported trials
• registries, exploratory data analysis
• publications o medical content creation and review
• scientific exchange/engagement and scientific communications/collaborations
• medical education
• scientific congress planning and support
• evaluate, synthesize, and visualize clinical and economic data and develop written scientific communication
• identify access-related medical issues and opportunities

● Monitor adverse events reported and partner with medical monitoring team to identify signal vs. noise

● Identify clinical strategies to mitigate risk for REMS plan [Risk Evaluation and Mitigation Strategies]

● Provide clinically meaningful perspective for regulatory and other scientific communications

● Actively participate and contribute to relevant communities of practice

Key Accountabilities

● Depending upon areas of assignment for specific activities or molecules, disease/therapeutic areas or for the full portfolio, acting as a medical individual for relevant study design and monitoring, data interpretation, medical content development and review, scientific exchange and collaboration, clinical training and insights generation to internal stakeholders and external customers.

● Accountable for implementing strategy through medical tactics, tapping into the network of relevant expertise and insights

● Contribute medical expertise to Genentech work products and coach/mentor others as needed

● Facilitate sharing of information within, across and outside of Medical Affairs to enable medical progress

● Maintaining an in-depth understanding of relevant medical strategy and clinical, patient/caregiver, payer and healthcare/market landscape

● Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions

● Focus on being a visionary, coach, catalyst, & architect; provide strategic technical and/or functional mentorship and coaching to your teams

● Ensure fluidity and flexibility of people across activities within the network including suggesting appropriate resources for work products based on capacity, interests, and needs in conjunction with other Team Lead peers and the Network Lead

● Identify necessary capabilities and resources needed within the network to support work products, initiatives and projects in conjunction with other Team Lead peers and the Network Lead

● Identify and address training and development needs of your direct reports

● Strengthen leadership capability in the organization in line with the needs of USMA/Genentech strategies

Key Competencies:

• Strategic Agility: Strong ability to translate vision into a direction that adds distinct value to Genentech and builds competitive advantage
• Building and Leading Teams: Excellent ability to lead and advance effective team performance across the business
• Business Knowledge: Superior ability to integrate functional knowledge of BioOncology Medical Affairs and Oncology therapeutic area with a broader business perspective and appreciation for our markets and the overall biotech industry

Qualifications

• Be medically qualified (MD) with an area of advanced oncology specialization 

Experience:

● 5-10 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience)

● Strong academic/teaching background preferred

● Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development

● Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, and medical writing

● Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) preferred

● Proven track record of meeting or exceeding objectives and goals

● Previous people management experience is required; Demonstrated ability to mentor and develop emerging leaders

● Demonstrated ability to positively and strategically influence employees at all levels

Skills:

● Strong customer orientation/focus

● Ability to flex and thrive in an ambiguous environment undergoing transformational change

● Servant leadership

● Ability to flex and thrive in an ambiguous environment undergoing transformational change

● Works well within teams and is effective in collaborating with others internally and externally

● Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems of moderate complexity and scope e.g. evaluate, interpret and present highly complex data

● Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points

● Strong business acumen: knows the industry, key competitors, marketplace factors/dynamics

● Ability to effectively and efficiently manage multiple priorities

● Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority

● Good negotiation skills: can drive discussions and decisions towards desired results

● Ability to flex and thrive in an ambiguous environment undergoing transformational change

● Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities

● Proven abilities to effectively and efficiently manage multiple priorities, goals, objectives and projects through to successful conclusion

● Strong financial acumen: proven abilities for effective planning, development and oversight of resources

● Business travel, by air or car, is required for regular internal and external business meetings

#asco19

Job Responsibilities ·

Dismantle, adjust, repair and assemble equipment according to layout plans, blueprints, operating or repair manuals, rough sketches or drawings. · Rebuild manufacturing equipment as needed. · Use test and diagnostic equipment to perform checkouts. · Perform equipment modifications as directed by manufacturing engineers. · Adhere to proper documentation procedures (manufacturing tickets and stand operating procedures) · Maintain clean room aseptic processing qualification. · Set-up production equipment for manufacturing, and continually refine and quantify set up parameters. · Provide training to technicians. · Participate in shift exchange meeting, and confirm assignments with Operations Supervisor. · Respond to emergency call-in when regularly scheduled backup personnel are not available. · Clean, prepare, and operate filling equipment. Participate in aseptic processing and filling and pharmaceutical product. · Participate in the implementation of 5S within Clinical Filling. · Complete and review production documents in real time. · Participate in on-going training programs to enhance technical proficiency. · Adhere to manufacturing safety regulations. · Comply with current Good Manufacturing Practices.

This is a temporary assignment. The individual in this role will be employed by a third party, not by Genentech.

The Position

Genentech’s Early Clinical Development (ECD) department is seeking an Artificial Intelligence (AI) Scientist reporting to the AI Team Lead. The ECD AI group impacts Clinical Operations in trial design, planning and predictive tools. The role will require cross-functional interactions with early research in discovery chemistry (CADD) and DMPK. The AI Scientist will act as the Scientific Advisor and be required to both establish and apply new AI methods to specific problem domains within those functions.

AI Scientist will develop and implement novel mathematical and algorithmic techniques for deep learning applications. These can be widely applicable or highly project specific. The main focus for this positions research direction in quantifying and developing methods for effective transfer learning in clinical, imaging and other domains for the application to new small sample size studies. The output will be new tooling, algorithms and novel publications which are effective in a prospective manner.

Responsibilities

• Lead key AI pilots to ensure successful completion and develop plans to integrate capabilities into the normal early clinical development process
• Research into the construction of transfer learning metrics for imaging, IHC and clinical neural networks
• Develop new and novel models using clinical data and integration of multiple sub networks
• Provide mathematical support and guidance to other AI team members and scientific stakeholders and collaborators
• Possess in-depth knowledge of multiple real-world data assets and share information about these data to business partners and the ECDi team.

Qualifications

• Experience (3+ years) developing machine learning algorithms for clinical domain, including the development and construction of metrics for machine learning
• Proven ability to represent data in medical informatics using ICD. CPT, LOINC, SNOMED, and RxNorm
• Strong programming skills with Python including iPython, Spark, MatplotLib
• Strong analytical and problem-solving skills
• Excellent oral and written communication skills
• Ability to lead cross functional multi-disciplinary teams
• Able to work in teams and collaborate with others to solve the most challenging business problems
• Tensorflow, PyTorch, and PIL are a plus
• 2+ years deep learning experience

Education

• PhD in Mathematics or Computer Science, Postdoctoral training required.

#LI-gREDKM2

The Position

Genentech’s Early Clinical Development (ECD) department is seeking an Artificial Intelligence (AI) Engineer reporting to the AI Team Lead. The ECD AI group breaks new ground in Clinical Science, Deep Learning Discoveries and Novel Trial Design, planning and predictive tools. The role will require cross-functional interactions and collaborations with early research in discovery chemistry (CADD) and DMPK. The AI Engineer will act as a key advisor and influencer and be required to both establish and apply new AI methods to specific problem domains within various functions.

The AI Engineer will primarily be responsible for the development and the deployment of

deep learning methods in early research and early clinical development.

Responsibilities

• Lead key AI pilots to ensure successful completion and develop plans to integrate capabilities into the normal early clinical development process
• Development of new and novel Deep learning methods for reinforcement, learning, knowledge transfer and generative methods
• Application of deep learning methods to problems and support in clinical studies as well as early discovery and research
• Develop the software tools and library for application of deep learning methods, and train other colleagues within gRED and cross-Roche to develop and use the tools in their applications
• Development of deep learning methods for adverse event prediction
• Possess in-depth knowledge of multiple real-world data assets and share information about these data to business partners and the ECDi team.

Qualifications

• Experience (7+ years) and a proven track record in software engineering, repositories and track record of contribution to deep learning projects
• Python, Tensorflow, Scikit Learn, C++ PyTorch, DeepChem,
• Strong analytical and problem-solving skills
• Excellent oral and written communication skills
• Ability to lead cross functional multi-disciplinary teams
• Able to work in teams and collaborate with others to solve the most challenging business problems
• Deep Chem, RDKit, SPARQL, and SQL are a plus

Education

• MS or Phd in Artificial Intelligence and machine learning with particular emphasis on molecular property prediction

#LI-gREDKM2

Mission

Our Product Development Informatics (PDIX) organization is co-creating a better future for patients through technology and information. We are an agile organization that brings together great people who are passionate about technology innovation, and who thrive in dynamic, cross-functional, and mission-driven teams.

Our agile organization is made up of structures called Networks and Chapters. “Networks” comprise business domain and technical experts aligned closely with our Product Development business partners to develop and deliver technology-enabled business strategy. Our “Chapters” are centers of expertise of deeply skilled people deployed for maximum impact. These teams work together to deliver outstanding value to our business, patients and customers.

You will lead the Product and Service Management Chapter for PDIX.  You will develop an expert team of service managers who will work closely with product managers and IT Business Partners to ensure products (ecosystem of applications) and related IT assets are maintained and operate 24x7.  You will ensure the service managers are assigned to squads within Networks. You will partner with the PDIX Network Heads and other Chapter Heads to help develop product operations best practices. You will translate the developments in your domain into strategy within the chapter and make sure it is well transferred to all chapter sections and ensure chapter section alignment. As people manager you will help chapter section leads on their personal development.

What you’ll be working on

• Develops Service Management Center of Excellence (CoE) ensuring the team owns all aspects of service delivery, governance and performance

• Ensures the team is trained and accountable for continuous improvement and operational excellence

• Ensures timely and consistent monitoring of product performance across PD

• Develops and implements a “health” dashboard to create transparency to business and accurate assessment of impact to the business

• Incorporates DevOps appropriately in collaboration with Architecture Chapter Head and team

• Coaches Chapter Section Leads and oversees their performance management

• Coordinates with other Chapter Heads of equal specialty

• Supports Chapter Head in Chapter development and sharing of best practices

• Defines chapter structure and governance at organization unit level

• May take Chapter Head role in a temporary and rotation basis

The ideal candidate:

• Has deep knowledge of PD systems landscape, GxP compliance, and service management

• Demonstrated experience effectively running and maintaining products and IT services

• Strong understanding of ITIL and DevOps

• Experience in systems design and implementation from using Agile methodology

• Exhibits the behaviors of a Lean-Agile Leader with a Lean-Agile Mindset

• Exhibits servant leadership behavior

• Have a keen IT market focus: you are passionate about major trends in the way of working for the specific discipline

As part of the Global Operations team we are looking for an infrastructure engineer based in South San Francisco for our High Performance Computing (HPC) environment. You will manage agile computing environments in several locations to support our Research Partners on supporting the relevant infrastructure components to achieve agility and performance. This includes installing, configuring, administering, and fine-tuning our High Performance Computing environment and related infrastructure components across the organization in a timely, cost-effective and efficient manner.

Responsibilities:

• Assist on the design of the new HPC infrastructure and evolution of the current environments.

• Ensures installation, configuration and operation of the environments to achieve the performance and agility of the various applications supported (in the range of several hundreds).

• Contributes to the concept, planning and execution of projects.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications:

• Bachelor’s degree in Computer Science or equivalent work experience

• Must have Linux Administration and scripting experience (other programming language a plus)

• Senior level technical operational skills, such as troubleshooting, capacity planning, and root cause analysis

• 7+ years of Linux System Administration and work related experience

• 3 + years of experience and knowledge of HPC preferred

• DevOps experience a plus (Puppet, Jenkins)

• Excellent customer orientation and delivery focus with good end user perspective

• GPFS basics

• Configuration management (GIT/Stash, Puppet, and basic Bright knowledge)

• Experience working in a fast changing environments where solutions are deployed and retired at high pace

• Demonstrated problem solving skills

• Good communication and interpersonal skills

• Ability to work effectively alone or within a team, including virtual teams

• Proactivity, with a clear ability to think beyond boundaries, take controlled risks and assume responsibilities

• Understanding of Computer Systems Validation and ITIL concepts, preferred

• Active open source contributor

• Working experience in pharmaceutical or scientific/research sector is a plus

• Experience working in a global organization, working in an international and multicultural environment considered a plus

Basic knowledge in:

• Dockers: Mesos/Marathon, DC-OS

• Monitoring: Ganglia, Grafana, ELK, Influxdb

• Provisioning: Katello/ Foreman, Jenkins

• Network: Mellanox

Advanced knowledge/consideration:

• More than 5 years of HPC experience (High Performance Computing)

• Monitoring: Ganglia, Grafana, ELK, Influxdb

• Provisioning: Katello/ Foreman, Jenkins:

• Network: Mellanox

• Dockers: Mesos/Marathon, DC-OS

The Position

This role is responsible for improving the desktop user experience for 30k employees & contractors through enabling automation and self-service capabilities.  Desktop systems will include mostly Windows 10 and MacOS, as well as some Linux systems. You will be responsible for the prioritization of opportunities based on their complexity vs benefit.  This is a hands-on role and in addition, will establish the standards and baselines used by all desktop service teams. 

This position reports to the Head of User Services - Onsite Support for Genentech and is based in South San Francisco, CA and is not eligible for relocation.

Responsibilities

• Act as a lead influencer of innovation, optimization, automation, and process improvement within the User Services organization and beyond
• Use data, feedback, and ingenuity to drive better service, products, and processes
• -Analyze, design, develop, document, and implement complex solutions for end user computing systems
• -Apply emerging technologies & information to optimize performance
• Design, Develop, Deploy, and Document PowerShell scripts and modules to automate repetitive tasks related to desktop support.
• Review and Approve scripts and modules developed by other team members.
• Establish standard methods for reporting, monitoring, and error handling within scripts
• Maintain a code repository for all scripts and applications.
• Provide Code Snippets for team members for use with common activities.
• Update and improve existing support procedures within End User services
• Develop and intake process for automation requests and prioritize based on the business impact and level of effort needed
• Proactively identify, investigate, resolve, and prevent common technical incidents and problems
• Develop and test customized solutions to meet specific business needs
• Proactively incorporate technologies, capabilities, and offerings into strategies, plans, programs and other offerings 
• Utilize desktop tools such as NexThink to provide proactive user activities and prevent productivity impacts
• Suggest, lead, and contribute to innovative solutions, proof of concepts, pilots, and new support channels
• Introduce, and contribute to, longer-range strategies, objectives, and plans
• Create and maintain a seamless end-user experience while overseeing & prioritizing multiple projects, requests, tasks, and recurring work
• Develop technical solutions to a wide range of difficult problems - solutions should be imaginative, thorough, practicable, and consistent with organizational objectives.
• Participate in various projects and deliver assigned milestones
• Provide exceptional customer service to customers, vendors, and key stakeholders
• Establish a collaborative network of resources (within and beyond User Services)
• Mentor, train, and develop peers & junior technicians within the organization
• Assist with pilot and platform testing, deployments, and configurations
• Adhere to incident management, request fulfillment, and knowledge management processes while meeting/exceeding all established KPIs, SLAs, and metric requirements
• Bridging people and technology to ensure an outstanding, proactive, and quality user experience
• Develop ad-hoc scripts and utilities to automate tasks.
• Perform tool testing, validation, and documentation.

Requirements

• Minimum 4+ years of experience as an End User Computing/Desktop Automator and 2+ years in a Desktop Support / technical troubleshooting role
• Bachelor’s Degree in a relevant field is a plus
• Detailed understanding of, and expert experience with: automation, scripting languages (PowerShell, etc.), data analysis, digital experience management, deployments, cloud-based platforms, information security, SCCM, desktop infrastructure, software packaging and distribution, patch management, digital workplace environments, etc.
• Has acted as the technical lead for multiple implementations, upgrades, deployments and/or migrations & has experience supporting virtual environments
• Comprehensive understanding of Active Directory & Group Policy Management
• Advanced technical experience supporting Windows OS, Macintosh OSX, mobility platforms, UNIX, Google suite (gMail, gCalendar, gDrive), etc.
• Relevant Certifications preferred
• Well-versed in ITIL core processes:  Incident Management (IM), Request Management (RM), and Knowledge Management (KM)
• Experience with Machine Learning & Artificial Intelligence is a plus
• Experience with Service Now is a plus
• Business travel may occasionally be required

Knowledge, Skills & Abilities:

• Strategic agility – link individual accountabilities with the mission of the organization; focus on activities that add the most value 
• Able to represent manager in meetings and make decisions related to areas of subject matter expertise
• Outstanding customer service, business partnering, and interpersonal skills
• Communicates clearly with technical and non-technical audiences, both verbally and written
• Strong organizational and multi-tasking skills, along with the ability to prioritize tasks among many competing requests
• Professional attitude and demeanor
• Strong analytical skills for effective troubleshooting and problem solving
• Able to organize and frame appropriate timelines to meet delivery goals
• Ability to work in a team environment or independently / autonomously
• Familiar with Workflow and Orchestration tools

• This person will provide timely, accurate, and effective Executive Administration support to Sr. Management and/or their direct reports, contributing to organizational and corporate goals.
• Able to make independent decisions regarding calendar priorities of those you support to reduce conflicts and accommodate high priority commitments.
• Will hold lead and/or mentor responsibilities over some administrative staff.
• General office responsibilities include: maintain multiple calendars; plan, schedule and coordinate teleconferences, travel, onsite/offsite meetings; process payments and expense reports and utilize PC and Mac software applications at the intermediate to advanced level.
• Maintains compliance and confidentiality.
• Address problems and develop practical, thorough, and creative solutions without relying on precedent or supervisory review.
• Exercise independent judgment and discretion with sensitive/confidential and proprietary information. 
• May take action independent of supervisor.
• Partners with one’s supervisor and other staff to maximize the efficiency of the work group.
• Participates, plans, coordinates and prioritizes work within or across departments by providing project leadership, direction, training and assistance to others.
• May lead special projects.
• Act as a Mentor or resource to other Administrative Professionals and departmental staff throughout the team and Business Partner groups.
• Understand and troubleshoot from a broader prospective and anticipate the impact of office administration problems and solutions on other areas.
• Independently creates and delivers presentations based on general instructions; delivers to group.

Who you are:

• You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications:

• High school diploma and minimum 7-10 years as of related experience that includes at least 4 years supporting a senior or executive manager, or an equivalent combination of education and experience.
• BA/BS degree or equivalent industry experience or training preferred.
• Highly skilled in interpersonal communications and writing, Including persuasion and influence.
• Ability to quickly gain extensive knowledge of organization being supported. 
• Handles interpersonal interactions at all levels and manages highly sensitive interpersonal situations and information.
• Leadership skills through experience or other sources desired. Ability to respond to request for information during core business hours of 8:00am-5:00pm 5 days a week or weekends to support Senior/Executive Management.
• Ability to adjust work schedule beyond the core business hours of 8:00am-5:00pm to support the operations
• Ability to stand or sit for at least 6 hours each day
• Requires a significant amount of keying and mousing. Ability to accommodate extended periods of computer use to meet business operations.