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Date Job Title Job Level Location
2/26/21 Intern - Corporate Groups - Occupational Hygiene Entry Level South San Francisco, California

Start Date: May 25, 2021 (Summer 2021)

Work Hours: 40 hours per week 

Length of Assignment: 3 months

Education Level: Bachelor's (must be enrolled in or completed their 2nd year) and above

Preferred Majors/Disciplines: Chemical Engineering & Biochemical Engineering, Mechanical Engineering.

Given the current uncertainty of the global pandemic and work from home situation for 2021, this internship is currently planned to be virtual with the option for interns to work remotely from within the U.S. Borders. We will keep candidates informed if this changes. 

This internship position is in the SSF Environmental, Safety, and Health (Site EHS) group, which supports SSF and Dixon groups such as Manufacturing. Process Technology, Research and Development, and Site-related support organization. The Occupational Group program Management Group works in collaboration with Manufacturing and Pilot Plant Operations, and SSF Site support groups to ensure compliance with EHS regulations and Roche SHE Directives,  and assess and reduce the impact from identified hazards. We are responsible for programs that impact the client groups, and supply technical consulting and support to the customer groups.

Job Description/Responsibilities

You will need to provide technical judgment with Asphyxiant Gas handling, design guidance document, and procedure as part of a team responsible for delivering safety engineering guidance, procedures, and inventory use. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.

Specific responsibilities in this position will include:

  • Assessing the present operation, and collaborate with the department owner to determine if the current operation is a risk, and makes recommendations to lower the risk level.

  • Creating new, and revision existing procedures that support the asphyxiant gas program in collaboration with technical writing staff for the Site, and Corporate Engineering.

  • Summarization of projects highlighting the accomplishments and poster/oral presentation at staff/department meetings.

Requirements/Qualifications

  • Candidate must possess good problem solving, interpersonal, communication, and team skills.

  • Technical Writing

  • Candidate with familiarity with Google applications

2/26/21 Intern - Corporate Groups - Facilities Operations & Maintenance Entry Level South San Francisco, California

Start Date: May 18, 2021 (Summer 2021)

Work Hours: 40 hours per week 

Length of Assignment: 1 Year

Education Level: Bachelor's (Must be entering 3rd or 4th year of college program)

Preferred Majors/Disciplines: Engineering or related field 

Given the current uncertainty of the global pandemic and work from home situation for 2021, this internship is currently planned to be virtual with the option for interns to work remotely from within the U.S. Borders. We will keep candidates informed if this changes. 

Due to the ever changing situation concerning the COVID-19 global pandemic, for our summer 2021 internship program we will only consider international candidates who are currently in the US and will remain in the US for the duration of the internship.

FOM provides reliable, cost-effective operation and maintenance to buildings, facilities, laboratories, utilities and equipment within the SSF Site Service organization. FOM is fully committed to quality and dedicated to continuous improvement through innovation and providing technical leadership in developing solutions to meet the needs of a growing campus in support of Commercial, Clinical Product Manufacturing and R&D operations.

Job Description/Responsibilities

In this position, you will work with Campus Managers and Facility Maintenance organization along with subject matter experts in FOM on one or more projects related to the following:

 

  • Update engineering drawings,

  • Standardize FDH (Facilities Data Historian) alarm descriptions,

  • Assign equipment alarm response instructions in FDH,

  • Improve work order efficiency through Mobile Maintenance Rounds.



Specific responsibilities for this position may include:

  • Adherence to all applicable regulatory compliance and safety requirements such as, cGMPs, SOPs

  • Ability to utilize (Microsoft Office Suite and Google Docs)).

  • Implementation of projects with a focus on equipment and utility system improvements.

  • Creation and revision of documents in collaboration with other functional groups.

  • Summarizing projects, highlighting the accomplishments in a poster/oral presentation at staff/department meetings.

Requirements/Qualifications

  • Must be enrolled student (BS or higher in Engineering or related field),

  • Must be entering 3rd or 4th year of college program.

  • Knowledge overview of building infrastructure and support systems including utility distribution systems, gases, HVAC or similar systems.

  • Must be independent worker and self-starter and motivated to work with a team

  • Candidate must have good organizational, verbal and written communication skills.

  • Possess an intuitive sense for working safely in a potentially risky environment.

  • Ability to read and understand system drawings and P&ID`s associated with utility systems.

  • Computer Skills: CMMS(SAP), Microsoft Office Suite

     

2/26/21 Intern- Research and Early Development- Drug Metabolism and Pharmacokinetic Metabolism Entry Level South San Francisco, California

Start Date: Summer 2021

Work Hours: 40 hours per week 

Length of Assignment: 3 months

Education Level: Master's, PhD (pursuing PhD, not completed)

Preferred Majors/Disciplines: Cheminformatics, informatics, chemistry, pharmaceutical sciences

Given the current uncertainty of the global pandemic and work from home situation for 2021, this internship is currently planned to be virtual with the option for interns to work remotely from within the U.S. Borders. We will keep candidates informed if this changes. 

Additionally, our summer 2021 internship program will only consider international candidates who are currently in the US and will remain in the US for the duration of the internship.

The mission of the Drug Metabolism and Pharmacokinetics (DMPK) group is to enable the discovery, selection, development, and commercialization of safe and effective medicines for significant unmet medical needs by elucidating the absorption, distribution, metabolism, elimination and pharmacokinetic properties of small molecule drug candidates. We accomplish this through application of state-of-the-art technologies and sciences of bioanalysis, drug metabolism and disposition, innovative thinking, effective collaboration and teamwork. We commit ourselves to high standards of ethics, integrity, scientific excellence, diversity, trust and respect for people.

Job Description/Responsibilities

  • Explore the feasibility of using different machine learning (including both traditional machine learning and deep learning) ADME models to detect potential experimental outliers and enable assay owners to make pre- and post-experiment decisions. 

  • Validate the approach retrospectively via data mining and prospectively by proposing retesting in collaboration with experimental scientists.

  • Characterize overall trends and underlying drivers leading to non-specific binding and other experimental artifacts

Requirements/Qualifications

  • Required: hands on expertise in machine learning

  • Desirable: cheminformatics, data analysis, informatics, organic chemistry.

2/26/21 Research/Sr. Research Associate - Cell Therapy Process Development Individual contributor South San Francisco, California

Role:

Genentech is seeking an exceptional, highly motivated, and talented cell biologist to support the cell therapy process development group, aiming to derive immune cells from induced pluripotent stem cells (iPSCs) for cell therapy applications. In this role, the successful candidate will work with internal and external colleagues to support pre-clinical and clinical process development and product characterization. The successful applicant will have a background in stem cell biology, iPSC maintenance and differentiation, flow cytometry, and molecular biology. Knowledge of the hematopoietic system and immunology is preferred. 

Responsibilities:

  • iPSC culture and maintenance. 

  • Differentiation of iPSCs into mature and functional immune cells.

  • Assess iPSC-derived cell products by cell-type-specific marker expression & functional characterization.

  • Interact with research and development teams to troubleshoot existing differentiation methods.

  • Evaluate platform technologies and instrumentation for internal use or potential outsourcing opportunities.

  • Ability to work with novel cell culture, iPSC reprogramming, and next-generation differentiation protocols to increase yield and process robustness.

  • Provide high-quality, specialized iPSC-derived cells to other scientists working on assay development and quality control.

  • Maintain accurate records of research and deliver scientific presentations and reports internally to interdisciplinary teams.

  • Occasional weekend and/or evening hours as necessary

 

Qualifications:

  • B.S./M.S. + 1-2 years of relevant experience in cell biology, stem cell biology, molecular biology, immunology, bioengineering, or a related discipline. 

  • Extensive hands-on mammalian cell culture experience is required.

  • Experience with multi-color flow cytometry.   

  • Experience with mammalian cell culture and culturing primary cells, ESCs, iPSCs, in-vitro differentiation of ESC/iPSCs. 3D culture and differentiation of iPSCs is a plus.

  • Hands-on experience with iPSC differentiation to CD34+ hematopoietic progenitor cells or T cells is preferred.

  • Experience in process development, scaling, automation in a cell culture/production environment is a plus. 

  •  Excellent teamwork, oral/written communication, time management, analytical, critical thinking, and organizational skills.

  • High scientific integrity, committed to ethics and scientific rigor.

#LI-DW1

#PTD

#PTCareers





 

2/26/21 Technical Development Research Assistant/Associate Individual contributor South San Francisco, California

Research Associate – Technical Development

Job Summary:

Position is within Analytical Operations providing analytical support to Pharma Technical Development in GMP and R&D environments. 

Job Responsibilities:

  • Perform UHPLC, CE and LC-MS assays and data processing
  • Prepare assay reagents
  • Maintain instruments
  • Troubleshoot assays 
  • Handle biological and chemical reagents
  • Collaborate with colleagues within and outside of the department

Job Requirements:

  • Bachelor's degree in biological or chemical sciences, or related discipline
  • 2 to 4+ years of relevant lab experience
  • Hands-on experience with (U)HPLCs  
  • Familiarity with analytical techniques such as CE, iCIEF, and LC-MS is highly desirable
  • Knowledge of GMP compliance, HPLC software, computer programming, and intermediate experience with EXCEL is desirable
  • Strong communication skills, both written and oral, with the ability to present work in a formal setting 
  • Self-motivated, highly organized, able to work independently with minimal supervision, and able to multi-task
  • Strong attention to detail
2/26/21 Senior Manager, Patient & Customer Experience Design Individual contributor South San Francisco, California

At Genentech, our mission is to deliver more life to every patient today and fuel tomorrow’s breakthroughs. The Patient & Customer Experience Design Team brings that mission to life through development of critical patient and customer solutions that deliver seamless, consistent and meaningful experiences.  This individual will lead discovery and design phases of large-scale projects focused on improving patient and customer experience.  Additionally, they play a critical role in ensuring a seamless transition from discovery to implementation, helping define pilots and monitor launch success by capturing end user feedback around novel solutions and services. They will also enhance and champion experience design capabilities internally.

The Senior Manager, Patient & Customer Experience Design is an individual contributor role reporting directly into the Experience Design Team Lead while working across a matrixed organization. This is a continuously evolving environment, high-growth opportunity where you can have an immediate impact within a growing team. The ideal candidate will need strong human-centered design expertise, solid cross-functional leadership skills and prides himself/herself on being visionary, innovative and driving new ways of working.   This could not be a more exciting time to join this team - as a design strategist you’ll join a cross-disciplinary team to create world-class experiences in service of improving patient outcomes.

Key Accountabilities

  • Leads and drives vision and strategy with all stakeholders for key large-scale experience design initiatives
  • Champions design thinking and human centered design
  • Designs solutions that provide seamless, consistent and meaningful patient and customer experiences
  • Drives development of service blueprint that serves as the foundation for all subsequent design, development, and implementation efforts and informs overall roadmap
  • Provides strategic thought partnership as a consultant on experience challenges to partners across Genentech
  • Collaborates with VoC service team to ensure compelling opportunities surfaced through direct patient and customer feedback feed into backlog of design initiatives
  • Continually builds industry knowledge and experience design subject matter expertise and connects internal stakeholders with best-in-class tools, frameworks, learnings and case studies

Qualifications

  • Bachelor's degree required, ideally in experience design, industrial design or service design; graduate level degree in Product Design, Interaction Design, Industrial Design, or Psychology preferred
  • 10-12+ years of experience across varying roles with significant time in  Customer Experience Design, Design Strategy, Design Thinking, or Behavioral Design
  • Design thinking is in your DNA. It isn’t just a process to you, it’s just the way you work. You have a track record of scrappy (not crappy!) prototyping, piloting, & experimenting to get to the right user experience
  • You’re a natural teacher and have a knack for distilling the complex into a way that people understand. And you’re never satisfied with just reaching the head, you want to stir the heart too
  • You’re empathetic, curious, and innovative. You understand both humans and technology, and you’re interested in how they interact
  • Proven ability to turn strategic intent into meaningful world-class experiences for both internal and external audiences
  • Ability to communicate complex concepts simply, and create high quality, simple, visually compelling presentations
  • Strong interpersonal skills to collaborate with a diverse set of team members and stakeholders across different levels of the organization
  • Proven ability to obtain, analyze and use inforåmation for effective decision-making
  • Proven ability to work in a diverse and ambiguous environment

Competencies

  • Strategic Agility
  • Teamwork and Collaboration
  • Communication
  • Achieving Results
  • Technical and Business Expertise

#LI-KG1

#PCX

2/26/21 Ophthalmology Clinical Research Fellow Entry Level South San Francisco, California

Location: South San Francisco

Start Date: Fall 2020

Term: 1 year

Hours: 40 hours/week

Please only apply to this job posting if you are interested in the Ophthalmology department.

Job Description:

Genentech’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase Ib – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. 

Delivering superior clinical research requires close collaboration between academic and industry professionals.  The Genentech Clinical Research Fellowship program entails a collaboration between academic institutions and Roche-Genentech, offering experienced MD fellows interested in a career in clinical research, a one-year experience in this area. 

Roche, a world leader in clinical research, has generated large clinical databases from multiple randomized clinical trials and registries. Your own exceptional talents can help take us further, building on this data while giving you the opportunities you're seeking to propel your career.

Diverse candidates are encouraged to apply. 

Responsibilities:

These would mainly consist of, but are not limited to:

 Clinical Development Team  - Ophthalmology 

  • Analyzes and interprets data from clinical studies

  • Is a member of the relevant Clinical Science Team (CST)

  • Participates as an ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team 

  • Participates in strategic meetings (at study or project level) in order to gain a deeper understanding of the complexities and challenges of drug development

  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic area(s) of assignment, providing clinical expertise in the disease area for cross functional teams

  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and Therapeutic Area Experts (TAEs), as well as multidisciplinary internal groups, including other groups in PD or gRED, research, biomarkers development, regulatory, business development, commercial operations, legal, etc. providing clinical support across all relevant studies and programs 

  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

Clinical Fellowship Project 

  • Secures a mentor from their academic institution (if applicable)

  • Designs clinical research projects in his/her area of interest 

  • Partners with Biostatistics and Programming in order to generate the necessary analyses plans for the research projects

  • Is responsible for generation of abstracts or manuscripts for publication derived from the clinical research findings and presents the research findings at key conferences and other specialty meetings

  • Participates in relevant internal and external Genentech meetings related to the projects

  • Completes the research projects within the one-year program

  • On an ongoing basis and at the conclusion of their one-year fellowship, presents his/her data to an internal peer review group

Education and Training

  • With support of the Genentech mentor, develops an educational project plan to improve his/her knowledge base on Drug Development

  • Participates in regular therapeutic area meetings on a variety of clinical topics

  • Participates in additional relevant Roche-Genentech training opportunities that arise throughout the year

  • Completes the Genentech/Roche Standard Operating Procedure training modules

SELECTION CRITERIA:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following 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.

QUALIFICATIONS & EXPERIENCE:

  • Experienced MD fellows, in their fellowship stage of medical subspecialty training, in major academic institutions

  • Exceptional senior residents might also be considered as fellowship candidates

  • Experience in generating publications and manuscripts‒ own publications track record is a plus

  • Teaching background is a plus

  • Fellows and their academic institutions must agree to uphold Roche-Genentech confidentiality and intellectual property contracts

  • Fellows must be able to work at Genentech headquarters in South San Francisco (SSF) or be able to attend remote working calls during SSF hours. 

  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance 

 

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values

  • Outstanding attention-to-detail

  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

  • Good interpersonal, verbal communication and influencing skills; can influence without authority

  • Strong written communication skills

  • Good presentation skills; is comfortable and effective when presenting to others, internally or externally

  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

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

2/26/21 Immunology Clinical Research Fellow Entry Level South San Francisco, California

Location: South San Francisco

Start Date: June 2021

Term: 1 year

Hours: 40 hours/week

Please only apply to this job posting if you are interested in the Immunology and other programs department.



GENERAL POSITION SUMMARY:

Genentech’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase Ib – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.  

Delivering superior clinical research requires close collaboration between academic and industry professionals.  The Genentech Clinical Research Fellowship program entails a collaboration between academic institutions and Roche-Genentech, offering experienced MD fellows interested in a career in clinical research, a one-year experience in this area. 

Roche, a world leader in clinical research, has generated large clinical databases from multiple randomized clinical trials and registries. Your own exceptional talents can help take us further, building on this data while giving you the opportunities you're seeking to propel your career.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES 

These would mainly consist of, but are not limited to:

 

1. Clinical Development Team  

  • Is involved in the design, set-up and execution of Phase I through Phase III clinical trials

  • Analyzes and interprets data from clinical studies, including biomarkers development, and analysis of patients’ samples

  • Is a member of the relevant Clinical Science Team (CST), participating in clinical strategy 

  • Participates as a core or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team 

  • Participates in strategic meetings (at study or project level) in order to gain a deeper understanding of the complexities and challenges of drug development

  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic area(s) of assignment, providing clinical expertise in the disease area for cross functional teams

  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and Therapeutic Area Experts (TAEs), as well as multidisciplinary internal groups, including other groups in PD or gRED, research, biomarkers development, regulatory, business development, commercial operations, legal, etc. providing clinical support across all relevant studies and programs 

  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

     

2. Clinical Fellowship Project 

  • Secures a mentor from their academic institution (if applicable)

  • Designs clinical research projects in his/her area of interest 

  • Partners with Biostatistics and Programming in order to generate the necessary analyses plans for the research projects

  • Is responsible for generation of abstracts or manuscripts for publication derived from the clinical research findings and presents the research findings at key conferences and other specialty meetings

  • Participates in relevant internal and external Roche meetings related to the projects

  • Completes the research projects within the one-year program

  • On an ongoing basis and at the conclusion of their one-year fellowship, presents his/her data to an internal peer review group

     

3. Education and Training

  • With support of the Genentech mentor, develops an educational project plan to improve his/her knowledge base on Drug Development

  • Participates in regular therapeutic area meetings on a variety of clinical topics

  • Participates in additional relevant Roche-Genentech training opportunities that arise throughout the year

  • Completes the Roche Standard Operating Procedure training modules

SELECTION CRITERIA:

 

 Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following 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.

QUALIFICATIONS & EXPERIENCE:

  • Experienced MD fellows, in the second half of their fellowship stage of medical subspecialty training, in major academic institutions

  • Exceptional senior residents might also be considered as fellowship candidates

  • Experience in generating publications and manuscripts‒ own publications track record is a plus

  • Teaching background is a plus

  • Fellows and their academic institutions must agree to uphold Roche-Genentech confidentiality and intellectual property contracts

  • Fellows must be able to work at Genentech headquarters in South San Francisco

  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance 

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values

  • Outstanding attention-to-detail

  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

  • Good interpersonal, verbal communication and influencing skills; can influence without authority

  • Strong written communication skills

  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

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

  • Ability to travel globally (<15%)

     

Please include your curriculum vitae and a cover letter that specifies:

  • your rationale for selecting this area of interest

  • initial ideas about your fellowship research initiative

2/26/21 Oncology Clinical Research Fellow Entry Level South San Francisco, California

Location: South San Francisco

Start Date: June 2021

Term: 1 year

Hours: 40 hours/week

Please only apply to this job posting if you are interested in the Oncology department.



GENERAL POSITION SUMMARY:

Genentech’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase Ib – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.  

Delivering superior clinical research requires close collaboration between academic and industry professionals.  The Genentech Clinical Research Fellowship program entails a collaboration between academic institutions and Roche-Genentech, offering experienced MD fellows interested in a career in clinical research, a one-year experience in this area. 

Roche, a world leader in clinical research, has generated large clinical databases from multiple randomized clinical trials and registries. Your own exceptional talents can help take us further, building on this data while giving you the opportunities you're seeking to propel your career.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES 

These would mainly consist of, but are not limited to:

 

1. Clinical Development Team  

  • Is involved in the design, set-up and execution of Phase I through Phase III clinical trials

  • Analyzes and interprets data from clinical studies, including biomarkers development, and analysis of patients’ samples

  • Is a member of the relevant Clinical Science Team (CST), participating in clinical strategy 

  • Participates as a core or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team 

  • Participates in strategic meetings (at study or project level) in order to gain a deeper understanding of the complexities and challenges of drug development

  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic area(s) of assignment, providing clinical expertise in the disease area for cross functional teams

  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and Therapeutic Area Experts (TAEs), as well as multidisciplinary internal groups, including other groups in PD or gRED, research, biomarkers development, regulatory, business development, commercial operations, legal, etc. providing clinical support across all relevant studies and programs 

  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

     

2. Clinical Fellowship Project 

  • Secures a mentor from their academic institution (if applicable)

  • Designs clinical research projects in his/her area of interest 

  • Partners with Biostatistics and Programming in order to generate the necessary analyses plans for the research projects

  • Is responsible for generation of abstracts or manuscripts for publication derived from the clinical research findings and presents the research findings at key conferences and other specialty meetings

  • Participates in relevant internal and external Roche meetings related to the projects

  • Completes the research projects within the one-year program

  • On an ongoing basis and at the conclusion of their one-year fellowship, presents his/her data to an internal peer review group

     

3. Education and Training

  • With support of the Genentech mentor, develops an educational project plan to improve his/her knowledge base on Drug Development

  • Participates in regular therapeutic area meetings on a variety of clinical topics

  • Participates in additional relevant Roche-Genentech training opportunities that arise throughout the year

  • Completes the Roche Standard Operating Procedure training modules

SELECTION CRITERIA:

 

 Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following 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.

QUALIFICATIONS & EXPERIENCE:

  • Experienced MD fellows, in the second half of their fellowship stage of medical subspecialty training, in major academic institutions

  • Exceptional senior residents might also be considered as fellowship candidates

  • Experience in generating publications and manuscripts‒ own publications track record is a plus

  • Teaching background is a plus

  • Fellows and their academic institutions must agree to uphold Roche-Genentech confidentiality and intellectual property contracts

  • Fellows must be able to work at Genentech headquarters in South San Francisco

  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance 

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values

  • Outstanding attention-to-detail

  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

  • Good interpersonal, verbal communication and influencing skills; can influence without authority

  • Strong written communication skills

  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

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

  • Ability to travel globally (<15%)

     

Please include your curriculum vitae and a cover letter that specifies:

  • your rationale for selecting this area of interest

  • initial ideas about your fellowship research initiative

2/26/21 Neurology Clinical Research Fellow Entry Level South San Francisco, California

Location: South San Francisco

Start Date: June 2021

Term: 1 year

Hours: 40 hours/week

Please only apply to this job posting if you are interested in the Neurology department.



GENERAL POSITION SUMMARY:

Genentech’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase Ib – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.  

Delivering superior clinical research requires close collaboration between academic and industry professionals.  The Genentech Clinical Research Fellowship program entails a collaboration between academic institutions and Roche-Genentech, offering experienced MD fellows interested in a career in clinical research, a one-year experience in this area. 

Roche, a world leader in clinical research, has generated large clinical databases from multiple randomized clinical trials and registries. Your own exceptional talents can help take us further, building on this data while giving you the opportunities you're seeking to propel your career.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES 

These would mainly consist of, but are not limited to:

 

1. Clinical Development Team  

  • Is involved in the design, set-up and execution of Phase I through Phase III clinical trials

  • Analyzes and interprets data from clinical studies, including biomarkers development, and analysis of patients’ samples

  • Is a member of the relevant Clinical Science Team (CST), participating in clinical strategy 

  • Participates as a core or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team 

  • Participates in strategic meetings (at study or project level) in order to gain a deeper understanding of the complexities and challenges of drug development

  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic area(s) of assignment, providing clinical expertise in the disease area for cross functional teams

  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and Therapeutic Area Experts (TAEs), as well as multidisciplinary internal groups, including other groups in PD or gRED, research, biomarkers development, regulatory, business development, commercial operations, legal, etc. providing clinical support across all relevant studies and programs 

  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

     

2. Clinical Fellowship Project 

  • Secures a mentor from their academic institution (if applicable)

  • Designs clinical research projects in his/her area of interest 

  • Partners with Biostatistics and Programming in order to generate the necessary analyses plans for the research projects

  • Is responsible for generation of abstracts or manuscripts for publication derived from the clinical research findings and presents the research findings at key conferences and other specialty meetings

  • Participates in relevant internal and external Roche meetings related to the projects

  • Completes the research projects within the one-year program

  • On an ongoing basis and at the conclusion of their one-year fellowship, presents his/her data to an internal peer review group

     

3. Education and Training

  • With support of the Genentech mentor, develops an educational project plan to improve his/her knowledge base on Drug Development

  • Participates in regular therapeutic area meetings on a variety of clinical topics

  • Participates in additional relevant Roche-Genentech training opportunities that arise throughout the year

  • Completes the Roche Standard Operating Procedure training modules

SELECTION CRITERIA:

 

 Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following 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.

QUALIFICATIONS & EXPERIENCE:

  • Experienced MD fellows, in the second half of their fellowship stage of medical subspecialty training, in major academic institutions

  • Exceptional senior residents might also be considered as fellowship candidates

  • Experience in generating publications and manuscripts‒ own publications track record is a plus

  • Teaching background is a plus

  • Fellows and their academic institutions must agree to uphold Roche-Genentech confidentiality and intellectual property contracts

  • Fellows must be able to work at Genentech headquarters in South San Francisco

  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance 

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values

  • Outstanding attention-to-detail

  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

  • Good interpersonal, verbal communication and influencing skills; can influence without authority

  • Strong written communication skills

  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

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

  • Ability to travel globally (<15%)

     

Please include your curriculum vitae and a cover letter that specifies:

  • your rationale for selecting this area of interest

  • initial ideas about your fellowship research initiative

2/26/21 Early Clinical Development, OMNI Clinical Research Fellow Entry Level South San Francisco, California

Location: South San Francisco

Start Date: June 2021

Term: 1 year

Hours: 40 hours/week

Please only apply to this job posting if you are interested in the Early Clinical Development (Ophthalmology, Metabolism, Neurology, Immunology, Respiratory) department.



GENERAL POSITION SUMMARY:

Genentech’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase Ib – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.  

Delivering superior clinical research requires close collaboration between academic and industry professionals.  The Genentech Clinical Research Fellowship program entails a collaboration between academic institutions and Roche-Genentech, offering experienced MD fellows interested in a career in clinical research, a one-year experience in this area. 

Roche, a world leader in clinical research, has generated large clinical databases from multiple randomized clinical trials and registries. Your own exceptional talents can help take us further, building on this data while giving you the opportunities you're seeking to propel your career.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES 

These would mainly consist of, but are not limited to:

 

1. Clinical Development Team  

  • Is involved in the design, set-up and execution of Phase I through Phase III clinical trials

  • Analyzes and interprets data from clinical studies, including biomarkers development, and analysis of patients’ samples

  • Is a member of the relevant Clinical Science Team (CST), participating in clinical strategy 

  • Participates as a core or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team 

  • Participates in strategic meetings (at study or project level) in order to gain a deeper understanding of the complexities and challenges of drug development

  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic area(s) of assignment, providing clinical expertise in the disease area for cross functional teams

  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and Therapeutic Area Experts (TAEs), as well as multidisciplinary internal groups, including other groups in PD or gRED, research, biomarkers development, regulatory, business development, commercial operations, legal, etc. providing clinical support across all relevant studies and programs 

  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

     

2. Clinical Fellowship Project 

  • Secures a mentor from their academic institution (if applicable)

  • Designs clinical research projects in his/her area of interest 

  • Partners with Biostatistics and Programming in order to generate the necessary analyses plans for the research projects

  • Is responsible for generation of abstracts or manuscripts for publication derived from the clinical research findings and presents the research findings at key conferences and other specialty meetings

  • Participates in relevant internal and external Roche meetings related to the projects

  • Completes the research projects within the one-year program

  • On an ongoing basis and at the conclusion of their one-year fellowship, presents his/her data to an internal peer review group

     

3. Education and Training

  • With support of the Genentech mentor, develops an educational project plan to improve his/her knowledge base on Drug Development

  • Participates in regular therapeutic area meetings on a variety of clinical topics

  • Participates in additional relevant Roche-Genentech training opportunities that arise throughout the year

  • Completes the Roche Standard Operating Procedure training modules

SELECTION CRITERIA:

 

 Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following 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.

QUALIFICATIONS & EXPERIENCE:

  • Experienced MD fellows, in the second half of their fellowship stage of medical subspecialty training, in major academic institutions

  • Exceptional senior residents might also be considered as fellowship candidates

  • Experience in generating publications and manuscripts‒ own publications track record is a plus

  • Teaching background is a plus

  • Fellows and their academic institutions must agree to uphold Roche-Genentech confidentiality and intellectual property contracts

  • Fellows must be able to work at Genentech headquarters in South San Francisco

  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance 

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values

  • Outstanding attention-to-detail

  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

  • Good interpersonal, verbal communication and influencing skills; can influence without authority

  • Strong written communication skills

  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

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

  • Ability to travel globally (<15%)

     

Please include your curriculum vitae and a cover letter that specifies:

  • your rationale for selecting this area of interest

  • initial ideas about your fellowship research initiative

2/26/21 Ophthalmology Clinical Research Fellow Entry Level South San Francisco, California

Location: South San Francisco

Start Date: June 2021

Term: 1 year

Hours: 40 hours/week

Please only apply to this job posting if you are interested in the Ophthalmology department.



GENERAL POSITION SUMMARY:

Genentech’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase Ib – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.  

Delivering superior clinical research requires close collaboration between academic and industry professionals.  The Genentech Clinical Research Fellowship program entails a collaboration between academic institutions and Roche-Genentech, offering experienced MD fellows interested in a career in clinical research, a one-year experience in this area. 

Roche, a world leader in clinical research, has generated large clinical databases from multiple randomized clinical trials and registries. Your own exceptional talents can help take us further, building on this data while giving you the opportunities you're seeking to propel your career.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES 

These would mainly consist of, but are not limited to:

 

1. Clinical Development Team  

  • Is involved in the design, set-up and execution of Phase I through Phase III clinical trials

  • Analyzes and interprets data from clinical studies, including biomarkers development, and analysis of patients’ samples

  • Is a member of the relevant Clinical Science Team (CST), participating in clinical strategy 

  • Participates as a core or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team 

  • Participates in strategic meetings (at study or project level) in order to gain a deeper understanding of the complexities and challenges of drug development

  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic area(s) of assignment, providing clinical expertise in the disease area for cross functional teams

  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and Therapeutic Area Experts (TAEs), as well as multidisciplinary internal groups, including other groups in PD or gRED, research, biomarkers development, regulatory, business development, commercial operations, legal, etc. providing clinical support across all relevant studies and programs 

  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

     

2. Clinical Fellowship Project 

  • Secures a mentor from their academic institution (if applicable)

  • Designs clinical research projects in his/her area of interest 

  • Partners with Biostatistics and Programming in order to generate the necessary analyses plans for the research projects

  • Is responsible for generation of abstracts or manuscripts for publication derived from the clinical research findings and presents the research findings at key conferences and other specialty meetings

  • Participates in relevant internal and external Roche meetings related to the projects

  • Completes the research projects within the one-year program

  • On an ongoing basis and at the conclusion of their one-year fellowship, presents his/her data to an internal peer review group

     

3. Education and Training

  • With support of the Genentech mentor, develops an educational project plan to improve his/her knowledge base on Drug Development

  • Participates in regular therapeutic area meetings on a variety of clinical topics

  • Participates in additional relevant Roche-Genentech training opportunities that arise throughout the year

  • Completes the Roche Standard Operating Procedure training modules

SELECTION CRITERIA:

 

 Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following 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.

QUALIFICATIONS & EXPERIENCE:

  • Experienced MD fellows, in the second half of their fellowship stage of medical subspecialty training, in major academic institutions

  • Exceptional senior residents might also be considered as fellowship candidates

  • Experience in generating publications and manuscripts‒ own publications track record is a plus

  • Teaching background is a plus

  • Fellows and their academic institutions must agree to uphold Roche-Genentech confidentiality and intellectual property contracts

  • Fellows must be able to work at Genentech headquarters in South San Francisco

  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance 

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values

  • Outstanding attention-to-detail

  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

  • Good interpersonal, verbal communication and influencing skills; can influence without authority

  • Strong written communication skills

  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

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

  • Ability to travel globally (<15%)

     

Please include your curriculum vitae and a cover letter that specifies:

  • your rationale for selecting this area of interest

  • initial ideas about your fellowship research initiative

2/26/21 Postdoctoral Fellow - Protein Analytical Chemistry Individual contributor South San Francisco, California

We are seeking a highly motivated, independent researcher for a postdoctoral position in the Protein Analytical Chemistry Department at Genentech. This research will encompass the structural analysis of biotherapeutic proteins utilizing an emerging higher order structure (HOS) technique: Hydroxyl Radical Footprinting-Mass Spectrometry (HFR-MS). The selected candidate will play a key role in pioneering the advancement of HRF-MS in an industry setting. Potential applications include optimization of formulation development, comparability assessments, structure/function linkage, and epitope mapping. In addition, the candidate will be able drive their own ideas and collaborate across Genentech and Roche Global. This work will include a strong cross-functional collaboration with the multiple other Pharmaceutical Technical Development (PTD) and Genentech Early Research and Development (gRED) departments.

The successful candidate will be a recent PhD graduate in Biochemistry, Chemical Biology, Structural Biology or a related discipline. A strong publication record should provide evidence of productive, independent contributions in science. The applicant must have demonstrated expertise in protein characterization using LC-MS analysis in areas such as native MS, ion mobility MS, post-translational modifications, cell-based biomarkers, and/or bottom-up MS technologies (HRF-MS and/or Hydrogen/Deuterium Exchange).  Prior experience with protein structure determinations and computational structural rendering is highly desirable. Applied applications of MS with cell-based systems is the most relevant skill set, but not a requirement. The successful candidate must be highly self-motivated, capable of working independently, have excellent oral and written communication skills, and enjoy working in a collaborative setting.

For information about the Postdoctoral Program at Genentech, please go to www.gene.com/careers/academic-programs/postdocs

2/26/21 Technology Enablement Director – Intelligent Safety Automation Individual contributor South San Francisco, California

Job Purpose

Roche’s Product Development Safety Risk Management (PDS) organization enhances healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimize their benefit-risk profile. 

The Pharmacovigilance Intelligent Automation and Business Systems Solutions (PVIS) group has overall responsibilities for business-owned safety systems activities, including business responsibilities of the evaluation, implementation and maintenance of technology solutions to enable business processes. It anticipates potential new enabling technologies, partners with industry and regulators, and identifies opportunities to test, deploy and incorporate new solutions into ways of working supporting the product lifecycle. PVIS Business System Owners areaccountable for maintaining the validated state of the PV systems complying with Computer System Validation (CSV) policy and processes. 

PVIS is continuing its transformation towards an open, dynamic, transparent, inclusive, collaborative and agile work environment. PVIS members are committed to deliver faster and bolder innovations, making key contributions to help implement and maintain PV systems in support of the Roche Pharma Vision, embracing the Pharma Operating Principles. They are motivated by purpose and spend their time contributing where it adds the most value. PVIS members work flexibly in a flat hierarchy as part of empowered, self-managed, multi-skilled teams, organized in a “flow-to-work” model. They work collaboratively and share expertise across the organization to remove silos and duplication, and deliver solutions through agile ways of working and an agile mindset.

You are a thought leader and senior business expert, responsible for leading initiatives, programs and/or workstreams relating to the design, development and implementation of computerized systems supporting critical PV and safety activities. As such, you are a key contributor to identify opportunities and co-create a pharmacovigilance systems strategy that pilots and implements efficient cutting-edge technology on new platforms, including intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies. With the primary aim of exploiting existing and emergent technologies that could be used to improve the effectiveness and efficiency of safety-focused activities and/or enable automation.  

You combine business systems analysis expertise, advanced knowledge of ‘Intelligent Automation’ (IA) technologies (e.g. machine learning, AI, robotic process automation, etc), and knowledge of relevant PV and safety business activities, with an ambition to enhance healthcare through information. 

You develop strategies and plans to promote and facilitate new and improved data flows and information sharing. Your expertise in analytics will be used to shape new technological and information-centric business solutions in the field of pharmaceutical safety. 

You possess subject matter expertise in relation to critical PV and safety activities, in order to anticipate IA-related opportunities for PV and safety innovation or continuous improvement, via systems and technologies. You apply the advanced expertise in intelligent automation with PV expertise to develop strategies or proposals to improve and innovate in assigned areas of systems activity, across business process clusters, in line with PDS and wider business goals.

You act as an expert adviser to assess and apply new machine learning methods to safety domain problems and to the integration of safety-related IA-based solutions with those deployed in the wider Roche organisation. You are capable of developing complex models, along with the technical training and testing approaches for such models, to evaluate suitability and ensure optimal performance.

You anticipate emerging Intelligent Automation technologies from research publications and industry partnerships/developments. You identify opportunities to design, test, deploy and incorporate new solutions into safety-related ways of working, supporting the Roche Safety strategy and wider business strategies (e.g. Pharma Vision). 

You collaborate closely with relevant counterparts across the Roche safety community (e.g. relevant GPOs, safety strategy teams, etc), with PD Informatics (PDIX) partners, and with wider Roche functions, as applicable, to co-create,design, pilot, test and/or implement the above.

You collaborate with the Group Director PVIS, wider Roche Safety Community stakeholders, and PDIX business partners to define and maintain a strategic PV systems roadmap that appropriately reflects the known and potential future opportunities to apply IA technologies across the safety arena: Considering wider industry trends, emerging technologies and other innovation opportunities.

You influence wider business and IT stakeholders, including at senior leadership levels, to drive cross-functional improvement and innovation of safety systems and technologies that support safety-focused business activities. You focus on sustaining an active and collaborative network externally, including collaborations with peer companies, industry organizations, system vendors and health authorities. You will typically represent Roche at relevant conferences and are likely to co-author relevant publications in your field.

You act as a coach and expert adviser to Business System Owners and members of the PV Business Systems Solutions Director/Analyst job family across all PVIS business areas, and provide guidance on intelligent automation technologies and their application.

Overall you play a key business-focused technology enablement leadership role and act as a key contributor for Roche strategic initiatives, programs and projects relating to safety activities and their automation. You will typically represent PDS in relevant Pharma and Roche-wide working groups relating to IA and you will be, or have the clear potential to become, a recognised safety industry leader in Intelligent Automation and Machine Learning. 

Your Primary Responsibilities are

  • Developing continuous improvement and innovation strategies or proposals for the safety systems landscape in the area of intelligent automation, in line with Roche Safety strategic focus areas, as well as PD, Pharma and corporate goals and ambitions

  • Ensuring that efficient cutting-edge technologies and platforms, like intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies are incorporated and maintained in collaboration with PDIX

  • Establishing and maintaining strong relationships with key stakeholders internally and externally, to share new ideas and to anticipate changing customer requirements

  • Maintaining advanced subject matter expertise by staying current with intelligent innovation technologies that are or can be applied across the Roche safety systems environment, to enhance PV business process execution and create efficiencies

  • In collaboration with key stakeholders, defining a Data Strategy and leading Safety Data Repurposing initiatives, with the objective of deriving value from investing in safety data assets and utilising them beyond their primary use, e.g. to help solve business and scientific questions on design of clinical trials, personalised safety and reverse translation

  • Keeping up to date on vendor solutions that include intelligent innovation approaches that are commercially available or in development 

  • Initiating and evaluating POCs and pilots based on the above for possible fit in the PV systems environment

  • Leading projects or workstreams to innovate and/or enhance PV systems in line with agreed systems roadmap and business goals

  • Mentoring PV Business Systems Solutions Directors/Analysts and Business System Owners to strengthen leadership capabilities, systems related competencies and skills, and team effectiveness

  • Working closely with the PVIS Group Director, relevant Global Process Owners, Business System Owners and PDIX Business Partners, apply intelligent automation expertise to define and co-create the safety compliance-critical aspects of overall system roadmap

  • Collaborating with wider PDS experts, other PD functions and PDIX to assess, align, co-create and implement such technologies in line with functional roadmaps. 

  • Additionally, you may represent PDS on relevant Roche or Pharma-wide forums that focus upon IA-related solutions

  • Embracing and promoting agile mindset and agile way of working, and adjusting quickly to an environment with changing priorities, technologies and regulatory framework

  • Promoting a culture of continuous innovation and a solution-orientated mind-set in order to enhance and evolve safety-related systems and automation solutions

  • Providing relevant SME input to the communication, training, implementation, follow-up and feedback, relating to IA-related safety solutions

The above statements are intended to describe the general nature and level of work being performed by you. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required.

Education, Skills and Experience

  • Degree in data sciences, computer sciences or similar field, graduate or higher-level degree preferred

  • Experience in the field of pharmacovigilance or product development preferred

  • Prior experience of the application of intelligent automation technologies in a relevant business setting is essential. Typically, with 10+ years of relevant experience of  managing and improving business systems in a problem-solving capacity, with typically 5+ years specifically involving the application of machine learning, AI and/or other emergent technologies.

  • Experience in network or line leadership roles: Leading global teams to deliver complex, cross-functional technology-enabled business projects of high business importance/risk in an international and multicultural organization

  • Extensive experience in the practical application of intelligent automation technologies, ideally in a safety-related environment and/or with broad awareness of relevant PV activities

  • In-depth understanding of key regulatory requirements, any associated external guidances, and their implications with respect to the design, validation, implementation, maintenance of or use of intelligent automation technologies in safety-related business settings. Typically, with emergent technologies, formal requirements and guidances may lag behind the practical application of technologies and therefore you will typically possess the ability to influence the creation of wider guidances and good practices, with internally or externally.

  • Highly developed communication, presentation and influencing skills, with the proven ability to establish effective collaborations across business units and to influence decisions without authority

  • Advanced strategic and analytical thinking skills, with the ability to rapidly assimilate complex information to inform decisions, and/or make effective business proposals in situations of ambiguity

  • Extensive expertise in the development of efficient software solutions to address complex business problems in a regulated and validated environment

  • Knowledge of database technologies, reporting and advanced analytics tools, industry standard safety systems and medical terminologies, e.g. MedDRA

Travel Requirements

International business travel up to 10% of the time may be required, depending upon the business location of the jobholder and ongoing business project activities.

2/26/21 Technology Enablement Director – PV Compliance Systems Individual contributor South San Francisco, California

Job Purpose

Roche’s Product Development Safety Risk Management (PDS) organization enhances healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimize their benefit-risk profile. 

The Pharmacovigilance Intelligent Automation and Business Systems Solutions (PVIS) group has overall responsibilities for business-owned safety systems activities, including business responsibilities of the evaluation, implementation and maintenance of technology solutions to enable business processes. It anticipates potential new enabling technologies, partners with industry and regulators, and identifies opportunities to test, deploy and incorporate new solutions into ways of working supporting the product lifecycle. PVIS Business System Owners areaccountable for maintaining the validated state of the PV systems complying with Computer System Validation (CSV) policy and processes. 

PVIS is continuing its transformation towards an open, dynamic, transparent, inclusive, collaborative and agile work environment. PVIS members are committed to deliver faster and bolder innovations, making key contributions to help implement and maintain PV systems in support of the Roche Pharma Vision, embracing the Pharma Operating Principles. They are motivated by purpose and spend their time contributing where it adds the most value. PVIS members work flexibly in a flat hierarchy as part of empowered, self-managed, multi-skilled teams, organized in a “flow-to-work” model. They work collaboratively and share expertise across the organization to remove silos and duplication, and deliver solutions through agile ways of working and an agile mindset.

You are a thought leader and senior business expert in areas relating to pharmacovigilance (PV) enabling technologies and their requirements. As such, you are a key contributor to identify opportunities and co-create a pharmacovigilance systems strategy that pilots and implements efficient cutting-edge technology on new platforms, including intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies.

You are responsible for leading major global initiatives, programs and/or workstreams relating to the development and implementation of computerized systems supporting the company’s PV system, its various component processes, and their business oversight.

You possess advanced subject matter expertise in relation to critical PV and safety activities, in order to anticipate technology-related opportunities for PV and safety process-focused innovation and continuous improvements. You apply such expertise to develop both overarching strategies and/or specific proposals to improve or innovate in assigned areas of systems activity, across business process clusters, and in line with PDS and wider business goals.

You will anticipate potential new enabling technology opportunities and partnerships from the external environment that may be relevant to enabling PV activities and you will identify opportunities to test, deploy and incorporate new solutions into ways of working that support PV and safety related GxP activities. You collaborate closely with relevant counterparts across the Roche safety community (e.g. PV GPOs, PDSO & Safety Affiliate teams utilizing PV systems, etc.), with PD Informatics (PDIX) partners, and with wider Roche functions, as applicable, to co-create, design, pilot, test and/or implement the above.

You have expert knowledge of, and maintains an overview of, current and upcoming global and local PV regulations pertaining to data and technological requirements, and you are readily able to anticipate future systems needs based on PV technology trends in the Pharma industry, and more specifically the regulatory landscape pertaining to PV and GCP safety.

You collaborate with the Group Director PVIS, wider Roche Safety Community stakeholders and PDIX business partners to specifically define and maintain a strategic PV systems roadmap: Considering wider industry trends, emerging technologies and other innovation opportunities.

You influence wider business and IT stakeholders, including senior leadership levels, to drive cross-functional improvement and innovation of PV systems and technologies that support PV and GCP safety processes.

You focus on sustaining an active and collaborative network, including external collaborations with peer companies, industry organizations, system vendors and health authorities.  You will typically represent Roche at relevant conferences and are likely to co-author relevant publications in your field. Furthermore, you may be required to represent Roche in relevant external initiatives that aim to establish standards or guidelines relating to the adoption of safety technologies (e.g. ICH, CIOMS, etc).

You will also act as a coach and expert adviser to Business System Owners and members of the PV Business Systems Solutions Director/Analyst job family across all PVIS business areas, and provide guidance on systems design and management.

You are also expected to act as a key advisor and contributor for strategic safety initiatives, programs and projects relating to PV and GCP compliance and quality, and represent PDS in relevant internal collaborations and committees.

Your Primary Responsibilities are:

  • Developing continuous improvement and innovation strategies, and related proposals, for the PV systems and GCP safety landscape, in line with Roche Safety focus areas and strategy, as well as wider PD, Pharma and corporate goals and ambitions

  • Ensuring that efficient cutting-edge technologies and platforms, like intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies are incorporated and maintained in collaboration with PDIX.

  • Establishing and maintaining strong relationships with key stakeholders internally and externally, to share new ideas and to anticipate changing customer requirements

  • Maintaining advanced subject matter expertise by staying current with global PV and GCP regulations, technology trends and commercially available system solutions that have to or can be applied to the Roche systems environment to remain in compliance with regulatory requirements and/or enhance PV processes and create efficiencies

  • Maintaining an overview and assessment of vendor solutions that are commercially available or in development 

  • Initiating and evaluating POCs and pilots based on the above for possible fit in the PV systems environment

  • Contributing to establish and maintain a safety data governance framework

  • Leading full-scale projects or workstreams to innovate and/or enhance PV systems in line with agreed systems roadmap and business goals

  • Providing guidance and managing deliverables of other colleagues for specific projects or initiatives

  • Mentoring PV Business Systems Solutions Directors/Analysts and Business System Owners to strengthen leadership, systems related competencies and skills, and team effectiveness 

  • Working closely with the PVIS Group Director, relevant Global Process Owners, Business System Owners and PDIX Business Partners, apply regulatory and technology expertise to define and co-create the safety compliance-critical aspects of overall system roadmap

  • Collaborating with PDS experts, other PD functions and PDIT to align and implement functional roadmaps and interfaces between PV compliance systems to reuse or share existing data and system functionality

  • Embracing and promotes agile mindset and agile way of working, and adjusting quickly to an environment with changing priorities, technologies and regulatory framework

  • Promoting a culture of continuous innovation and a solution-orientated mind-set in order to enhance and evolve PV systems

  • Providing relevant SME input to the communication, training, implementation, follow-up and feedback, relating to enabling PV system solutions

  • It is also possible in some circumstances that you may temporarily assume the Business System Owner role, where this required specific for new systems that are being development, until completion of the ‘go-live’ and hyper care phase, if needed

The above statements are intended to describe the general nature and level of work being performed by you. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required.

Education, Skills and Experience

  • Degree in life sciences, computer sciences or other relevant field, higher level degree preferred

  • Experience in pharmacovigilance is essential, with typically 10+ years of relevant systems related experience in pharmacovigilance, or closely related areas of clinical development

  • Experience in line or matrix leadership roles in a global organisation, with proven ability to deliver complex, cross-functional systems-related projects of high business importance/risk in an international and multicultural organization

  • Broad experience in a safety function and/or considerable exposure to PV activities, including collection, processing, reporting and analysis of pharmacovigilance data

  • In-depth understanding of key PV legislation, regulatory requirements and their implications with respect to the design, implementation and maintenance of PV systems

  • Highly developed communication, presentation and influencing skills, with the proven ability to establish effective collaborations across business units and to influence decisions without authority

  • Advanced strategic and analytical thinking skills, with the ability to rapidly assimilate complex information to inform decisions, and/or make effective business proposals in situations of ambiguity

  • Extensive expertise in the development of efficient software solutions to address complex business problems in a regulated and validated environment

  • Knowledge of database technologies, query and reporting tools, industry standard safety systems and medical terminologies, e.g. MedDRA

Travel Requirements

International business travel up to 10% of the time may be required, depending upon the business location of the jobholder and ongoing business project activities.

2/26/21 Senior VP Global Head of Clinical Development - Immunology, Ophthalmology, Infectious Disease Executive (SVP/GM) South San Francisco, California

Role Summary

The Global Head of Clinical Development for I2O (Immunology, Ophthalmology, Infectious Disease) will report directly to Roche’s Head of Global Product Development (PD) and Chief Medical Officer and will be a member of the Product Development Leadership Team (PDLT) and the Late Stage Portfolio Committee (LSPC). 

In this role, the Global Head will be responsible for creating and executing the global therapeutic area (TA) portfolio strategy for late stage I2O.  In partnership with the I2O Head of Global Product Strategy, this role leads investment decisions and prioritization across the portfolio.  The Global Head also provides technical guidance and high-level oversight to late-stage clinical trials, and Phase 1B combination studies and platforms across PD. 



Other key stakeholder relationships include collaborating with Early-Stage Research (from Genentech and Roche), the Personalized Healthcare team (PHC), Medical Affairs, Commercial, Regulatory, and Business Development senior leaders.

Functional Role:

  • Collaborates with Research and Early Development (pRED and gRED) to develop criteria for late stage investment in early molecule programs

  • Advances personalized healthcare (PHC) in collaboration with the PHC Center of Excellence

  • Ensures the timely progression of molecules through late stage clinical trials

  • Prepares communication, as an expert advisor, on late stage molecules to the relevant portfolio governance bodies, investigator meetings and global health authority meetings

  • Liaises with global health authorities to discuss the portfolio and strategically influences the acceleration of drug development and novel drug development pathways

  • Communicates to relevant governance bodies the impact of competitors' marketed or investigational drugs on late stage development projects

  • Represents Roche to media, policy forums, medical societies, and other external partners

  • Demonstrates effective people leadership as demonstrated by the Roche Leadership Commitments and Roche Pharma Operating Principles

  • Acts as a noted disease area expert with credibility to interface with key external regulatory and healthcare organizations and stakeholders (ie FDA, EMA, other regulatory bodies, payer organizations)

Product Development LT (PDLT) Role:

  • Collaborates with other PDLT members to design and deliver PDLT strategic initiatives and vision

  • Jointly accountable for regulatory approval and launch of molecules

  • Works as a member of PDLT and Clinical Science subgroup, actively participating in discussions and decision-making

  • Responsible for ensuring relevant clinical science input into PDLT decision-making and Product Development input into Clinical Science subgroup decision-making

  • Provides timely and quality information to the PDLT to ensure the team can make informed decisions

People Development and Management:

  • Responsible for leading and managing employees in the Product Development I2O organization: ~100 employees across the US, Switzerland, UK, and China

  • Selects and appoints Franchise Heads and leadership team (LT) members

  • Develops the clinical development talent pool for I2O and proactively manages succession planning

  • Sets a powerful personal example of behaviors expected from all individuals by living the Roche values of Integrity, Courage, and Passion

  • Fosters a culture of learning and creativity

  • Contributes to performance evaluation of clinical science team members and promotion, reward, and recognition

  • Allocates dedicated clinical science resources to projects per the TA budget approved by LSPC

  • Maintains overall Product Development focus on understanding and responding to customer needs and ensures a balanced input into PDLT decision making. 

  • Maintains the standards of information provided to the PDLT and I2O LT to ensure teams can make informed decisions

  • Ensures that governance functions have the appropriate input along the value chain

 

Attributes:

  • Visionary with bold and creative ideas for innovation, and ability to execute those ideas across a complex landscape

  • Open-minded, curious, adaptable, and courageous 

  • Pace-setter at forefront of a changing and competitive environment

  • Deep scientific rigor, medical and clinical research background and knowledge

  • Late Stage Development experience

  • Internal and external recognition and respect

  • Inspires and influences people at all levels - Senior Leaders and employees 

  • Leadership and management excellence, servant leader skills in coaching people and helping them grow and develop

  • Exceptional collaborator with strong influencing skills

  • Excelled at a premier pharmaceutical or biotechnology company or academic institution

Requirements:

  • M.D. with board certification in any disease area relevant to I2O and knowledge of science of the disease area at a molecular level

  • A proven leader ideally with 15+ years clinical/drug development experience in the biotechnology/pharmaceutical industry/academia with a minimum of 10 years direct management experience

  • Extensive experience leading the design, conduct, analysis, and reporting of clinical studies, successful US Investigational New Drug (IND), Biologics License Applications (BLA)/New Drug application (NDA), and Committee for Medicinal Products for Human Use (CHMP) filing experience preferred

  • Thorough understanding of Global regulatory requirements

  • Significant positive interactions with key opinion leaders/investigators.

  • Proven ability to successfully leverage external partnerships

  • Proven ability to inspire and motivate a diverse group of M.Ds, clinical scientists, and employees at all levels

  • Accomplished record of leading cross-functional teams in a highly matrixed organization.

  • Proven ability to effectively work in a global organization with diverse cultures, showing aptitude in modifying leadership style

2/26/21 Bioinformatics Software Engineer, Cellular and Tissue Genomics Individual contributor South San Francisco, California

As a bioinformatics software engineer within the Data Science and Statistical Computing group in the Bioinformatics and Computational Biology department of Genentech Research, you will work with computational biologists and software engineers to develop and improve the next generation of genomic data infrastructure. You will lead the development of scientific databases and scalable data processing systems and APIs to enable interactive programmatic and visual data analysis. You will provide pragmatic engineering leadership in collaboration with scientists and other engineers to facilitate deep exploration of multidimensional preclinical and clinical omics data. Your infrastructure and tools will enable our scientists, across a range of computational expertise, to discover drug targets and biomarkers from high-throughput data and ultimately deliver life saving therapies to our patients.

You should be passionate about sustainable software engineering practices, the transformative potential of health-related data, and our mission to improve the lives of patients. You should have a flexible and learning mindset, be able to work in a fluid and dynamic environment, be comfortable leading globally distributed development teams and have a strong desire to pursue creative solutions to challenging problems.

Responsibilities

  • Work with business analysts and computational scientists to understand and conceptualize the complex, emerging needs of our scientists, whether they are working at the keyboard or the bench.

  • Collaboratively and pragmatically solve scientific software engineering challenges encountered at the forefront of genomics, particularly those related to the scalable storage, collaborative analysis and interactive visualization of large, multi-omics datasets. Plan and prioritize complex scientific software projects in conjunction with collaborators, steering committees and other stakeholders.

  • Lead local and off-shore engineering teams to support your software development efforts.

  • Effectively communicate strategies, ideas, goals and progress to departmental, cross-functional and senior management.

  • Contribute to the broader scientific community through open-source software development.

Requirements

  • BS or higher in bioinformatics, computer science or related fields.

  • 5+ years experience (including any graduate school) developing tools for data analysis.

  • Seniority of position will depend on experience and other factors. Experience supporting data science activities using FAIR data management and reproducible practices.

  • Adept at object-oriented programming, with proficiency in Python, C++ or Java.

  • Familiar with a popular high-level language used in data science, such as Python or R.

  • Expertise in operating on large data, such as data stored in relational and non-relational databases, array stores, HDF5 files or parquet files.

  • Demonstrated adherence to best practices in software engineering, particularly usability, version control, testing, and appropriate use of abstraction.

  • Demonstrated ability to lead heterogeneous engineering teams and interface with domain experts and users.

  • Demonstrated ability to effectively communicate about complex bioinformatics problems to peers, users and leadership.

  • Biological domain knowledge and basic data analysis skills are desirable but not required.

  • Familiarity with formal build/release/deploy and continuous integration frameworks (e.g., Jenkins) is a plus.

In addition,

  • You are enthusiastic about working in a scientific environment, especially one that is related to drug discovery and development.

  • You are a quick learner, are curious about new areas and the opportunity to build expertise, and courageously and creatively take initiative to see your ideas implemented.

  • You are attracted by the challenges of developing software that solves universal problems in bioinformatics.

  • You are able to perform at a high level in a fast changing and demanding environment.

  • You are pragmatic about the tradeoffs between features, quality, and timeliness.

2/26/21 Lead Solution Support Engineer - Remote Team Leader Indiana

  • Excellent analytical, problem analysis and decision-making skills
  • Effective planning, organizational and territory and time management skills
  • Prior experience in coaching/mentoring junior level staff preferred
  • Prior leadership or lead worker experience and proven success in overseeing and guiding a work team’s functional activities
  • Successfully completes training and certification as defined by RD Services Leadership and policy
  • Advanced knowledge of information technology with the ability to communicate knowledge to lower level staff
  • Advanced knowledge of basic lab instrumentation and testing
  • Highly effective written/verbal communication, organization and prioritization skills
  • Highly effective customer service skills, including leadership, negotiation, persuasion and conflict resolution skills
Minimum Requirements (required): The minimum education, knowledge, experience, skills and attributes required to perform the essential functions of this job.
  • Bachelor’s Degree in Computer Science preferred, Information Technology, Management Information Systems, and six years of laboratory IT, general IT, product line experience or 8 years of experience.
  • Technical skills within product groups; including Microsoft Windows, Microsoft SQL, Microsoft IIS, Oracle, Apache, JBoss, Drupal, PHP, MySQL, Networking, Security and Intersystems Cache
  • Familiar with healthcare domain integration standards (ASTM, HL7, IHE, DICOM, HIPAA, ADT, etc.)
  • Experience with file parsing (XML, XSLT, etc.)
  • Knowledge of the clinical customer base and critical components of an LIS and laboratory IT processes and workflows
  • Effective planning, organizational and territory and time management skills
  • Prior experience in coaching/mentoring junior level staff preferred
  • Prior leadership or lead worker experience and proven success in overseeing and guiding a work team’s functional activities
  • Excellent analytical, problem analysis and decision-making skills
  • Ability to troubleshoot problems, consult and drive resolution
  • Effective communication skills; ability to effectively communicate with and translate requirements for both technical and non-technical groups

Colorado applicants are not eligible#LI-PK1
2/25/21 Intern - Corporate Groups - Strategy & Business Operations Entry Level South San Francisco, California

Start Date: May 18, 2021 (Summer 2021)

Work Hours: 40 hours per week 

Length of Assignment: 3 months

Education Level: Bachelor's (must be enrolled in or completed their 2nd year) and above

Preferred Majors/Disciplines: Chemical Engineering & Biochemical Engineering, Mechanical Engineering.

Given the current uncertainty of the global pandemic and work from home situation for 2021, this internship is currently planned to be virtual with the option for interns to work remotely from within the U.S. Borders. We will keep candidates informed if this changes. 

The Strategy & Business Operations (SBO) team strives to make great work possible by delivering value-add services across the Site Services network that result in cross-functional alignment, cost optimization and enhanced employee experiences.

We collaborate with our Site Services colleagues and partners to provide expertise, leadership, and strategic guidance in business process optimization, strategic consulting, technology & analytics, communications, governance, and learning & development.

Job Description/Responsibilities

The intern would be responsible for supporting the Program Manager responsible for implementing the following two key processes. The activities would include:

  • Portfolio Prioritization process- interacting with the SPOCs within all Site Services functions, data collection, data analysis and updating portfolio dashboard

  • Risk Management process - coordinating Risk Assessment meetings, supporting facilitating risk assessments, capturing risk scores and trends on Risk Matrix, updating risk dashboard and maintaining Site Services Risk Log.

  • If there is interest, the intern may assist the Site Services communications team with communication plan development and execution.

Requirements/Qualifications

  • Self-driven, Quick learner, Organized

  • Good written & verbal communication skills

  • Well versed with MS Office Suite, gSuite

  • Experience with risk assessment proces preferred

2/25/21 Intern - Corporate Groups - Design & Construction Entry Level South San Francisco, California

Start Date: May 18, 2021 (Summer 2021)

Work Hours: 40 hours per week 

Length of Assignment: 3 months

Education Level: Bachelor's (must be enrolled in or completed their 2nd year)

Preferred Majors/Disciplines: Construction Management, Environment Health & Safety, Engineering, Life Sciences or Architecture.

Given the current uncertainty of the global pandemic and work from home situation for 2021, this internship is currently planned to be virtual with the option for interns to work remotely from within the U.S. Borders. We will keep candidates informed if this changes. 

Design, Engineering, and Construction Services (DECS) is a group within Design & Construction (D&C).  The DECS Group is comprised of SMEs (Subject Matter Experts) in the following disciplines: Architecture, Mechanical, Electrical, Automation, Environmental Health & Safety, and Construction Services, which includes Badging & Training, Project Coordination and Closeout.  Responsibilities by the DECS Group includes providing subject matter expertise in respective disciplines to D&C Project Managers who execute ~180 construction projects annually for customers within SSF campus.  

Job Description/Responsibilities

Update Streamline / Refresh Safe Work Plan that is required prior to a project receiving approval to begin. The Safe Work Plan describes in detail how the hazard identified will be managed to protect our people, our campus and environment safe. 

  • Work with key stakeholders to address concerns and enhance the process. 

  • Update process to increase efficiency and effectiveness. 

  • Develop swimlanes to depict the process. 

Develop Incident Management Training & Expectations. 

  • Work with key stakeholders to develop protocols for incident management. 

  • Identify and implement areas of improvement to enhance the process. 

  • Co-create Root Cause Analysis training for facilitators and participants. 

  • Create instruction/ expectations for developing an incident report. 

Requirements/Qualifications

  • Works with manager to establish priorities and timelines. Work is reviewed in progress for soundness of judgment and overall adequacy and accuracy.

  • Comfortable working with databases and enterprise business systems. Well-versed in Excel and/or gSheets (Pivot tables, formulas, etc). Knowledge of Quickbase a plus.

  • Proficient in standard office suites such as Microsoft Office (Word, etc.) and Google Applications (Mail, Calendar, Documents, etc.).

  • Achieves results under very general supervision and guidance, receiving more detailed instructions on new assignments.

  • Effectively communicates topics, requirements, and projects to individuals in and out of department.

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Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.