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Date Job Title Job Level Location
8/3/20 Head of CPS Executive (Director/VP) Seoul

The responsibilities in this role include (but are not limited to):

  • Leads and oversees a Sales and Marketing function and team for the assigned Business Unit.
  • Leads a multidisciplinary team with responsibility for sales and marketing strategic, financial and operational results and overall success.
  • Identifies, drives and executes marketing, sales and related commercial strategies, plans and tactics
  • Accountable for the profit and loss (P&L) of all products overseen.
  • Cascades global vision, strategies to local team and implements them
  •  Recommends capital investment, investment, business expansion, coordinates of management of projects and activities once they are approved
  • Selects, develops and evaluates employees ensuring the efficient operation of the function. 
  • Ensure to sound business practices and compliance with business ethics 
  • Ensure robust processes are in place to support our compliance efforts 

To be successful in this role, your profile ideally includes

  • Bachelor’s degree or equivalent to that
  • 10 + years' experience in the area of medical devices (e.g. IVDs)
  • Ideally experience in Life Cycle Management and in multifunctional / global teams (direct /indirect)
  • Expert communicator, and ability to influence various, complex internal/external stakeholders in a matrix environment
  • English proficiency and regional language proficiency
  • Ability to work in a fast paced environment and manage high workloads through effective techniques such as prioritization and delegation
8/3/20 Team Lead - Media/Social Service Delivery (Digital Customer Experience) Manager with direct reports South San Francisco, California

The Team Lead will report to the Director of Program and Delivery Management Team and will be accountable leading the delivery team for a specific channel and digital service (Media, Web, or Relationship Management) and overseeing operations within Digital Customer Experience (DCX).  DCX is a functional group within Genentech Business Operations (GBO) comprised of experienced digital experts who partner across Commercial, Medical and Government Affairs (CMG) to orchestrate and deliver integrated digital customer experiences that drive measurable business outcomes.

Key Responsibilities

  • Responsible for the day-to-day alignment, enablement, coaching, and oversight of DCX Delivery Lead and Delivery Managers
  • Oversee service delivery roadmap to define future Web/Mobile, RM/Email or Media/Social digital operations
  • Actively manage team resourcing and capacity, understanding team workload and prioritization of business needs
  • Optimize our DCX operations for maximum efficiency with existing resources
  • Find, attract, develop, and retain highly talented people
  • Establish clear expectations and hold team accountable for performance, achieving objectives and driving impact
  • Actively participate in DCX LT driving department culture, talent management, and team engagement
  • Collaborate with DCX LT to contribute to the strategic direction and define long-term and short-term priorities
  • Optimally align and flexibly allocate resources to support delivery against business goals and priorities while balancing portfolio-level needs
  • Leads and/or participates in fit for purpose and flexibly deployed work product teams across the CMG network based on areas of expertise

Skills and Competencies

  • Domain expertise in digital marketing and deep familiarity with web/mobile, media/social or RM/Email production marketing technology, processes, and tools
  • Strong process development expertise for scaling service delivery
  • Ability to influence, inspire, and mobilize individuals and teams across CMG
  • Strong planning, critical thinking and problem solving skills
  • Ability to anticipate business needs and drive clarity in ambiguous situations
  • Bias for action, strong sense of immediacy, and drive to achieve objectives
  • Data-driven decision making
  • Ability to think and act with an enterprise mindset and portfolio perspective
  • Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities

Qualifications and Experience

  • Bachelors degree required with MBA or other related graduate level degree preferred
  • 8-10 years experience with the majority working in a digital marketing function
  • Previous people manager experience required
  • Demonstrated experience developing others and ensuring team success by inspiring and enabling team best practices, guidelines, and process improvements

https://www.gene.com/careers/commercial-operating-principles

#LI-KG1

8/3/20 Associate Scientist (Bioinformatics) Individual contributor South San Francisco, California

Genentech is seeking a highly motivated computational scientist to leverage machine learning and single cell technologies to study disease biology in neuroscience, immunology, and oncology. 

The successful applicant will develop new analytical approaches for integrating public and private single cell data assets as well as incorporating genetic and other high dimensional data in these analyses. Additionally, they will collaborate with an interdisciplinary team of therapeutic area scientists, computational biologists, human geneticists, and statisticians to support our therapeutic programs. The successful candidate will drive an independent research program with publication of scientific or methodological papers and internal collaborations to use newly developed tools, work closely with our Data Sciences and Statistical Computing team to develop software tools for the management and modeling of single cell data, and work closely with our Translational Genomics group to apply and validate new tools in prioritized therapeutic areas.

Qualifications:

  • Postdoctoral training or exceptional PhD experience in bioinformatics, biostatistics, computational biology, or a similar field.
  • Strong scientific publication record.
  • Excellent communication and data presentation skills, including the ability to present complex scientific results to a diverse audience.
  • Ability to work successfully as the bioinformatics lead in an interdisciplinary team.
  • Intense curiosity about the biology of disease and eager to contribute to scientific efforts focused on understanding the molecular mechanisms underlying disease etiology.
  • Relevant biological knowledge in immunology, airway biology, wound repair, and/or fibrotic processes.
  • Deep understanding of computational techniques for analyzing high-throughput genomic and transcriptomic datasets and an interest in applying novel approaches to explore and integrate such data (whole exome sequencing, single-cell RNA-seq, ATAC-seq, etc).
  • Demonstrated competence in a programming language such as python or R, experience with version control systems, and familiarity with high-performance computing environments.

8/3/20 Scientific Researcher/Senior Scientific Researcher - Small Molecule Process Chemistry Individual contributor South San Francisco, California

Genentech, a leader in bio-pharmaceutical sciences, is seeking a highly motivated and talented researcher with a proven track record of laboratory achievements to join our growing Department of Small Molecule Process Chemistry. Responsibilities of the position include:

  • Discover and develop process chemistry by conducting experiments to scout synthetic routes and to optimize reactions for yield, selectivity, and product purity.
  • Demonstrate synthetic processes at the laboratory and kilogram scale for timely delivery of early and mid-phase small molecule development candidates in accordance with cGMP, ICH and FDA/EMA regulations.
  • Develop crystallization processes to isolate synthetic intermediates and to control the bulk quality attributes of the API conducive to successful development and formulation requirements.
  • Make detail-oriented observations; interpret and document results via batch records and milestone development reports.
  • Interact with cross functional team members and contract manufacturing partners.
  • Keep current with developments in the field through peer-reviewed journals and other media, and maintain a scientific profile both internally and externally.

The ideal candidate will meet the following requirements. The level of the position will depend on the qualifications of the selected candidate:

  • BS with 3+ years of relevant experience or MS in chemistry. Candidate with MS in organic chemistry is highly preferred. Applicants are encouraged to provide a research summary along with their CV.
  • Must have record of innovation and success in multiple projects over the course of their industrial career to be considered for the more senior level.
  • A publication record is desirable, but candidates without peer-reviewed publications may be considered for the Scientific Researcher level. Candidates with a proven record of scientific publication may be considered for the Senior Scientific Researcher level.
  • Strong working knowledge of the latest developments in contemporary process chemistry including but not limited to chemo- and/or bio-catalysis, asymmetric transformations, and organometallic chemistry; experience in heterocyclic chemistry is also desired.
  • Demonstrated experience at the kilogram delivery scale and early- to mid-phase route optimization is strongly preferred, but candidates of exceptional promise without this experience will also be considered.
  • The ability to take initiative, solve problems independently, work in teams and

      communicate clearly (in both oral and written form) are essential skills for this position.

#LI-BK2

8/3/20 Head of Digital Pathology, Oncology Biomarker Development Manager with direct reports South San Francisco, California

Primary Role:

The Associate Director for Digital Pathology in Oncology Biomarker Development (OBD) provides scientific and strategic leadership and operational oversight of digital pathology efforts in support of therapeutic and disease-based biomarker and companion diagnostic activities across the portfolio. This role requires an individual with outstanding communication and leadership skills, as well as a cross-enterprise mindset to closely collaborate across the Roche organization (Pharma early and late stage drug development, Diagnostics, Flatiron Health, and Foundation Medicine), and key external partners. Working with world-class life scientists, image analysis experts, and diagnostics leaders, you will champion the vision, and drive the strategy and roadmap for application of digital and computational pathology in our clinical and translational programs to elucidate mechanistic insights, and develop image-based biomarkers and clinical tests that will personalize patient care.

Responsibilities:

  • Accountability for strategic leadership and oversight of the digital pathology program across translational research and clinical development
  • Lead in bringing together the cross-functional activities needed to deliver clinical grade digital pathology platforms and tests
  • Provide strategic insight, outstanding leadership, and effective management to direct reports and their associated teams
  • Collaborate extensively and effectively with key internal and external stakeholders to develop strong partnerships and collaborations
  • Represent OBD’s digital pathology accomplishments externally through presentations at key national and international meetings, and interactions with our key investigators
  • Work with pathologists, cancer biologists, bioinformaticians, and statisticians to build and deploy algorithms that advance digital pathology-based biomarker development

Requirements:

  • PhD, MD or PhD/MD degree in a relevant scientific field (e.g., pathology, cancer biology, molecular oncology, computer science), with at least 10 years of industrial or relevant academic leadership experience; will consider masters degrees with 15+ years experience
  • Extensive domain knowledge and expertise in digital pathology or image analysis, preferably with experience in building image-based clinical tests
  • Experience in drug or diagnostic development, including advanced understanding of critical development functions
  • Demonstrated experience with the development of machine learning, AI, and deep learning algorithms would be desirable
  • Excellent record of scientific accomplishment
  • Experience in leading and developing diverse people, groups, and teams
  • Significant experience and ability to drive to effective decisions and execute on programs
  • Sustained management and leadership experience
  • Outstanding communication skills
  • Ability to work well in a fast-paced, multicultural, and global environment

#LI-KM2

8/3/20 Senior Scientific Researcher, Human Genetics Individual contributor South San Francisco, California

The Cancer Immunology Department is seeking a highly motivated Senior Scientific Researcher to perform discovery research at the interface of human genetics, immunology and cancer. The successful candidate will lead research projects to implement and apply statistical genetics methods and integrate additional data modalities such as RNA-seq or tumor genomes to identify and enhance our understanding of novel therapeutic targets and biomarkers, and will be expected to make intellectual as well as technical contributions to the team.

Responsibilities: 

  • Perform disease-oriented research with a focus on reverse translation, utilizing both clinical trial data and external resources (academic collaborations, population biobanks)
  • Independently design, execute, analyze and present studies to various forums within the department and across the wider Research organization.
  • Collaborate closely with internal as well as academic collaborators

Genentech provides an exceptional research environment composed of internationally recognized leaders as well as state of the art core facilities with cutting edge technologies and computational resources to support all research activities. You will have the opportunity to participate in the discovery and investigation of drug targets, and contribute to a better understanding of individual differences in patients’ responses to cancer immunotherapy. We provide a highly collaborative community, and you will work closely with other researchers in the areas of Cancer Immunology, Human Genetics, Bioinformatics and Statistics.

Qualifications:

The successful applicant will have a PhD in human or statistical genetics or a related field and experience in an academic or industry setting. Candidates must have a documented record of professional achievement in the form of impactful publications, and must be familiar with statistical association (e.g. Plink, SAIGE) and fine-mapping approaches (“variant-to-function”). Expertise in the use of a high-level programming language such as R (preferred) or Python for statistics and computational biology is required, as well as familiarity with UNIX and high-performance computing environments. Experience in differential expression analyses is a plus. Excellent oral/written communication skills, creative problem-solving flexibility, and the ability to integrate detailed analyses into a larger disease-oriented context will be expected.

#LI-GL1

8/3/20 Senior Scientific Researcher, Immunology Individual contributor South San Francisco, California

The Wilson Lab the Department of Immunology at Genentech is seeking a highly talented, driven and motivated Senior Scientific Researcher to investigate novel pathways, biologies and potential therapeutic targets in the field of Immunology. Facilitated by fruitful collaborations with other labs in human genetics, biomarker discovery and early clinical development, the candidate will both drive the research and early development of novel targets and explore new pathways for new target discovery. Using state of the art techniques and technologies, the candidate will develop in-vitro and in-vivo systems to test the involvement of these new pathways and molecules in the pathogenesis of inflammatory diseases. Understanding the mechanism of action (MOA) of new targets, focusing on both innate and adaptive immune responses, will be a core focus of the work. The candidate will be responsible for advancing research stage programs into early clinical development, providing both scientific and technical expertise and generating solid proof of concept data.

https://www.gene.com/scientists/our-scientists/mark-s-wilson

Who You Are

  • Applicants must have a PhD degree and post-doctoral experience in immunology, molecular biology, biochemistry or related field and will have a good understanding of cytokine biology and cytokine receptor signaling.
  • Have a documented record of professional achievement in the form of high-quality publications.
  • Be theoretically and practically well versed in immunology and molecular immunology techniques such as primary cell isolation from tissues, in vitro stimulation of hematopoietic / immune cells, advanced flow cytometry (8+ colors), cellular immunological assays, molecular biology, ELISA/MSD, qRT-PCR/RNAseq/scRNA-Seq, WB and have experience or be willing to develop in-vivo models to test pathways.
  • Have excellent communication skills and be committed to teamwork-oriented discovery.
  • Can present research at intra- and inter-departmental meetings and work effectively as part of a team.
  • Qualified candidates should be adept at independently designing, executing and interpreting experiments.

#LI-BK2

8/3/20 Postdoctoral Fellow- T Cell Therapy- Analytical Development Individual contributor South San Francisco, California

Key Responsibilities/Tasks

Seeking a creative researcher for a postdoctoral position in the T cell engineering group within Pharma Technical Development at Genentech to investigate and establish innovative analytical technologies to characterize cell therapy products.

The successful candidate is expected to work independently in a team setting and will collaborate with internal (Research and other Pharma Tech Development groups) and external partners to support the development of novel analytical methods with a complex mechanism of action.

Qualifications:

  • A Ph.D. with 0-2 years of postdoc experience in Biological Sciences such as biochemistry, immunology, molecular and cell biology, and other related fields.
  • Autologous or allogeneic Cell Therapy engineering or analysis experience are preferred.
  • Experience in multicolor flow cytometry is preferred
  • Expertise in single-cell analysis platform technologies with related publications is preferred.
  • Strong collaborative, communication, and organizational skills.
8/3/20 Senior or Principal Medical Director - Cellular Immunotherapy, Oncology Early Clinical Development Individual contributor South San Francisco, California

The Early Clinical Development (ECD) Oncology group at Genentech is seeking a talented Physician Scientist to lead its neoantigen directed cellular immunotherapy program. The

Senior or Principal Medical Director will formulate the development strategy for one or more engineered T cell products that harbor T-cell receptors selected to recognize an individual patient’s tumor. The Senior or Principal Medical Director will play a major role in building a T cell therapy franchise that will be a pillar of Genentech’s overall cancer immunotherapy strategy. ECD Oncology oversees a broad oncology portfolio and drives development from first-in-human studies through proof-of-concept and decision-making regarding initial pivotal studies.

The Senior or Principal Medical Director will lead a cross-functional Development team responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within the T-cell therapy program while driving long-range strategic plans and managing collaboration with corporate development partners. Additional responsibilities will involve contributing development expertise to internal governance bodies, therapeutic area scientific strategies, programs in Research, and assessment of in-licensing opportunities. The Senior or Principal Medical Director is expected to act as a leader within ECD and may manage one or more direct reports.



Requirements for the position include the following

  • M.D. with board certification, or eligibility, in Oncology, Hematology, or related specialty
  • M.D. required and Ph.D. a plus
  • Substantial experience in the clinical development of cell-based immunotherapies highly preferred
  • Excellent scientific record with experience in laboratory-based cancer research and/or oncology clinical trials within an academic institution or the biopharmaceutical industry
  • Experience in the pharmaceutical or biotechnology industry preferred
  • Desire and ability to effectively participate within multi-disciplinary teams
  • Ability to interact with external experts and investigators effectively

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology

industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for

cancer and other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset and we are dedicated to remaining a great place to work.



Genentech is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

#NMA #cellular immunotherapy #biotechnology #pharmaceuticals #biopharma #genentech #roche #sanfrancisco #bayarea

8/3/20 Sr. QC Analyst Individual contributor Vacaville, California

The Senior QC Analyst in QC Microbiology is responsible for sampling, testing, and release of utility systems and process spaces (cleanrooms) in Vacaville.

This position has a designated Day shift for Wednesday to Saturdays.

Responsibilities

  • Perform routine and non-routine sample collection according to cGMPs
  • Perform a broad variety of basic and moderately complex tasks in support of lab operations
  • Perform assay/laboratory maintenance functions
  • Prepare basic and complex laboratory reagents
  • Order and maintain lab supply inventory
  • Perform equipment qualification and maintenance
  • Perform data verification and review
  • Identify assay anomalies
  • Initiate/assess discrepancies
  • Anticipate problems and notify supervisor
  • Understand theory of assays; use SOPs, validation protocols, specifications, trends, and expertise to propose solutions to assay issues
  • Identify problems and propose solutions to systems, procedures, and training materials
  • Understanding/knowledge of QC Microbiology systems
  • Coaching of others in assay/laboratory functioning using higher level of technical expertise
  • Assume responsibility for training and communication of issues
  • Good understanding of global systems and GMP Compliance requirements/regulations
  • Assist in preparing for internal and external inspections by ensuring Laboratory is inspection ready at all times
  • Coordinate with customers to support operational activities
  • Any other duties as assigned by management

Qualifications

  • B.S./B.A degree in a scientific discipline, or an AA degree with 5+ years of related experience, or High School Diploma and 7+ years of related experience, or an equivalent combination of education and experience.  Degrees are preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry
  • Environmental monitoring, water collection, compressed gas testing for viable, non-viable, moisture and oil attributes, as well as Bioburden, Endotoxin, Conductivity, TOC, and/or Non Condensable Gas Testing of water/steam systems experience is a plus 
  • Experience with facilities and utilities systems
  • Experience with classified cleanroom gowning
  • Strong verbal and written communication skills, ability to organize and present information both formally and informally
  • Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures
  • Routinely exercises sound judgment, reasoning, and problem solving
  • Capable of working under moderate supervision, independently and as a team, and determining own short-term priorities
  • Capable of completing assigned responsibilities efficiently and keeping supervisor informed
  • Ability to create an environment of strong team spirit with timely and effective communications
  • Develop ability to influence using technical and personal reasoning

Work Environment/Physical Demands/Safety Considerations

  • Capable of lifting up to 30 pounds on flat ground and up stairs
  • Able to work in process space areas requiring cleanroom gowning, including mask 
  • Able to work in a laboratory environment in the presence of hazardous materials
  • Laboratory work requires use of PPE, glassware, needles, syringes, hot water baths, and hot plates
  • Able to make repetitive motions and manual manipulations
  • Able to use stairs, bend, stoop, kneel as required for sampling and gowning procedures
  • Must pass required vision screening
  • Must be able to work Day Shift or Swing Shift and weekends

Please note that this position is not eligible for relocation. Only local candidates will be consnidered.

#LI-TS2

8/3/20 Head of PV Operations (US Drug Safety) Manager with direct reports South San Francisco, California

Job Title: Head of PV Operations

Department: US Medical Affairs

Level: D1

Location: South San Francisco

Reporting: Head of USDS

Summary of Position:

Responsible for the leadership and management of all US Drug Safety (USDS) activities related to PV Operations, which includes activities related to Study Management, MAP processes, and Vendor Oversight.

Job Duties/Responsibilities:

  • Demonstrates high level proficiency and expertise of drug safety concepts to include monitoring, tracking, and completion in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs). Able to effectively demonstrate strong leadership across all PV Operations Manager related activities and extensive breath of knowledge of key stakeholders external to USDS.
    • Accountable and responsible for reconciliation activities related to ICSR processing
    • Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics
    • Responsible for implementing PV related activities within the scope of PV operations as outlined in relevant agreements with license partners and/or other parties [as required]
    • Maintains strong relationships with Global Safety and other Affiliates to share best practices
    • Responsible for the oversight of ICSR activities as they pertain to PV operations
    • Represent US affiliate on global workstreams or committees, as required
    • Accountable for the management of GvP vendor Service Provider Oversight Plans (SPOPs)
  • Demonstrates expertise in study management and Market Research and Patient Program [MAP] activities
  • Accountable for maintaining oversight over Source data quality check [SDQC] activities and ensure tracking and timely completion
  • Will collaborate with USDS Leadership Team to drive the organizational strategy, goals, and objectives for the department, and will determine the processes needed to support both local and global safety strategies
  • Accountable for coaching and developing direct reports by providing an environment that encourages ongoing personal and professional development
  • Responsible for the performance of assigned personnel against departmental processes, standards and performance goals, and for ensuring successful completion of all training required for the role
  • Responsible for the identification of talent to be developed into potential succession candidates.
  • Through coordination with the USMA Compliance and Training team to ensure appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
  • Act as Subject Matter Expert (SME) for safety related activities per Genentech/Roche SOPs
  • For any identified deviations, responsible for supporting the assessment, investigation, implementation of corrective actions/preventative actions (CAPAs), and development of effectiveness measures.

Competencies Identified for Success:

  • Works effectively, independently and collaboratively
  • Strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment
  • Demonstrates ownership, initiative and accountability
  • Exemplifies strong, dynamic leadership and mentoring skills.
  • Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
  • Excellent communication skills, both written and verbal, with credibility and confidence
  • Sound strategic evaluation, analysis, and decision making skills as demonstrated in effective strategy formulation, tactics and action plans to achieve results
  • Displays a high level of commitment
  • Generates enthusiasm and drive for commitment to excellence

Education, Experience, and Other Requirements:

  • Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety. Candidates with advanced scientific degrees and extensive drug safety experience is highly desired.
  • Minimum of 10 years recent experience in the pharmaceutical industry with 12-15 or more years of experience highly desired.
  • Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
  • Minimum of 5 years experience in management capacity preferably in a comparable drug safety organization.

CMG Operating Principles

I put the patient first, always

I am obsessed with meeting customer needs

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

I am inclusive

I have a growth mindset

I act with urgency

I am accountable

I radically simplify and prioritize for impact

I follow the science

I build our reputation

External Link: https://www.gene.com/careers/commercial-operating-principles

8/3/20 Global HTA Evidence (Analysis) Lead Basel, Basel-City

The Global Access (GA) department at F. Hoffmann-La Roche, Ltd. based in Basel, Switzerland is seeking a Global HTA (Health Technology Assessment) Evidence Lead to join the Global HTA Evidence group within the Access Center of Excellence. This position would report to a Global HTA Evidence Team Enabler.

As a Global HTA Evidence Lead within the Access Center of Excellence (ACE) in Global Access (GA) you will work with colleagues across the global organization (commercial and development) and local market access representatives to develop the HTA Evidence strategies and packages supporting decisions which determine access to Roche’s innovative offerings.

You will collaborate to develop the evidence package used by payers and other Health Technology Assessment bodies to support both the pre-launch and launch stage of reimbursement process. In the pre-launch phase, you will work to identify evidence gaps and data sources, design and execute evidence generation plans, and conduct analyses to address molecule and disease area questions to inform access and the broader integrated business. You will also contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our business and healthcare environments including the application of novel methodologies used to support HTA decision making. This requires a good understanding of integrated access strategies, integrated evidence plans, healthcare environments, affiliate pricing & reimbursement needs, as well as strong scientific and technical expertise. You will need strong strategic, collaboration and communication skills, as well as a solution-driven and entrepreneurial mindset.

This position is required to:

Have the ability to communicate clear integrated access evidence strategies and methodologies and insights derived from evidence used within HTA to diverse audiences. This requires an understanding of the broader context and how evidence can impact access and broader commercialization strategies. Collaborate with colleagues across the organization to provide expertise required for the preparation of evidentiary plans and their application within HTA / reimbursement dossiers. Design and implement HTA evidentiary strategies: developing evidence to support HTA decision making including decision analytical models, network meta-analyses and/or the analysis of clinical trial data.

The role requires collaboration, as the candidate will be expected to work closely with colleagues across the organization (Global Product Strategy, Product Development, and Countries, etc.) to provide expertise used in the preparation of HTA / reimbursement dossiers as well as more broadly implement access and commercialization strategies.

RESPONSIBILITIES

  • Provides input into the design of clinical development programs to ensure evidence needs for HTA are considered within the global development and commercialization strategies
  • Ensures that all functional activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial and others)
  • Actively contributes to best practices and continuous improvement within the HTA Evidence Group
  • Keeps up to date with changing HTA landscape and academic research areas to ensure that current access trends and methodologies are incorporated into evidentiary plans and strategies
  • Lead or contribute to cross-functional sub-teams within an existing global matrix team
  • [for higher levels] Builds and maintains relationships with relevant external health economic, statistics, HTA, and policy experts and contributes to the development of methodologies relevant for HTA and payer activities
  • Plans and executes health economic and/or statistical analyses on clinical trial data and other relevant data sources consideration of the input/feedback from affiliates and global colleagues whilst adhering to industry best practices to support access decision making
  • Develops supportive technical documentation of economic and statistical analyses and supports interpretation of findings with appropriate communication methods
  • Works closely with country-level affiliates to support statistical and health economics input used within their localized reimbursement applications

PREFERRED QUALIFICATIONS/EXPERIENCE

  • Masters or Doctoral level degree in health economics, epidemiology, statistics or a related field with a quantitative focus
  • Expertise in at least one of MS Excel (with VBA), R, SAS, Python, WinBUGS, JAGS or other relevant statistical software
  • Expertise in conducting network meta-analyses (NMA) and/or the application of evolving methodologies in health economic modelling
  • 3 or more years’ with hands-on experience working in a consultancy, academic institution, HTA / reimbursement agency or pharmaceutical industry
  • Strong organization, planning and prioritization skills with an ability to meet tight deadlines
  • Strong written and verbal communication skills in English
  • Team player with a positive mind-set who can work effectively with all key stakeholders (including both local and global colleagues)
  • Extensive knowledge of health technology assessment, clinical research and development methods, and international payer evidence requirements
  • Track record of research publications and other research outputs of high quality is beneficial
  • Previous experience working with evidence to support HTA and market access decision making

If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients’ lives. If you want work in a hardworking team, make your mark & improve lives, apply now.

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

7/31/20 Postdoctoral Research Fellow - Immunology and Infectious Disease, Arron Lab Individual contributor South San Francisco, California

We are seeking a postdoctoral fellow to work on the molecular mechanisms of Notch receptor activation. This position would leverage a suite of unique reagents that selectively target Notch receptors and ligands, crystal structures, as well as relevant cell-based and animal models to elucidate differences in receptor-ligand interactions. The candidate will have the opportunity to apply this knowledge to investigate the molecular interplay between various receptor and ligands in the context of cell-type specification of the lung epithelium during homeostasis, injury, and repair. 

The postdoc will be co-mentored between the Lafkas and Arron laboratories. Genentech has a proud tradition of world-class basic and translational research and the postdoctoral program here allows for important questions about fundamental biological mechanisms to be addressed independently of drug development programs. The large clinical trials conducted by the Roche group gives us unprecedented access to highly clinically characterized patients with matching data on treatment outcome, genetic variants, and disease state. A postdoc will be able to leverage these resources and study biological pathways of interest aided by world-class scientific infrastructure, and also gain exposure to the drug development process.

Qualifications: 

The successful candidate will be a recent or pending Ph.D. graduate with a background in Structural Biology, Biochemistry, and/or Cell Biology. They will also have demonstrated the ability to conduct high-quality research through publications in top tier, peer-reviewed scientific journals.

For information about Joe Arron's lab at Genentech, please go to: https://www.gene.com/scientists/our-scientists/joe-arron

For information about the Postdoctoral Program at Genentech, please go to: https://www.gene.com/careers/university-and-early-career/postdocs

7/31/20 Clinical Education Manager, Respiratory MS/LA Ecosystem Individual contributor Jackson, Mississippi

Title: Clinical Education Manager, Respiratory – MS/LA Ecosystem

Customer Engagement Model

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs.

In order to achieve our vision of delivering ever better health outcomes for patients while lowering overall healthcare costs, we are reinventing our customer engagement model. We started on this journey by listening to our customers, and learning from leaders in customer service in other industries. We learned our customers are inundated with information on new treatment options and are overwhelmed by industry professionals vying for their time. We learned they are also focused on better outcomes at lower costs. And, we learned we are uniquely positioned to partner with many stakeholders across the healthcare system to achieve this goal.

In our new customer engagement model, we are bringing the full value of our portfolio to where healthcare is delivered - locally. No longer will a national strategy supercede local needs.

Each ecosystem has been designed around how patients receive care across the country. The ecosystem team will work together to better understand the needs of the ecosystem and put plans in place to address the needs, as well as identify partnership opportunities to advance our shared goals. And, every leader in our new customer engagement model will add direct customer accountabilities to their leadership responsibilities. We believe this is key in maintaining our customer focus and ensuring our model adapts and flexes over time.

As a member of the ecosystem team, you will be able to fully leverage your skills and capabilities alongside the full Genentech portfolio and our rich and robust pipeline. And, the simplicity of our model allows you to do more for your customers and patients, focusing on what is needed locally while also leveraging best practices from other ecosystems.

Join us as we strive to deliver ever better health outcomes for patients, lower overall healthcare costs and reinvent customer engagement in our industry.

Position Overview

The Clinical Education Manager brings clinical knowledge and expertise to the assigned franchise sales team. The Clinical Coordinator partners with clinical specialists, customers, and patients to increase their knowledge and understanding of the assigned GNE brand(s); their benefits and use as these pertain to the relevant therapeutic area/disease state and approved indication(s).

Example Duties and Responsibilities (not inclusive):

• Participates in territory/division/regional business planning

• Recommends opportunities to increase account knowledge of GNE brand(s)Provides input into marketing materials

• Actively participates in local clinician groups

• Provides training and education sessions regarding GNE brand(s) and their approved indication(s). Uses approved training/education materials

• Partners with clinical specialists in other ways/means by attending periodic account meetings; helping to further increase account knowledge of GNE brand(s)

• Complies with all laws, regulations and policies that govern the conduct of GNE activities

• Business travel, by air or car, is regularly required

Our Operating Principles

I put the patient first, always.

I am obsessed with meeting customer needs.

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

I am inclusive.

I build a culture of trust.

I have a growth mindset.

I act with urgency.

I am accountable.

I radically simplify and prioritize for impact.

I follow the science.

I build our reputation.

Key Competency Profile:

• Communication

• Decision Making

• Inspiring and Influencing

• Teamwork and Collaboration

• Technical and Business Expertise

You are a candidate with the following qualifications and experience: (unless stated as "preferred" or "a plus," all other criteria is required):

• Bachelor of Science in Nursing (BSN) preferred

• Clinical/Medical certification required

• Clinical/Medical certification with graduate-level degree is preferred, e.g., RN with a • Master's Degree in Nursing, or similar qualifications

• Clinical experience in same therapeutic area is a plus

• Average of 5 or more years' work experience

• Previous work or sales-specific experience in the pharmaceutical, biotech, or related industry is preferred

• Bilingual preferred

• Proven track record of meeting or exceeding objectives & goals • Previous experience in achieving specific sales plans or other financial targets is preferred

Roche is an equal opportunity employer.

NOTE: This is a remote position.

 • This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

#LI-TW1

7/31/20 Hemophilia Community Clinical Educator (CE) - North Dakota/Minnesota Ecosystem Individual contributor Minneapolis, Minnesota

Hemophilia Community Clinical Educator (CE)

The candidate must live within the territory. This position is based in ND/MN and it is a field-based role.

Success in this role will require Clinical Educators (CEs) to attend events and meetings during evenings and weekends.  This person is expected to prioritize these events and meetings in order to represent Genentech and support people with hemophilia A and caregivers in their communities.  While work hours are typically not to exceed 40 hours per week, flexible schedules (e.g., comp days) to accommodate evening and weekend work will be operationalized.  The CEs are managed by agreed upon business objectives and are not sales incentivized.

The Hemophilia Community Clinical Educator (CE) Team builds trust in Genentech and provides information and support to people with hemophilia A, caregivers and the community around them.  The CE represents Genentech to the local hemophilia community and leads the following relationships: local advocacyorganizations/chapters, local specialty pharmacy representatives and people with hemophilia A and caregivers.  CEs also interact with healthcare providers in the context of local hemophilia community events and in support of Genentech Clinical Specialists (sales representatives).  The CE provides information and education about Genentech, hemophilia and potential treatment options.

Key Accountabilities

Front-Line Customer Facing Activities

  • Represents Genentech within local hemophilia communities
  • Facilitates, staffs and attends local advocacy events; builds rapport and relationships with advocacy directors and staff at local advocacy chapters to help create a positive, trusted and lasting presence of Genentech in the hemophilia community; engages with local advocacy on programming and marketing-related sponsorships
  • Provides information and educational in-services on Genentech and approved disease and product education to people with hemophilia A, caregivers and the community
  • Ensures positive customer experiences with Genentech by providing ongoing clinical support

Internal Coordination / Collaboration

  • Develops, maintains and executes a territory plan for local hemophilia community (advocacy, local specialty pharmacy, people with hemophilia A/caregivers) including strategic utilization of resources
  • Obtains and maintains full proficiency in disease state, product and business knowledge to support the needs of the community and customer-facing representatives
  • Communicates and aligns principally with Clinical Specialist to determine educational opportunities and priorities
  • Collaborates with home office and customer-facing representatives to align on local priorities and supports needs to achieve results and ensure effective execution

Additional Job Accountabilities

  • Obtains and maintains full proficiency in disease state, product and business knowledge
  • Attends and actively participates in local account team, area and brand calls and meetings
  • Meets administrative expectations consistently
  • Complies with all laws, regulations and policies that govern the conduct of Genentech activities
  • Understands and adheres to HIPAA and all patient privacy policies
  • Demonstrates high ethical and professional standards, and demonstrates Genentech values consistently with all customers and business

Business travel, by air or car, is regularly required; work on evenings and weekends required with flexibility to ensure typically no more than a 40-hour work week

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role.  As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business

Key Competencies

The successful candidate will demonstrate the following competencies critical to this role:

  • Inspiring and Influencing
    • Generates excitement among people with hemophilia A, caregivers, advocacy organizations, local specialty pharmacy representatives and healthcare providers
    • Tailors approach to each customer group
    • “I take a genuine interest in people”
  • Communication
    • Expresses ideas fluently, listens actively, proactively communicates
    • “I listen carefully, tell the truth and explain the why”
  • Teamwork and Collaboration
    • Builds strong, effective relationships with diverse stakeholders
    • Shares ideas, information freely
    • Open to the input of others
  • Achieving Results
    • Track record of achievement and is goal-directed
    • Holds self accountable for meeting commitments
    • Can handle and work through challenges and ambiguity
  • Technical and Business Expertise
    • Nursing/clinical educator, relevant therapeutic area and/or launch expertise
    • Understands and prioritizes customer needs; can translate these into an effective territory plan
    • Passion for patients and education
  • Integrity
    • Upholds high ethical and professional standards
    • Does the right thing (even when no one is looking)

CMG Operating Principles

I put the patient first, always. 

I am obsessed with meeting customer needs. 

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

I am inclusive.  

I build a culture of trust. 

I have a growth mindset. 

I act with urgency. 

I am accountable. 

I radically simplify and prioritize for impact. 

I follow the science.

I build our reputation. 

Background/Experience

  • Clinical/medical certification required
    • Bachelor of Science in Nursing strongly preferred
    • Graduate-level degree is preferred, e.g., RN with a Master's Degree in Nursing, or similar qualification
  • Average of five or more years of work experience
  • Of the three following preferred experiences, at least one is required:
    • Hemophilia, bleeding disorders, and/or rare diseases therapeutic area or launch
    • Previous work or clinical-specific experience in the pharmaceutical, biotech, or related industry
  • Previous work or clinical-specific experience in educating patients and/or caregivers
  • Strong customer orientation and focus
  • Exceptional organizational, communication and presentation skills
  • Proven track record of meeting or exceeding objectives and goals

NOTE:

This is a remote position that requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role.  As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

#LI-MG1

7/31/20 Head of Roche Product Development China Executive (Director/VP) Shanghai

Position Summary:

● Accountable for shaping and evolving an industry-leading Product Development (PD)organization in China on behalf of Roche Global Product Development.

● Establish the PD China strategy in alignment with our Roche Ambition and Roche China 10-year strategy to realize our purpose of serving patients.

● Lead PD China transformation together with PD global transformation and leadership team to grow our organization’s drug development capabilities.

● Lead or provide oversight to the critical interfaces, such as Research Innovation Center Shanghai (RICS), Shanghai Roche Pharma (SRPL), and China Diagnostics, supporting OneRoche to deliver medicines and healthcare solutions to patients.

Development

● Establish and deliver the vision and strategy for PD in China for shaping development and growing our portfolio.

● Collaborate and partner effectively with Research and Early Development, Roche Chinaleadership, and Global Product Development.

● Partner effectively with China research and early development.

● Represent PD China at appropriate forums within Roche and serve on the PD Community of Leaders (CoL) with the PD Leadership Team.

● Serve as an impactful thought leader for drug development in China.

● Serve as ad-hoc member of Late Stage Portfolio Committee (LSPC) for China related topics.

● Lead the China portfolio strategy to maximize the value of the Roche portfolio in China.

● Provide executive input and oversight to ensure China development is optimally integrated in the global development.

● Serve as compliance owner of PD China.

● Create effective external networks and act as an influential industry leader to build forums for helping to evolve the drug development and registration environment in China

Leadership

● Lead & develop the PD functional leaders in China (those who are solid or dotted line reports).

● Maintain and develop a positive organizational culture, by promoting the values of the focus on patients, science, and our people.

● Create a highly stimulating and energizing working environment to ensure our 320+ PD China staff are engaged and motivated, and accomplishments are celebrated.

● Facilitate the PD China Site Leadership Team to ensure that best practices are developed and disseminated.

● Ensure that site focus and activities are aligned with overall PD vision and objectives while also addressing local needs.

● Oversee the PD China management budget.

● Ensure reasonable consistency and alignment with other main PD sites (Basel, South San Francisco, Welwyn, and Mississauga).

● Build a strong PD community fostering cross-functional partnerships and interdependencies.

Competencies:

● Purpose Driven: Communicates a compelling and inspired vision or sense of core purpose and being able to inspire and motivate the PD China organization with growth mindset.

● Leadership: Great ability and passion to lead transformation and building strong connection and collaboration locally & globally. Ability to drive and influence without authority. Effectively lead in a highly matrix environment, across organization functions.

● System thinking: Hold the big picture of enterprise and evolve organizational systems so that we can produce envisioned results; be able to find breakthrough strategies and solutions

● Technical Expertise: MD, Clinician with Drug Development experience.

● Cross Cultural: Relates well to a wide spectrum of people across functions/countries. Knows how to work the different culture and is not afraid of committing to a course of action to get started.

Experience:

● M.D. or M.D./Ph.D.

● Rich clinical drug development experience in a large biotech, pharmaceutical or clinical organization.

● China experience and Mandarin speaking.

● Proven ability to effectively lead in a global, cross-functional matrix organization.

● Ability to work effectively in diverse cultures, showing aptitude in modifying style.

● Successfully leverage external partnerships to achieve key objectives.

● Proven ability to lead innovation and significant change.

● Excellent strategic agility, willingness to experiment and take smart risks.

● Outstanding partnership skills and a superior grasp of the overall business; previous track record includes identifying opportunities that have improved results in areas beyond direct management or influence.

● Strong competitive awareness.

● Outstanding organizational agility and interpersonal savvy: knows how to get things done.

Required to travel internationally.

 

7/31/20 Medical Director/Senior Medical Director, Cancer Immunotherapy Lung Individual contributor South San Francisco, California

GENERAL POSITION SUMMARY/ PURPOSE:

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Medical Director for Cancer Immunotherapy participates in development of the Clinical Development (CD) strategy for atezolizumab and/or tiragolumab and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Medical Directors may have one or more direct reports. PD Medical Directors are expected to perform their responsibilities with more independence by comparison to Associate PD Medical Directors, including participating in health authority (HA) interactions with little to no supervision from their managers.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Cross-Functional Team Leadership & People Management

  • Participates in and/or leads the relevant Clinical Science Team (CST)

  • Can lead and/or otherwise represents CD in sub-teams (e.g. Study Management Teams) relevant to assigned

    molecule(s)/indication(s) and helps ensure cross-functional integration, coordination and alignment to enable effective and

    efficient CD plan execution

  • When assigned/appointed, can act as the Global Development Leader (GDL). Where assigned/appointed, expected

    to represent CD on core teams, e.g., Lifecycle Team (LCT)

  • Accountable for training new CST members

  • May also, as appropriate, support relevant sub-teams in assigning and training new team members

  • As appropriate, participates in ongoing enhancements/development of core and sub-team processes, structures,

    systems, tools and other resources

  • As needed or otherwise appropriate, assists with CD recruitment, training, and/or coaching of new or less experienced CD

    staff members

  • Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training,

    developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures

2. Global Clinical Development Planning

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)

  • As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects

  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease

    area(s) of assignment

  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.

  • Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups

  • May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to

    provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these

  • Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase

    IIIB protocols and other information and provide CD input

  • May also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these

    potentially relate to the assigned therapeutic/disease area(s)

  • Participates in CD strategy development and may present to various internal committees

  • Develops and provides clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the

    Integrated Development Commercialization Plan (IDCP)

  • Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs:

  • o Seeks guidance from his/her manager, as and when needed, to ensure appropriate design and development of the CD plan

  • o Responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCPs
  • o Guides CST and relevant sub-teams in developing all CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
  • o Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
  • Communicates with HAs, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of Roche and patients. Escalates matters, as needed, in a timely manner to his/her manager or other internal partners/stakeholders

3. Clinical Development Plan Implementation

  • Provides clinical oversight across all relevant studies and programs:
  • Leads and/or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and
  • communications
  • Designs and develops clinical studies
  • Collaborates with others in the development of the product safety profile
  • Collaborates with others in development of clinical sections of investigator brochures, presentations and other
  • materials
  • May participate in the identification and selection of appropriate external investigators and sites
  • Guides and collaborates with others on patient registry design and development (including strategies for patient
  • registry recruitment)
  • Acts as CD lead in the development of study analytics and data management plans for each study
  • Represents, alongside his/her manager or others, Roche in key investigator and other external presentations,
  • meetings and other communications
  • Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters
  • relating to each study Acts as a medical monitor for assigned studies
  • Conducts ongoing reviews of medical/safety data
  • Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and
  • plans, including any variances, and proactively communicate any issues, challenges and potential strategies to
  • resolve such
  • Collaborates with other groups to ensure timely and appropriate completion of interim study reporting
  • Collaborates with clinical operations to close-out clinical studies, secure data and complete study reporting
  • Accountable to ensure correct medical/scientific data interpretation for interim and final study reporting
  • Plays a lead role in the development and implementation of communications strategies to support existing and
  • concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  • Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing labeling and packaging language, etc.
  • Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Roche

  • Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment

  • Responsible to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target

  • Completes and/or leads other special projects, as and when assigned, or otherwise requested

  • Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, Roche

    Standard Operating Procedures (SOPs) and other guidelines

 

QUALIFICATIONS & EXPERIENCE:

  • M.D. with relevant medical experience in same/similar therapeutic area required
  • 4 or more years pharma/biotech industry experience OR is a recognized expert in the field
  • 4 or more years experience with clinical trials. In-depth understanding of Phase II – III drug development
  • Experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred
  • Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
  • Experience publishing results of a clinical drug trial in a referred journal is preferred
  • Academic/teaching background is a plusKnowledge/understanding of Phase I & IV drug development is a plus
  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, 
  • competitor data, etc.)Comprehensive understanding of product and safety profiles
  • Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical
  • Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • Familiar with competitive activity in the field
  • Previous people management experience is a plus

ABILITIES:

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
  • Outstanding attention-to-detail
  • Clinical leadership: is regarded as an expert in his/her field, is respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results
  • Business acumen: has sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in thedrug development process. Can effectively contribute to development of disease strategies and plans
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budgetaccomplishment of such
  • Strong interpersonal, verbal communication and influencing skills: can influence without authority and has provenexperience building and cultivating relationships with key partners and stakeholders, both internally and externally
  • Outstanding written communication skills
  • Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points
  • Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focusedand on-point, is able to raise problems or challenges in a productive and mature manner
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment.Consistently and effectively balances decisions with imperatives for ethics and efficacy
  • Strong orientation to teamwork
  • Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
  • Aptitude or proven ability to manage others (can lead and motivate direct reports, as well as prioritize and oversee their workthrough to successful outcomes)
  • Ability to travel globally (<30%)

#NMA

7/31/20 Associate Medical Director - Product Development Oncology (Gynecological Malignancies) Individual contributor South San Francisco, California

Genentech/Roche is seeking an Associate Medical Director to participate in the development and execution of clinical initiatives within the GYN and Breast group in late stage development oncology, specifically on the atezolizumab global development team. Atezolizumab is an anti-PD-L1 anti-tumor immunotherapy agent currently approved in some solid malignancies. It is being actively studied in GYN and breast malignancies.

As Associate Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within the Late Development Oncology organization. You will also participate in developing the long-range strategic plans for the molecule. Important aspects of this role will be the ability to work cross-functionally and cross-organizationally with internal and external stakeholders, be able to work agilely in learning and developing novel clinical trial frameworks to deliver upon the CDP.

Key Accountabilities:

  • Assisting in the overall management, planning, evaluation and documentation of projects and studies. Participation in on-going medicine development activities may include:
    • Developing and writing clinical plans and protocols ensuring scientific integrity
    • Preparation of regulatory documents and interaction with global regulatory authorities
    • Monitoring and reviewing clinical data for safety and ongoing study conduct
    • Analysis, presentation and interpretation of study data, with integrated assessment as compared with published data
    • Participation in the preparation of abstracts, posters and presentations for scientific meetings, congresses, and interactions with Key Opinion Leaders
    • On-going awareness of therapeutic landscape (internally and externally) with ability to to perform rapid assessment and modifications, as needed.
    • Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations​

Qualifications

  • MD with Board Certification or eligibility in Gynecologic Oncology or Hematology/Oncology and clinical practice experience required as well as strong scientific competence demonstrated by peer reviewed publications or production of clinical expert reports.
    • Minimum of 3 years experience in clinical research required with experience in the pharmaceutical industry preferred, or deep expertise in GYN malignancies in an academic research setting
    • Past work experience of confirmatory drug development and evidence of having played a significant part in the preparation of international regulatory submissions and work with health authorities a plus; exceptional candidates without this level of experience may be considered on an individual basis
    • Work with health authorities in outcomes measures, presentations, negotiations and submissions are important
    • Demonstrated ability to interact effectively in a multifunctional multinational team setting

  • To be successful in this role, you will have the following skills and experience:
    • Solid experience in medical research
    • Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents
    • Good communication and collaborative skills with experience at working with cross-functional and external groups, including researchers, clinicians and other stakeholders
    • Proven track record of delivery of experimental or novel studies
    • Confidence at presenting at internal and external strategy meetings

 #NMA

7/31/20 Postdoctoral Research Fellow - Cancer Signaling, Lill and Dey Labs Individual contributor South San Francisco, California

We have an open position for a talented, highly motivated Postdoctoral Research Fellow to join the laboratories of Dr. Jennie Lill (Proteomics & NGS) and Dr. Anwesha Dey (Discovery Oncology). This will be a joint appointment focusing on the utilization of molecular biology, biochemistry, proteomics and informatics to study the role of the Hippo pathway in cancer.

The successful candidate will have experience in cellular experiments using cell lines (FACS, IP Western signaling experiments, CRISPR) and will have strong computational skills and be familiar with working with large omics datasets. Experience working with mouse models or mass spectrometry/proteomics is a plus.

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

For information about the labs of Jennie Lill and Anwesha Dey at Genentech, please go to: https://www.gene.com/scientists/our-scientists/jennie-lill

https://www.gene.com/scientists/our-scientists/anwesha-dey

Who You Are

The qualified individual will possess a Ph.D. in Biochemistry, Developmental Biology, Biochemistry, Molecular or Cell Biology or related fields with a solid publication record. The candidate should have experience dissecting intracellular signaling pathway analyses using a range of biochemical, molecular biology and computational skills.

Excellent communication and writing skills as well as a record of accomplishment of working in highly collaborative environments is essential.

The successful candidate must be able to demonstrate scientific rigor and a willingness to collaborate with a highly multi-disciplinary team of scientist. Additional expectations include publication of research in high-quality scientific journals.

How to Apply

To apply for this position prior to August 6th, we would like a copy of your resume including the names of three current references. We also require a two paragraph long proposal, proposing a study of your choice to help further elucidate signaling mechanisms associated with the Hippo pathway.

7/31/20 Medical Director, Product Development Oncology Breast (GDC9545) Individual contributor South San Francisco, California

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Associate PD Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient CD plan execution for the assigned molecule(s)/indication(s). Associate PD Medical Directors participate in health authority (HA) interactions with supervision from more experienced PD Medical Directors.



1. Cross-Functional Team Membership

• Participates in the relevant Clinical Science Team (CST)

• Participates as a standing 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 with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution

• As requested, supports the CST lead and overall team with training new CST members

• May also, as appropriate, support relevant sub-teams in training new team members



2. Global Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)

• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects

• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.

• Participates in CD strategy development

• Supports other CST members with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)

• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science development input and guidance. Includes reviewing Phase I protocols and providing CD input into these

• Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input

• As assigned, may also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)

• Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs to include gathering and analyzing data and information necessary to create the CD plan, working with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.) and working with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan

• Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients

3. Clinical Development Plan Implementation

Provides clinical support across all relevant studies and programs:

• Participates in ongoing CST and relevant sub-team meetings, except Development Working Group (DWG), other interactions and communications

• Designs and develops clinical studies for review and discussion with other CST members

• May collaborate with others in the development of the product safety profile

• Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials

• May participate in the identification and selection of appropriate external investigators and sites

• May assist others with patient registry design and development (including strategies for patient registry recruitment)

• Collaborates with others in development of study analytics and data management plans

• Participates in investigator and other external presentations, meetings and other communications

• May support clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions

• Acts as a medical monitor for assigned studies

• Conducts ongoing reviews of medical/safety data

• Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such

• Supports, as needed, completion of interim study reporting

• Works closely with other CST members and clinical operations to close-out clinical studies, secure data and complete study reporting

• Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting

• Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials

• Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.

• Develops presentations for other CST members to deliver to convey the CD perspective and provide updates on strategies, plans and other activities

• Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment

• Completes other special projects, as and when assigned, or otherwise requested

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

QUALIFICATIONS & EXPERIENCE:

• M.D. with relevant medical experience in same/similar therapeutic area required

• 2 or more years pharma/biotech industry experience OR is a recognized expert in the field

• 2 or more years experience with clinical trials across Phase II – III drug development

• Academic/teaching background is a plus

• Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)

• Experience developing product and safety profiles

• Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

ABILITIES:

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

• Outstanding attention-to-detail

• Has working knowledge of the multi-disciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.

• 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 (<30%)

 #NMA

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