How do changes in genome sequence affect biological function and disease? We cannot assay billions of mutations, but evolution has already tested the impact of changing every base in our genomes. Comparative genomics now offers a key to break this ‘evogenetic code’ by exploring which mutations survived evolution and how they correlate with the rest of the genome and on the biology of the organism.

We are looking for a smart, skilled, and highly motivated postdoctoral fellow to lead our exploration of genome evolution by reconstructing ancient genome sequences and modeling mutation patterns and evolutionary constraints. This will have potentially profound implications on understanding human sequence variation (familial and somatic), on understanding protein functions, and on relating genomics to organismal biology.

Our postdoc training encourages exposure to multiple projects, and we also have remarkable opportunities in the integrated analysis of cancer genomes. The Department of Bioinformatics and Computational Biology at Genentech is one of the largest bioinformatics research groups with a remarkable breadth and depth of expertise, a strong team environment, deep links to our research colleagues, and a uniquely strong opportunity to help develop breakthrough new medicines. The Manning lab (http://manninglab.org/) focuses on understanding of biological function and disease through evolutionary genomics analysis.

Summary of Position:

The Compliance & Training associate reports directly to the Manager, Compliance & Training. This individual will work closely with the US Drug Safety staff to support all safety-related activities accountable to US Drug Safety.  In addition, interactions US Medical Affairs Compliance will also occur on an as-needed basis. 

Job Duties/Responsibilities:

• Training of vendors and other 3rd parties to drug safety reporting requirements
• Working with commercial organization to ensure monitoring of Genentech sponsored websites for adverse event reporting
• Oversight of US Drug Safety audit and inspection findings and CAPAs
• Oversight of US Drug Safety local procedures and controlled documents
• Management of US Pharmacovigilance & Safety Data Exchange agreements 
• Management of US Drug Safety global pharmacovigilance commitments
• Monitor IT issues
• Management of special projects
• Track US pharmacovigilance metrics
• Conduct vendor assessments for AE reporting compliance
• Interact, where applicable, with US Medical Affairs Compliance to address safety-related issues or concerns

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

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

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

·         Participates in the identification of appropriate external investigators

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

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

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

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

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

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

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

·         May also participate/coordinate collaborations with external stakeholders

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

approved clinical projects.

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

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

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

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

Act as the main point of contact between Solution Owners, Project Managers and the Operations Support team in the release or implementation of new services, applications or products into production. Ensures smooth transition of new Operational Services and provides implementation support for the Regions

• Ensures tools, processes and procedures are in place to enable the Regions to support new services, applications and products
• Coordinates with the AE&O Support Processes & Continuous Improvement team and the Regional Account Managers on the release and design of new services, applications and products into production 
• Develops methods to track and monitor the Service Health and provide initial reporting
• Acts as the main point of reference and is consulted in Operational AE&O IT projects that impact the tools, processes and technologies used in the Operational Teams in the support of AE&O provided services
• Develops Training material for new Services in collaboration with the solution owner and coordinates the Trainings with the Regional Account Managers
• Assists the Site Implementation Team during the integration of new sites or acquisitions to ensure Processes, Training and Regional/Local Support is in place.   
• Coordinates with the Support Processes & Continuous Improvement Team, the AE&O operational Teams and the Regional Account Managers to ensure tool and Process availability for a upgrade to an existing service, new service release or implementation 
• Ensures and coordinates knowledge base updates with any required information to support a release or implementation
• Ensures Training material availability on new processes and procedures and coordinates Trainings in cooperation with the Regional Account Managers
• Reviews project plans with the Solution Owner or Project Manager for transition planning and provide feedback to ensure a smooth release or implementation.
• Provides reports and monitoring on the impact of releases and implementations on the AE&O operational Teams and the Regional and Local support teams and drives improvements until normal operations are achieved
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• Works with Solution Owners and Project Managers to ensure that requirements of the Operational Teams and the Regional/Local Support teams are represented and understood
• Ensures efficient processes for Operational and Supporting teams and establish an aligned incident escalation chain to reduce escalations. 
• Push automation opportunities for request and change management, reduce escalation of incidents by enforcing Knowledge management usage and validation of KM data.
• Establish early reporting and Service Health metrics with trending information on incidents, requests and changes. 

The ERP Portfolio and Demand Management Coordinator position provides non-technical support primarily to the North American based ERP (Enterprise Resource Planning) team, within the Shared Platforms and Applications area of Pharma Informatics. The global ERP team consists of approximately 180 team members, 50 of which are based in our SSF office. The ERP team mainly supports the business application areas of SAP, Business Warehouse and ARIBA.

This SSF-based position is within the ERP Portfolio and Demand Management team. The ERP Portfolio and Demand Management team is responsible for many important cross-functional topics, such as financial management, demand planning and communication, supporting and advising project managers, process implementation and compliance, audit co-ordination and tracking, metrics and reporting, as well as adhoc management support requests. We support the various managers, project managers and application teams to ensure consistency and efficiency across the ERP Department. 

As part of this small team, you will have a varied and challenging role, working on cross-functional topics while interacting with team members in Basel as well as colleagues other functions (e.g. Finance, Procurement, HR).

You will have the following key responsibilities:

• Support the required financial processes, including the coordination of the budget and monthly outlook events and monitor the budget versus actual spend. Proactively support and advise the SSF based activity owners and project managers on financial topics
• Provide the required financial reports and updates, accurate and timely organizational information and recommendations to ensure the ERP department stays within the given budget
• Support the ERP Team, being the point of contact and advisor for the North American based ERP team with day to day business processes to ensure efficiency and accurate information flow (e.g. purchase order creation and processing, payment of invoices, checking accuracy of accruals, etc.). Advise team members in order to resolve issues in a timely way.
• Manage key relationships and liaise with other departments as required, e.g. Finance, Procurement, HR.
• Support the ERP Team with the needed tools and processes to manage the ERP portfolio of work, which will enable the ERP department to meet the needs of their customers.
• Participate in or lead small projects/initiatives as needed to ensure implementation of common process and tools (e.g. Resource management, Customer satisfaction surveys) and provide ongoing support to the ERP Department
• Assist the Portfolio and Demand Management team establish and report on metrics required by the ERP Solution Owners
• Support and assist with the ongoing improvement of Collaboration tools, such as Touchpoint.

The Senior Scientist, in vivo pharmacology, will lead a translational research group focused on immune-mediated oncology therapeutics. The successful candidate will work closely with other disciplines within Genentech to drive research stage programs into early clinical development, providing scientific and strategic leadership, and technical management. The individual must be motivated to work in a scientifically rigorous, fast-paced environment to achieve key results that drive program decision-making. The ideal candidate will have an in-depth understanding of immunology, cancer biology and animal models with a strong publication record.

Summary of Key Responsibilities:

• Lead translational research group primarily supporting tumor immunotherapy programs.
• Develop experimental strategies to define/validate the mechanism of action and mechanism of resistance of immune-mediated anti-tumor therapeutics.
• Provide in vivo pharmacology expertise to project teams during the discovery and development phases of biologics and small molecule drug discovery programs.
• Define PK/PD/efficacy relationships in collaboration with colleagues within DMPK and research oncology.
• Develop innovative preclinical animal models that enable interrogation of mechanisms of action, diagnostic hypotheses, and mechanisms of resistance.
• Direct management of up to 5 research associates, in vivo and in vitro. Develop and assess goals of direct reports.
• Responsible for authoring documents to support regulatory filings and patent applications.

Product Manager / Senior Product Manager 

 
Managed Care Marketing (MCM) supports Genentech’s business by designing managed care marketing strategies, plans and programs for Genentech’s pipeline and in-line portfolio that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices).

For pipeline products, MCM supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Senior Product Managers are generally responsible for multiple molecules at various stages of development.

For in-line products, Senior Product Managers act as a primary liaison to managed care account managers (for payer and channel customers) and field reimbursement managers (FRM) (for practices) and may have matrix responsibilities to represent MCM for one or more products or franchises.
 
Product Manager / Senior Product Manager responsibilities may include:

Overall

• Creates and delivers managed care marketing strategies and programs; manages relevant agencies and budgets
• Works with US and/or Global cross-functional groups to ensure a seamless and well-integrated messages and overall positioning across multiple marketing platforms
• Aligns therapeutic area and managed care marketing strategies and tactics with pricing, reimbursement, contracting, distribution and other relevant functions
• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year brand strategies and tactical plans
• Educates internal partners and stakeholders on the US managed care landscape and its implications to current and future managed care marketing strategies, plans and objectives
• Continuously refines knowledge of internal and external business drivers of the managed care landscape and their implications for Genentech
• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall results
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

For pipeline molecules

• Leads managed care strategic planning to contribute to Phase III drug development investment decisions, trial design, and overall value proposition
• Builds, implements and manages the managed care marketing plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (as relevant)

For in-line products

• Acts as a key liaison to managed care customer-facing teams and to relevant brand teams
• Works with various MCCO account management teams to effectively and efficiently apply branded and non-branded promotional resources or other relevant resources to accounts, as appropriate 
• Provides strategic consultation to account management-led account planning
• Reviews and assesses cross-functional business strategies, plans and tactics; recommends managed care marketing strategies, plans and activities that support optimal positioning and reimbursement of and access to Genentech medicines
• Creates and manages 3-year and 1-year managed care marketing strategies, plans, and tactics for specific managed care segments
• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives.

Responsibilities: This position is for a Validation Engineer I/Manufacturing Technical Specialist I - Validation reporting to a Manager of Technology Validation in the South San Francisco Production Technology Department.  The candidate will be responsible for Validation scope supporting the South San Francisco manufacturing plants.  This includes drafting and execution of validation protocols, authoring validation and technical reports and development of project plans.  In addition, the candidate will support technical assessments for quality impact and participate on quality investigation teams.  The candidate will also monitor maintenance of the validated state of basic and some complex equipment and processes.  This includes monitoring operations and resolving moderate validation issues.  The candidate will support introduction of clinical products into manufacturing by participating on campaign/product planning teams and delivering the appropriate validation activities consistent with project timelines.  The candidate may lead cross functional teams or projects.  The candidate will be expected to work effectively in teams, to influence others to generate support for assigned activities or projects and to justify goals to department colleagues.  They will also act as a mentor for those with similar or less validation expertise.

This position is responsible for providing leadership and direction to a purification process development group in Purification Development.  The candidate will lead a team of 12-18 staff comprised of several groups of scientists and engineers and be responsible for the management and leadership of multiple early stage and late stage development and technology projects.  A high degree of initiative is expected to assess new areas and directions critical for Pharma Technical Development and Genentech’s future success.  Strong management skills to lead, motivate, and develop staff in their group is a key requirement for this position.  The candidate is expected to provide leadership to their groups and throughout Purification Development and across Pharma Technical Development.

The Genentech Research and Early Development (gRED) Clinical Trial Manager (CTM) provides support and/or leadership to one or more global Study Teams within an early development program(s). The CTM is accountable for activities ensuring high quality deliverables are within budget and timelines.  

Primary Accountabilities and Responsibilities:

• Support cross-functional Study Team within Clinical Operations with minimal oversight from the Sr. CTM and/or CPL

• Responsible for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budget

• Responsible for vendor selection and management including CRO, IVRS, central lab and imaging vendor

• Provide input to the study budget and is responsible for managing assigned vendor budget(s)

• Under the leadership of the Sr. CTM, takes responsibility for agreed operational aspects (e.g., vendor management, drug supply management)

• Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate

• Partner with CPL to develop and/or present at project teams and management review bodies

• Conduct protocol and site feasibility assessments

• Provide support, mentoring, and study-specific training to Clinical Operations staff

• Network and share best practices with colleagues to ensure optimal efficiency and consistency in Clinical Operations

• Participate in initiatives and/or activities as assigned

Responsibilities and Accountabilities When Leading a Study:

Depending on skill level and study design, CTM may lead Study Team, including obtaining agreement on project timelines, study objectives and goals.

• Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines

• Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets

• Provide input to the program budget and is accountable for managing overall study budget

• Delegate and oversee study activities assigned to Clinical Operations Study Team as applicable

• Provide drug supply assumptions to clinical planning team

These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual.

CDM Process Analyst

Performs tasks described in previous job level and additional tasks as specified below:

1. Represents CDM PTM within the Biometrics community

2. Provides guidance on CDM best practices and compliance based upon existing controlled documentation

3. Facilitates the development and refinement of CDM processes

4. Adjudicates comments to ensure the process reflects current business practices

5. In collaboration with subfunctional managers, develops, reviews and updates job role training qualifications

6. Liaises with PDQP regarding the creation and ongoing maintenance and training of processes

7. Serves as the single point of contact at the respective sites to the Inspection Readiness Coordinator

8. Recommends process improvements based on other companies and industries through literature review, attending professional conferences and direct sharing of information

9. Ensures document consistency

10. Acts as change and transition agent during new process implementation

11. Develops and maintains standard tools and templates to support Clinical Data Management processes

12. Ensures job role training qualifications are in alignment with industry

13. Challenges and supports Clinical Data Management staff to critically review

current processes for effectiveness, quality and simplification

14. Provides mentorship to less experienced Process Analysts

15. Provides guidance and oversight to PTM contractors

16. Contributes or leads local and subfunctional working groups and initiatives

17. Leads or participates in the local functional/crossfunctional implementation of best practices and process improvement initiatives

18. Is responsible for complex deliverables for the subfunction for one or more projects

19. Effectively communicates ideas, project goals and

status of work and independently presents at department meetings

20. Identifies and develops solutions to complex problems

21. Sets targeted timeframes for deliverables and anticipates potential scenarios that may create timeline delays

22. Is able to influence and negotiate a positive outcome

23. Evaluates probability, impact and priorities of risks and develops and implements mitigation plan

24. Articulates functional knowledge in the development of subfunctional processes, training and related documents

25. Partners with PTM Training community to ensure best training practices are being leveraged in process training

The Preclinical and Translational PK/PD Department at Genentech,Inc. is seeking a Ph.D. level scientist who is driven to understand the pharmacokineticsand pharmacodynamics of novel drug candidates with a focus on proteintherapeutics including antibody drug conjugates. This individual will beresponsible for investigating the pharmacokinetics, biodistribution, and PKPDrelationships of novel therapeutics in preclinical models to identify leadcandidates for further development, and for all relevant translational aspectsbridging preclinical PKPD information to patients. This individual will beresponsible for the PK and PKPD strategy to support preclinical development andfirst in human regulatory filings, including planning, designing, analyzing, interpretingand reporting PK and PKPD studies. This will be accomplished by working inclose partnerships across various functions including Research, DevelopmentSciences, Clinical Sciences, Biostatistics, and Regulatory. This individualwill represent the department on cross functional project teams as the PKPDrepresentative and/or pharmacology sub-team leader. An additional componentwill be the presentation of PK/PD results at cross-functional teams, departmentmeetings, review committees, conferences and regulatory meetings.

Senior Project Manager – IT

The Senior IT Project Management position will be responsible for leading the delivery of technology projects in support of US Commercial Operations. The Senior IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology. The Senior IT Project Manager will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The Senior IT Project Manager will be accountable for all projects in the Commercial Compliance Solutions portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers. 

Duties:

* Define, plan, and direct the execution of a broad range of technical projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Identify, acquire, and lead multifunctional project teams

* Manage a portfolio of projects, in addition to individual projects assigned to the position

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

* Manage relationships with various technology and business communities to achieve 

project objectives

* Facilitate project management activities across the entire project management methodology

* Establishes and maintains effective communication for assigned projects and with dependent projects

* Ensure successful and timely completion of deliverables

* Track progress against baseline schedule

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

* Identify and apply systematic quality activities to ensure that projects employ all 

processes needed to meet Computer System Validation directives

* Suggest improvements where necessary / appropriate to improve operational efficiencies

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

* Formulate risk mitigation strategies and recommend solutions

* Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems

* Other duties as assigned

A multi-talented Informatics specialist in San Francisco is needed for the Global Pharma Informatics Safety Risk Management team. In this role you will work closely with the Business System Owner, users, development and support teams, vendors and service providers to provide an excellent service for the Drug Safety Systems globally. 

A true multi-talented professional is required – willing to play multiple roles as required within a dynamic global team – to ensure optimal support, service and application delivery to our internal customers.  You will act in multiple capacities such as service manager, solution life cycle manager and business analyst. Activities you are likely to be doing in this role are (but not limited to):

• Ensure Support globally is seamless and following our Global Support Model  - your primary responsibility will be the users in the Americas (North, Latin and South America), however you and your team may need to deal with critical incidents not resolved by the team located in the EU.
• Work in close collaboration with other Delivery Service Managers to ensure global support and prioritization of incidents and assignments
• Work closely with business users, business system owner and informatics to keep all stakeholders abreast of any significant impact and changes to the systems.
• Ensure the validated state of our systems and ensure compliance with applicable SOPs and policies governing the systems and processes.
• Provide business process support by understanding existing business processes, and offering advice, implementation of changes or reconfiguration to meet business objectives.
• Provide technical support and trouble shooting for our Safety Risk Management applications.
• Work in collaboration with business to identify business solutions and requirements for new functionalities, and performing impact analysis on systems and processes, and potential ongoing projects
• Work with vendor/service providers to ensure compliance with SLAs and support in service improvement initiatives.
• Develop excellent relationships with all layers of business
• Participation in systems projects
• Openness to take on new tasks and challenges outside the formal role description corresponding to skills and capacity

MSDs are generally expected to perform their responsibilities with limited guidance from Medical Directors and/or other relevant internal partners and stakeholders:

·         Implement the medical affairs plan for the assigned drug(s) /indication(s), working with Medical Directors, mainly on PhIV clinical programs and their publication plans

·         Collaborates with Commercial and provides scientific input for the development and review promotional materials, documents and presentations developed for the assigned drugs and/or indications (signing off of any promotional material remains the responsibility of the Medical Director of the assigned drugs and/or indications)

·         Support his/her manager, as and when requested, in developing relevant parts of the medical affairs tactical plans, and/or completing other special projects such as preparation and review of training materials for field forces

·         Demonstrate ever-increasing competence in implementations of all aspects of medical plans

·         Competently and collaboratively interact with a host of internal and external partners and stakeholders

·         Consistently complete all assigned responsibilities on-time and on-target.

·         Develop and cultivate important relationships with internal and external partners and stakeholders. Includes investigators, thought leaders and KOLs (key opinion leaders)

·         Stay informed and abreast of the external landscape as it relates to assigned drugs and/or indications and the associated therapeutic area(s)

JOB DESCRIPTION - PRIMARY DUTIES AND RESPONSIBILITIES:

1. Clinical Trials & Programs 

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

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

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

·         Participates in the identification of appropriate external investigators

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

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

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

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

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

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

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

·         May also participate/coordinate collaborations with external stakeholders

(e.g...

The PD Clinical Operations / Biometrics / Clinical Science Informatics team (part of FPPO) is looking for a senior Business System Analyst (BSA), with in depth Business analysis experience in the Pharma/Biotech industry and the ability to strategize, recommend and implement solutions with an end-to-end process filter that will meet the short and long term needs of Clinical Operations.

The senior BSA is responsible for exploring, scoping, planning and supporting the successful implementation of solutions by providing business analysis, best practice research, detailed requirements definition and user acceptance facilitation.

We are looking for an individual with strong customer focus, experience in working in global, multi-cultural environments, with a structured working approach and excellent analytical and communication skills. 

FURTHER RESPONSIBILITIES / DUTIES ARE:

• Participate and conduct strategic / exploratory workshops to identify / plan / execute innovation experiments and to contribute to robust roadmaps supporting the business strategy. Example: resource may participate to the Trial2Patients initiative 
• Collaborate with business and informatics stakeholders to lead business case development for new initiatives as well as business case tracking for completed initiatives.
• Plan early stage project efforts; specifically, requirements gathering, assessment and scoping, and project initiation and funding.
• Plan and facilitate workshops and end-user working sessions intended to surface requirements and validate designs.
• Take active role in preparing initiatives for portfolio committee and approvals at appropriate project milestones.  
• Collaborate with other BSMs / BSAs across functions and regions to identify and address business problems and opportunities, evaluate alternative informatics technologies and research industry best practices and emerging trends.
• Collaborate with Project Managers, Architects, Engineers, Developers, and Designers on scope, solutions, constraints, and risks
• Analyze document current and future business process models
• Take responsibility in ensuring the solution meets the customer needs. Support operational services teams in ensuring continued business value realization and business adoption.
• Collaborate with BSMs / BSAs within function and across functions to continuously harmonize and further develop skills and working practices specific to the BSM/BSA community within the organization 

The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes.  Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.

Responsibilities:

The areas of major responsibility include, but are not limited to the following:

• Responsible for the day-to-day operations of the designated Medical teams.

o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules

o Co-leads and facilitates all medical team planning and decision-making

o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.

o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.

o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.

o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics 

o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements 

o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution

• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.

• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc. 

• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution 

• Conducts proactive risk assessment and change control for all assigned projects/programs

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