Jobs in Alameda, CA

SUMMARY: The Field Based Marketing Director on the Key Customer Team role is a field-based position focused on working closely with Key Opinion Leaders (KOLs) at select institutions and accounts within the defined geography. This person is the Exelixis products and services expert for Key Opinion Leaders and ensures that cross-functional resources are made available as appropriate to this key customer segment. In this role, you are a member of the GI Marketing Team and you will work closely with field sales and other members of the Commercial Team at the home office. You will be instrumental in creating the brand strategy for key customers and the tactics that will drive it across. You will also ensure successful execution of the key opinion leader strategy and tactics. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist in the creation of the content for commercial tactics including the promotional speaker bureau and the content for advisory boards. Identify profile, cultivate and maintain long-term relationships with KOLs tracking opinions and behaviors. Lead the development of Key Account engagement plans for each assigned KOL for the commercial team. Manage KOL engagement plans at congresses for the commercial team. Play a key role in enabling and influencing the understanding and opinion of diseases, mechanisms of diseases, and the potential role of Exelixis products in the management of these diseases using on-label and approved marketing material. Act as the primary liaison between KOLs and home office cross-functional teams. Assist in the execution of Advisory Boards. This may involve identifying, recommending, and inviting potential advisors, moderators and speakers, preparation of faculty, participation in meeting and report out to functional teams. Assist in the development of promotional speaker bureaus which may involve speaker identification and recruitment, attending and supporting speaker training meetings. Additional follow-on speaker training activities may be required to ensure accurate and effective presentations of Exelixis products. Work closely with KOLs to obtain feedback to be considered in the development of brand strategies. Complies with all laws, regulations and policies that govern the conduct of Exelixis activities. SUPERVISORY RESPONSIBILITIES: There are no direct supervisory responsibilities for this job. EDUCATION/EXPERIENCE/SKILLS: Education: MA/MS degree in related discipline desired and 11 years of related experience; or BA/BS degree in a related discipline with at least 13 years of related. Equivalent combination of education and experience. Experience: Field-Based/Regional Marketing experience. Oncology therapeutic area experience. Launch experience. Knowledge/Skills/Abilities : Expert knowledge of relevant products, their associated therapeutic areas, competitors and other related marketplace factors. Knowledge of KOLs and compliant KOL development practices. Strong organization, planning, and analytical skills. Demonstrated project management skills with the ability to manage multiple projects simultaneously. Ability to work independently to execute against strategic and tactical plans under tight timelines. Ability to assemble and lead cross-functional teams toward a shared vision of success. Ability to present ideas effectively to individuals or groups, targeting presentation to the needs of the audience. Ability to lead, mentor and on-board newer members of the team. Ability to travel to meetings/trainings/programs as necessary. Valid driver's license. Must reside within the geographic area of the assigned territory. ~65% travel required. Job Complexity : Works on problems of diverse scope and impact where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Netwo

SUMMARY/JOB PURPOSE: The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of solid tumor oncology clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL). *** This position is located at Exelixis beautiful headquarters overlooking the bay in Alameda, CA. Full relocation provided ESSENTIAL DUTIES AND RESPONSIBILITIES: * Manages clinical trials, including those conducted through Contract Research Organizations (CROs) * May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams * Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab) * Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight * Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation * Coordinates the preparation, conduct, and presentations at Investigator Meetings * Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials * Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.) * Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines * Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed * Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP) * Ensures oversight of regulatory and essential documents * Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Coordinates the design, format, and content of study guides and subject instructions * May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC) * May support / be responsible for site and vendor invoice reviews * Reviews and provides oversight of study trackers and metrics * Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc) * May be responsible for department strategic initiatives or process improvements * May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS) SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or, * PhD/PharmD in biological sciences or related field and zero or more years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research Knowledge/Skills: * Experience in either starting a study up, maintenance phase, or study close-out * Experience with development of prospective site-selection criteria * Protocol development experience * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidel

SUMMARY/JOB PURPOSE: Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies. Assists senior regulatory leaders with the development of documents to support desigations and other health authority programs and requirements, health authority responses, and global regulatory planning. ESSENTIAL DUTIES AND RESPONSIBILITIES: Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Track safety reports and coordinate submissions to US INDs. Assist Project Team Regulatory Representative in preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence. Assist with developing and implementing strategies to ensure compliance with HA requirements. Respond to requests for information from regulatory bodies. Serve as liaison with FDA. Work collaboratively with consultants and contractors to accomplish regulatory activities and submissions. Contribute to department initiatives. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of seven years of related experience; or, Master's degree in related discipline and a minimum of five years of related experience; or, PhD degree in related discipline; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Knowledge/Skills: Works independently and with others to contribute to plans, complete tasks and achieve results within established timelines. Takes pride in delivering high quality work. Gathers, maintains and applies regulatory knowledge to complete routine work. Provides verbal and written communications that are clear and easy to understand. Provides timely and appropriate information updates to departmental management and colleagues. Good interpersonal skills, understanding of differing views; participates in reaching an agreed upon resolution. Works collaboratively with team members to achieve common objectives. Applies knowledge of organizational objectives and adopts an analytical approach to solve problems relevant to the role. Leads self by managing and executing own work, acts with integrity and builds trust with colleagues. JOB COMPLEXITY: Capable of following predefined procedures for specific tasks. Capable of identifying task-related challenges and prioritizing activity accordingly. Identifies and escalates issues that may have a broader impact. Implements solutions to address any task-related challenges. WORKING CONDITIONS: Travel approximately 10% #LI-MB1 Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $126,000 - $179,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives

SUMMARY/JOB PURPOSE (Basic purpose of the job): The Packaging Engineer I is responsible for providing technical oversight of pharmaceutical packaging operations at Contract Manufacturing Organizations (CMOs). The qualified candidate will have technical knowledge of packaging operations and have some experience in overseeing pharmaceutical packaging operations at external CMO's. Additionally. the qualified candidate will possess excellent interpersonal skills to effectively work in a team-based environment. ESSENTIAL DUTIES/RESPONSIBILITIES: Provide on-site/remote technical support for project activities such as commercial packaging, implementation/qualification of new packaging line equipment and introduction of components changes. Work as "person-in-plant" to oversee routine commercial packaging operations at CMOs as needed. Utilize technical expertise to trouble-shoot packaging process issues. Provide support for packaging serialization implementation. Review and approval of Master Packaging Records and executed packaging batch records, protocols and reports. SUPERVISORY RESPONSIBILITIES: Oversight of work at external CMOs. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in related discipline and a minimum of 1 year of related experience; or, Equivalent combination of education and experience. Experience: Experience with packaging operations for pharmaceutical products. Experience providing CMO on-site technical support, including oversight of packaging issues and investigations. Experience working with internal and external partners. Knowledge, Skills and Abilities: Demonstrates proficiency with broad use computer applications such as MS Office and specialized applications as needed. Has some understanding of labeling and packaging operations including artwork, bottle filling, blistering, cartooning, printing and serialization. Performs a variety of complicated tasks with a wide degree of creativity and latitude. Has good understanding of technical principles, theories, concepts and techniques for packaging. Applies strong analytical and business communication skills, be able to present data and results concisely per relevant audience. Environment: primarily working in laboratories or in office. Work Environment/Physical Demands : Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. Travel required - 15% of domestic/international travel required. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. We are an

SUMMARY/JOB PURPOSE: Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy and marketability of compounds. Projects, prepares the statistical component of protocols which meet project objectives, guidelines and clinical trial methodology standards. Essential Duties And Responsibilities: Provide written and verbal recommendations on quantitative/statistical and data management issues. Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines. Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated. Review ADaM specifications and verify primary and secondary efficacy endpoints. Assist in performing data analysis, interpretation of study results, and may collaborate with clinical team to produce interim reports, final reports, and publications. May interact with and manage counterparts at CROs or companies collaborating with Exelixis. Interpret the project implications of regulatory guidelines. Supervisory Responsibilities: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/BA degree in related discipline and 7 years of related experience; or, MS/MA degree in related discipline and 5 years of related experience; or, PhD in related discipline and 0 or more years of related experience; or, Equivalent combination of education and experience. May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: Typically requires a minimum of 3 years of related experience and/or combination of experience and education/training. Knowledge/Skills: Expertise with SAS and or R programming is preferred. Developed and or reviewed SDTM/ADaM specifications. Experience in Oncology or similar related discipline. Knowledge of FDA/EMA regulations and guidance documents. Problem solving skills, and sound statistical judgment. Attention to detail. Ability to effectively represent Biostatistics in multidisciplinary meetings. Ability to interact effectively with Biostatistical, data management, operations, and clinical personnel from CRO and companies collaborating with Exelixis. Uses knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. Performs a variety of task under only general direction. Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results. Has good general knowledge of other related disciplines. Applies good analytical and business communication skills. JOB COMPLEXITY: Works on difficult problems where analysis of situations or data requires a thorough solution. Exercises judgment within generally defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining solutions. Uses professional concepts and company's policies and procedures to solve a range of difficult problems in imaginative and practical ways. Networks with key contacts outside own area of expertise. #LI-JP1 Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $130,500 - $186,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretiona

SUMMARY/JOB PURPOSE: The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL). ESSENTIAL DUTIES AND RESPONSIBILITIES: * Manages clinical trials, including those conducted through Contract Research Organizations (CROs) * May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams * Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab) * Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight * Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation * Coordinates the preparation, conduct, and presentations at Investigator Meetings * Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials * Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.) * Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines * Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed * Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP) * Ensures oversight of regulatory and essential documents * Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Coordinates the design, format, and content of study guides and subject instructions * May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC) * May support / be responsible for site and vendor invoice reviews * Reviews and provides oversight of study trackers and metrics * Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc) * May be responsible for department strategic initiatives or process improvements * May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS) SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or, * PhD/PharmD in biological sciences or related field and zero or more years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research Knowledge/Skills: * Experience in either starting a study up, maintenance phase, or study close-out * Experience with development of prospective site-selection criteria * Protocol development experience * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures * Familiar with advanced concepts of clinical research * Ability to deal

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SUMMARY/JOB PURPOSE: The Clinical Supplies Manager II oversees all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners/vendors to ensure supply of IMP are sufficient at depots and clinical sites. Essential Duties And Responsibilities: Lead effort for clinical supply management functionality. Monitor and manage clinical supply activities through IRT from study start-up through study closure. Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO's for assigned studies, ensuring the project timeline is met or exceeded. Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases. In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan. Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials. Work cross-functionally to develop IRT to develop specifications and perform UAT. Design and/or review label text to meet product requirements and ensure compliance with US and international regulations. Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners. Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Ensure appropriate system documentation is transferred to TMF and ready for inspection readiness. Utilize appropriate software and IT systems to effectively manage key project activities. Supervisory Responsibilities: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/BA degree in related discipline and a minimum of seven years of related experience; or, MS/MA degree in related discipline and a minimum of five years of related experience; or, Equivalent combination of education and experience. Certification in assigned areas is a plus. Experience/The Ideal for Successful Entry into Job: Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution. Clinical Supply management experience using contract manufacturing companies strongly preferred. Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS Knowledge/Skills: Willingness to work in a fast paced, evolving environment. Knowledge of GMP batch record development, review, and approval processes. Knowledge of Interactive Voice/Web response systems for use in clinical studies. Working knowledge of regulations relating to clinical labeling, packaging and distribution activities. Working knowledge of GMP/GCP/GLP regulations required. Excellent project management and communication skills. JOB COMPLEXITY: Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise. Working Conditions: 20% travel to vendor sites, team meetings, and/or other offices. Work Environment/Physical Demands: Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. #LI-MB1 Our compensation reflects the cost of labor across severalU.