Clinical and Clinically Related Jobs

Manage preparation of stand-alone contracts with internal contractors. Collect documents, compile work order and finalize the execution of the documents through contract signature.
During the budgetary exercise, support Clinical Program managers (CPM’s), Clinical Program Manager Global Head, and Global Heads of functional platforms in estimating the outsourcing budget using internal tools and metrics.
Develop expertise in current systems (e.g.,OPX2, SAP, NEXTS) and any new systems that may be require to support CPM responsibilities.
Manage the CPM database (structure, upgrade, data entry) and support CPM’s and Global CPM Head in providing reports to upper management.
Work in collaboration with staff from functional platforms to capture operational information.
Participate in review of contracts relating to Sanofi Pasteur’s pipeline, pending or existing change orders, outstanding invoices and payment issues.
Process and manage invoices from the various vendors. This includes data entry of invoices, verifying that the information on the invoice is accurate and has been approved by the authorized official and ensuring compliance with the approved budget.

EXPERIENCE AND QUALIFICATIONS:

Strong expertise with WORD, EXCEL, and Powerpoint
Experience with SAP and other ARIBA tools
Ability to work in a multidisciplinary team
Bachelors degree in Life Science or related field of study or Purchasing
Post-college or graduate experience in an Outsourcing or Purchasing department in the pharmaceutical industry preferred
Budgetary and contract experience is preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

2) Sr. Director, Clinical Operations – Full Time Position (San Francisco Bay Area) JI16G

DESCRIPTION:

Reports to the VP of Clinical Operations.
The Director/Senior Director will lead all the Clinical Study Teams (CST’s) to achieve clinical studies deliverables working with both in house and CRO Clinical Program Managers and CRA’s.
Oversee program level execution of all Clinical Development and Clinical Operations deliverables, and leads the Clinical Operations team to meet the clinical department goal and objectives.
Represent clinical operations on the Project Teams.

Primary Responsibilities:

Initiate and lead clinical study teams as clinical director. Responsible for the successful operations of all study teams to achieve the study objectives at the highest standards and on time and budget. He/she will assist in protocol writing to completion, site selection, and working with internal managers/CRA’s and CRO’s depending on the study to deliver patients, data, analysis, up until finalization of Clinical Study Report (CSR). All tasks and activities will be conducted full compliance with regulatory requirements, GCP, good medical practice, and SOP’s.
Supervise all study activities, with the CST team members in terms of study initiation, the data collection activities, and site management. Monitors adherence to protocols and study timelines.
Identifies program risks; proactively creates and implements mitigation strategies. Provide Sr. Management with necessary reports on progress and changes in scope, schedule and resources in a timely manner including preparation of presentations and documents to the R&D Strategy Committee (RDSC)
Works with internal team members in the development and implementation of compliance programs for Clinical Trials, including SOP’s.
Manage high performing teams of Clinical Program Managers and CRA’s to achieve their goals and objectives as it relates to the different clinical studies objectives. Must be able to manage and develop people
Develop relationships with key thought leaders to support product development, he or she will represent the company externally in applicable scientific and medical forums. Must be able to manage and develop people. Performs job duties with minimal guidance and has sound critical thinking and problem solving skills.
Travel approximately 20% of the time

EXPERIENCE AND QUALIFICATIONS:

Minimum MS. Ph D or Pharm D is preferable.
Minimum of 10+ years managing clinical science/operations/development in a pharmaceutical and/or biotechnology company demonstrating a broad background in those environments.
Minimum of 5+ years of experience managing other clinical operations/development staff. Ability to manage the needs of multiple internal and external partners and deploy resources to meet those needs.
Prior Experience managing oncology or hematology trials is a must.
Knowledge of key opinion leaders in the areas of oncology/hematology will be highly valuable.
Familiar and comfortable with clinical concepts, practices and FDA regulations regarding clinical research trials. Also familiar with data processing methods, general knowledge of clinical medicine, oncology, and medical terminology.
A superb manager, will possess the ability to interact with and train clinical monitors and physicians investigators and build constructive, trusting and respective relationships with people at all levels within and outside the organization.
Excellent leadership, performance management, communication skills and strong organizational skills.

To apply for a position send your resume to Jobs@JGBBioPharma.com

3) Sr. Director, Clinical Development – Full Time Position (San Francisco Bay Area) DJ16G

DESCRIPTION:

Reports to the Chief Medical Officer and work collaboratively with the Clinical Study Team contributing to the strategic planning and execution of Clinical Development Plans for all company compounds in clinical development.
Responsible for the design of clinical study concepts and writing of clinical trial protocols; responsible for the medical/scientific supervision of individual clinical trials and accountable for all deliverables of clinical trials under her/his direct responsibility.
Assume medical monitoring role to clinical trials.
Provide medical input into clinical trial strategies and define clinical trial-related clinical development program goals and objectives.
Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts based on thorough scientific review and consultation with internal and external experts.
Work cross-functionally to define, plan and implement phase 1 studies through clinical proof of concept.
Extensive interactions with academic thought leaders to optimize clinical trial strategies.
Collaborates with Medical Writing department in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports and clinical study reports. Will be the primary person responsible for the clinical content of all clinical and regulatory documents.
Identifies program risks, creates and implements mitigation strategies with Clinical Operations.
Responsible for analysis of clinical data, including safety monitoring in collaboration with Drug Safety.
Leads and supervises the work of the Clinical Study Team to produce high quality program deliverables.
Contributes to clinical development advisory boards and safety monitoring boards.
Ensures Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines.

EXPERIENCE AND QUALIFICATIONS:

MD Board Certified in Oncology/Hematology is strongly preferred.
An MD with training in Oncology/Hematology, with a minimum of 10 years of clinical trial experience, particularly in early stages of development, of which, at least 5 years in the industry setting.
Experience leading the design, content, analysis and reporting of oncology clinical studies is strongly desirable.
Significant successful interactions with oncology key opinion leaders/investigators.
Demonstrated the capability for strategic planning along with operational skill and experience related to clinical research involving both single and multiple centers.
Ability to work across multiple functions is essential.
Effective oral and written communication skills and strong leadership are strongly desirable competencies for this role.

To apply for a position send your resume to Jobs@JGBBioPharma.com

4) Clinical Research Assistant (CRA) – Full Time Position (San Francisco Bay Area) 55SSB

DESCRIPTION:

Maintain an accurate inventory of the regulatory and other study documents including maintaining the Trial Master File and associated study files.
Review regulatory documents for accuracy, working with clinical trial sites and CRAs to resolve discrepancies.
Create and maintain database for investigators, financial disclosure, IRB approvals, etc.
Maintain study related tracking.
Assist in planning of internal and external meetings including investigator meetings and data safety review boards.
Organize and distribute internal and external project reports.
Keep inventory of project supplies; assemble and ship supplies to sites as needed including study drug.
Assist in preparation of study binders, personnel lists, and site manuals.
Assist the CRA/SCRA/CPM in co-monitoring visits as required to review the study files at the study sites, and to facilitate data retrieval.

EXPERIENCE AND QUALIFICATIONS:

Similar job title and function for a minimum of 6 months
Bachelor’s degree in science preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

5) Director, Health Economics & Outcomes Research (Full time position, San Francisco Bay area) S28BS

DESCRIPTION:

Develop and execute research strategies to proactively address health care provider and payer needs for clinical, economic and humanistic evidence (patient-reported outcomes). Position reports to the Senior Director, Epidemiology & HEOR.

Design and lead research studies of clinical trial, external patient-level, and session-level data
Internally, work closely with biostats, clinical development, and medical affairs medical directors to perform analyses in clinical trial databases. Additionally, work closely with data strategists and programming analysts to perform analyses in large claims and HCP clinical databases
Externally, partner with external research organizations and vendors on proposed analyses/projects of external patient and session-level databases
Across all data research studies (internally or externally), actively lead and collaborate to formulate hypotheses and ensure appropriate study methods and rigorous study design are being used. Evaluate, interpret, and communicate study results while ensuring quality of studies; be able to identify and discuss biases and limitations which may impact the interpretation of the data.
Design and lead research studies of external databases while partnering with external research organizations and vendors on proposed analyses/projects. Actively collaborate to ensure appropriate methods are being used, including formulating hypotheses, rigorous study design and analysis and interpretation and communication of results
Be able to generate deep insights and understanding of strategic implications of scientific work
Maintain awareness of U.S. regulations governing promotional claims for health economics, keep abreast of current changes in HEOR.
Maintain awareness of and update organization on the current state of research and literature on relevant topics.
Identify data sources which are efficient and appropriate for research questions.

EXPERIENCE AND QUALIFICATIONS:

PhD in epidemiology, medical informatics, health economics, biostatistics or other related field; or MD/MPH or MD/PhD degree.
A minimum of 10 years in the pharmaceutical/biotech industry in medical affairs, epidemiology, HEOR, biostatistics, secondary market research, or consulting firms within these areas.
Demonstrated acumen in presenting scientific data to internal cross-functional audience, senior management and external audience required.
Experience with health economics and outcomes research. Epidemiology and/or biostatistical background a plus.
Experience with kidney disease a plus.
Demonstrated success working with and/or managing projects using patient level datasets;
Understanding of U.S. regulations governing promotional claims for health economics
Experience and demonstrated success managing outside/contract vendors as well as collaborations with partners.
Proven negotiation, influencing and collaboration skills.
Ability to think strategically and translate strategy into action. Strategic agility and flexibility in dynamic environment crucial.

To apply for a position send your resume to Jobs@JGBBioPharma.com

6) (Sr) Clinical Regulatory Scientist – Full Time Position (San Francisco Bay Area) G62RG

DESCRIPTION:

Provides Regulatory Leadership to deliver a global regulatory strategy for highly complex products. Responsible for communication and teamwork with project team members and development partners.

Main Purpose of the Position:

Responsible for the development and implementation of regulatory strategies to facilitate the development and ultimately, approval of drugs/biologics for human use. Serves as the primary liaison with regulatory authorities and manages the strategy and execution of these interactions. Responsible for communication and teamwork with project team members and development partners.

Job Duties/Responsibilities:

Serves as the US Regulatory Leader on highly complex/business critical projects
Serves as the regulatory representative on multiple projects and represents a complete regulatory strategy, including
CMC and Commercial and leads the regulatory subteam
Leads the lifecycle team and regulatory sub-team in developing, implementing and delivering a global regulatory
strategy for highly complex products
Provides regulatory due diligence assessments in cooperation with business development
Presents regulatory strategies and issues at corporate committees/senior management
Serves as the primary liaison with regulatory authorities
Manage projects within a 6-12 month planning horizon
Demonstrate leadership in defining novel approaches to product development and approval
Collaborate with senior management on relevant long-term regulatory strategies to ensure effective achievement of
regulatory/business objectives
Exerts influence in the development of overall objectives and long-range goals
Makes sound, independent decisions which may have long-term impact
Lead cross-functional teams in the coordination of regulatory submissions
Work collaboratively with business partners
Leads and participates in department initiatives, task forces, and training
Provide leadership in researching, recommending and implementing new processes in the department/company
Continues to expand knowledge base of laws, regulations and guidelines governing the development, licensure and
marketing of drugs and biologics
Provides direction to Associates/Sr. Associates working on their projects through a matrix structure
Occasional travel

EXPERIENCE AND QUALIFICATIONS:

Business knowledge
Leading innovation and change
Strategic agility
Minimum Bachelor’s degree; advanced degree in science preferred
Minimum of 10 years drug development in Regulatory Affairs or related experience
Strategic agility, ability to work well under pressure, influence at all levels without authority, strong interpersonal
Relationship building, work in a team environment, flexibility and willingness to adapt in a changing environment
Demonstrate leadership, sound decision-making, negotiation and problem solving skills in an independent manner
No relocation is provided for this position.

To apply for a position send your resume to Jobs@JGBBioPharma.com

7) Clinical Pharmacologist – (6 month contract, San Francisco Bay area) G68SO “on-hold”

DESCRIPTION:

The individual will support all phases of drug development and program design by providing specialized guidance and direction regarding all aspects of Clinical Pharmacology. As a senior contributor to the clinical department, is accountable for and may oversee the development and recommendation of novel clinical study designs and clinical strategies. This individual will lead design of novel clinical study designs and clinical strategies for determination PK, DDI, PK/PD and POP/PK for respective compounds and ensuring quality, timely, and cost-effective project deliveries.

The successful candidate will have the ability to integrate clinical and non-clinical considerations for drug metabolism, pharmacometrics, and toxicology data to assist in the development of the clinical pharmacology strategy of compounds. The candidate will work to advance multiple compounds by integrating PK/PD and clinical data to evaluate/simulate optimal doses/regimens, exposure-response, exposure-safety analyses, etc. to support the clinical pharmacology section of product inserts.

Provide expert Clinical Pharmacology advice in all programs.
Design and write clinical PK protocol synopses, PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions.
Able to work independently to analyze, interpret and apply new clinical data to refine the PK development plan.
Ability to assess results from standard PK software (e.g., WinNonlin, NONMEM), proficiency in the use of such programs in not required.
Actively participate in cross-functional and clinical teams by promoting clinical pharmacology, explaining/defending the PK strategy and data analyses, and providing PK deliverables according to timelines.
Draft, contribute to, and review presentations for professional meetings.
Vendor management with CRO and other parties to oversee design development and execution of studies

EXPERIENCE AND QUALIFICATIONS:

PhD, MS, PharmD degree in pharmaceutics, pharmacology, pharmacokinetics,.
Must have a comprehensive understanding of principals of clinical pharmacokinetics and pharmacodynamics from at least 5-10 years of clinical pharmacology/pharmacokinetic drug development and data analysis experience in a CRO or clinical group of a pharmaceutical company.
Excellent oral and written communication skills required.
Understanding of Good Clinical Practice.
Demonstrated ability to work effectively with people and to lead teams is essential.
Ability to collaborate with cross-functional and external teams.

To apply for a position send your resume to Jobs@JGBBioPharma.com

8) GCP Inspection Specialist – Full Time Position (San Francisco Bay Area) S62BG

DESCRIPTION:

The Inspection Specialist supports our Company’s organizations by coordinating, managing, and preparing for Good Clinical Practice (GCP), Pharmacovigilance (PV), and Investigator Site inspections conducted by global health authorities. This position is in the Quality department.

Major Responsibilities and Accountabilities

Coordinates scheduling and logistics for inspection related activities.
Collaborates with other Pharma functional areas for activities related to inspection preparation. Activities include, but are not limited to, preparation of relevant materials and conducting inspection related training.
Participates in pre-inspection visits of investigator sites.
Participates in health authority inspections and helps ensure that roles and responsibilities have been defined and assigned for each inspection. Assumes a role as required by the scope and nature of the inspection.
Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
Assists in the preparation, conduct and management of mock inspections conducted of our Company’s functional areas.
Assists in developing and maintaining policies, standard operating procedures (SOPs), and guidelines for preparation and conduct of inspections within our Company’s Pharma.
Assists in preparing periodic summary reports and trend reports related to company inspections.
Develops and maintains expertise in international GCP regulatory requirements, international PV regulatory requirements, and policies, SOPs and project-specific procedures within Pharma applicable to the clinical trial methodology and Pharmacovigilance processes.
Monitors trends in health authority inspection activities to proactively identify potential areas of risk for the company.
Responsible for the coordination of Inspection Readiness (IR) modules and if required provides a country-specific /function-specific summary report.
Provides support to the IR Program Manager.
Provides support to and communicates with Inspection Readiness Key Contact (IRKC) personnel globally.
Assists in identifying needs for updates to training materials, IR modules and all documents required for the IR program.

EXPERIENCE AND QUALIFICATIONS:

Minimum of a Bachelors degree in a scientific or health-related field with at least 5 years of relevant industry experience
Minimum of 2 years in quality assurance/compliance required with a working knowledge of GCP and PV regulations.
Prior auditing and/or or health authority inspection experience highly desired.
General computer proficiency (e.g., Microsoft Office Suite applications).
Proven project management skills
Ability to work both independently and in a team environment
Strong communication skills; verbal and written
Critical thinking and decision-making skills
Detail-oriented with the ability to prioritize, organize, plan and manage multiple tasks efficiently
Prior participation in GCP and/or PV inspections is desirable
GCP experience required for consideration.

To apply for a position send your resume to Jobs@JGBBioPharma.com

9) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) T16GL

DESCRIPTION:

Study conduct of ongoing Phase 1 trial in 10 US centers, and study start up for Phase 2 trial in 10 centers. Design, plan and implement the overall direction of clinical research projects. Draft and participate in the development of relevant documents for Phase 1 through 3 studies including protocols, informed consent forms, CRFs, study manuals, monitoring plans, data management plans, abstracts, presentations, and manuscripts. Assist in compilation of investigator brochures, under close supervision.

Assist in the preparation of safety, interim and final study reports.
Monitor (perform site visits for data collection and resolution of data discrepancies, source data verification, and review of regulatory documents/files, if applicable) or co-monitor with CRO/regional CRAs as required.
Assist in site selection, study implementation and ongoing management of study sites either directly or via service providers.
Participate in forecasting study drug supply requirements and managing logistics.
Build and maintain CRO/service provider relationships.
Coordinate and/or participate in Investigator meetings.
Interact with investigators for protocol development, presentations and publications.
Train study coordinators and investigators on Good Clinical Practice/ICH
Participate in the development of best practices for Phase 1 through 3 study management.
Requires minimal direction to determine methods and procedures on new assignments.
Domestic Travel up to 25%.

EXPERIENCE AND QUALIFICATIONS:

A BS or BA in a relevant scientific discipline and minimum 4 years related experience in the pharmaceutical industry or equivalent.
Must have experience managing service providers, including Contract Research Organizations (CROs), and coordinating the work of regional CRAs
Oncology experience is required
Ability to travel up to 25% in the US
Working knowledge and experience with Outlook, Word, PowerPoint and Excel.
Working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
Must demonstrate strong attention to detail, meticulous follow-through, and the desire to thrive in a fast paced environment.

To apply for a position send your resume to Jobs@JGBBioPharma.com

10) Clinical Research Associate/Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) R40DG

DESCRIPTION:

Oversees the conduct of assigned clinical studies including acting as liaison to clinical investigators & ensuring the quality and integrity of data. This position will independently perform clinical monitoring activities to ensure site compliance and adherence with study protocols, project plans, company SOPs, and FDA/ICH GCP regulations.

Responsibilities include but are not limited to:

Conduct Site Qualification, Site Initiation, Interim Monitoring, Site Close-out, and other study-specific visits including the completion of trip reports and follow-up letters after each visit
Verify that the investigator has adequate qualifications and resources including facilities, laboratories, equipment, and staff to safely and properly conduct the trial. Confirms that qualifications and resources remain adequate throughout the trial period
Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File
Ensuring the sites are adequately prepared and trained to participate in the clinical trial
Ensure that the investigator receives the current Investigators Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s)
Verify investigational product is handled according to the regulations
Report site status and develop a patient recruitment plan in conjunction with the site.
Verify that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial
Determine whether all adverse events (AEs) are appropriately reported within the time periods required by Good Clinical Practices (GCP), the protocol, the Ethic Committees (IRB/IEC), the sponsor, and the applicable regulatory requirement(s)
Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations
Maintain current, accurate and complete tracking tools and provide status updates including essential documents, monitoring visits, CRF collection, data entry, query status, SAE reporting, subject screening and recruitment, supplies inventory, and overall project timelines and budgets.
Prepare essential document packages for sites and review the completed site essential document packages for accuracy, completeness, and compliance with GCP. Ensure site essential documents are up to date, working with the CRA to collect documents from sites.
Maintain and ensure quality of the Trial Master File including tracking, review of documents and filing.
As needed, assist the Project Managers in the implementation of clinical projects by gathering information concerning therapeutic areas; reviewing protocol synopses and protocols; assisting in the generation of study specific case report forms, source documents and other study tools; identifying investigators and assessing their suitability; assisting in the management of clinical trial medications and supplies; interacting with service providers; scheduling and documenting team meetings, and assisting investigative sites with regulatory documentation.

EXPERIENCE AND QUALIFICATIONS:

BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent experience
Minimum of 5 years on-site monitoring experience
Oncology background or experience is preferred
Ability to travel approximately 25% travel based on study demands
Good working knowledge of GCP/ICH Guidelines and all monitoring responsibilities
Formal certification as a Certified Clinical Research Associate (CCRA) is highly desirable
Effective written communication skills and computer skills are required

To apply for a position send your resume to Jobs@JGBBioPharma.com

11) Clinical Research Associate/Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) R54OH

DESCRIPTION:

Responsibilities include but are not limited to:

Conduct Site Qualification, Site Initiation, Interim Monitoring, Site Close-out, and other study-specific visits including the completion of trip reports and follow-up letters after each visit
Verify that the investigator has adequate qualifications and resources including facilities, laboratories, equipment, and staff to safely and properly conduct the trial. Confirms that qualifications and resources remain adequate throughout the trial period
Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File
Ensuring the sites are adequately prepared and trained to participate in the clinical trial
Ensure that the investigator receives the current Investigators Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s)
Verify investigational product is handled according to the regulations
Report site status and develop a patient recruitment plan in conjunction with the site.
Verify that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial
Determine whether all adverse events (AEs) are appropriately reported within the time periods required by Good Clinical Practices (GCP), the protocol, the Ethic Committees (IRB/IEC), the sponsor, and the applicable regulatory requirement(s)
Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations
Maintain current, accurate and complete tracking tools and provide status updates including essential documents, monitoring visits, CRF collection, data entry, query status, SAE reporting, subject screening and recruitment, supplies inventory, and overall project timelines and budgets.
Prepare essential document packages for sites and review the completed site essential document packages for accuracy, completeness, and compliance with GCP. Ensure site essential documents are up to date, working with the CRA to collect documents from sites.
Maintain and ensure quality of the Trial Master File including tracking, review of documents and filing.
As needed, assist the Project Managers in the implementation of clinical projects by gathering information concerning therapeutic areas; reviewing protocol synopses and protocols; assisting in the generation of study specific case report forms, source documents and other study tools; identifying investigators and assessing their suitability; assisting in the management of clinical trial medications and supplies; interacting with service providers; scheduling and documenting team meetings, and assisting investigative sites with regulatory documentation.

EXPERIENCE AND QUALIFICATIONS:

BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent experience
Minimum of 5 years on-site monitoring experience
Oncology background or experience is preferred
Ability to travel approximately 25% travel based on study demands
Good working knowledge of GCP/ICH Guidelines and all monitoring responsibilities
Formal certification as a Certified Clinical Research Associate (CCRA) is highly desirable
Effective written communication skills and computer skills are required
The individual must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity.

To apply for a position send your resume to Jobs@JGBBioPharma.com

12) Senior Clinical Research Associate II (SCRA) – Full Time Position (San Francisco Bay Area) Z55BZ

DESCRIPTION:

Reports to Clinical Program Manager (CPM).
May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
May write protocols and protocol amendments, with supervision
Will present at investigator meetings
May manage CROs and/or contract CRAs with guidance from CPM
Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
Assist in setting and updating study timelines
Participate in abstract preparation, presentation preparation and manuscript development
Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree in a relevant scientific discipline or equivalent
At least 5.5 year of relevant experience as a CRA in the biotech / pharmaceutical (not diagnostics / device) industry in an in-house (not Regional monitor, CRO or Hospital / Site based position).
Phase 3 experience, Study start-up experience, and Global trial experience are desirable
Must have some experience with direct monitoring of sites (in order to manage the CRO; direct monitoring is not part of this job)
Experience in a start-up environment preferred
Knowledge of GCP and ICH guidelines
Ability to work collegially within a team
Able to perform routine assignments with general instructions and new assignments with detailed instructions
Must be able to go on occasional travel (this is an in-house position so very little travel is expected)
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Basic Relocation Provided

To apply for a position send your resume to Jobs@JGBBioPharma.com

13) (Senior) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R55BS

DESCRIPTION:

Clinical Program Manager to manage multiple clinical trials.

Reports to an (Associate) Director, Clinical Operations
Manage late stage global clinical study teams, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
Manage CRA to SCRA level clinical operations personnel

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree in a relevant scientific discipline or equivalent
At least 7 years of relevant clinical experience in the pharmaceutical industry or equivalent with 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 1 year prior experience as a CPM preferred
1+ years managing staff/direct reports preferred
Must be hands on and used to a start-up environment
Knowledge of GCP and ICH guidelines required
Proficiency in the implementation, monitoring, and management of clinical trials
Able to work collegially within a team and carry out duties/responsibilities with general instructions
Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
Must be willing to travel occasionally (this is an in-house position so very little travel is required)
Previous experience as a CPM managing more than one trial in Phase 3 or a large Phase 2B trial
Study start-up experience is highly desirable
Global (Asia, Europe, South America, Middle East, or Africa) trial experience is highly desirable
Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
Basic relocation provided

To apply for a position send your resume to Jobs@JGBBioPharma.com

14) Clinical Research Associate II (CRA II) – Full Time Position (San Francisco Bay Area) LS55B

DESCRIPTION:

Reports to Clinical Program Manager (CPM).
May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
May write protocols and protocol amendments, with supervision
Will present at investigator meetings
May manage CROs and/or contract CRAs with guidance from CPM
Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
Assist in setting and updating study timelines
Participate in abstract preparation, presentation preparation and manuscript development
Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree in a relevant scientific discipline or equivalent
At least 1 year of relevant experience as a CRA in the biotech / pharmaceutical (not diagnostics / device) industry in an in-house (not Regional monitor, CRO or Hospital / Site based position). 3+ years CRA experience is preferred;
Must have some experience with direct monitoring of sites (in order to manage the CRO; direct monitoring is not part of this job)
Knowledge of GCP and ICH guidelines
Excellent communication and interpersonal skills
Ability to work collegially within a team
Able to perform routine assignments with general instructions and new assignments with detailed instructions
Must be able to go on occasional travel (this is an in-house position so very little travel is expected)
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Relocation from within California provided but local candidates are preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

15) Manager/Senior Manager – Quality GCP Compliance (San Francisco Bay Area) B30US

DESCRIPTION:

As a member of the Quality team, this position is the primary liaison between QA and Clinical providing GCP (Good Clinical Practice) oversight and QA support to the Clinical group.

Manage the GCP audit program by ensuring appropriate plan, schedule, conduct and report of audits, coordination of audit follow-up including CAPA and corrective action
May develop and implement GCP training.
Work with the QA team to develop and implement system for compilation of audit data, verification and retrieval for trending and reporting.
Contribute to the development of the company’s QA concepts and principles and to achieve objectives in creative and effective ways.
Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
Exercises independent judgment in developing methods, techniques, and evaluation criteria in obtaining results.
Reports to Senior Director, Global Quality Assurance

MAJOR DUTIES OF POSITION:

Partner with the Clinical Department to help assure that all clinical trials are assessed for compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
Manage schedules, site visits and audits of clinical research organizations (CROs) to assure compliance with all applicable regulations and standards.
Collaborate with Clinical stakeholders, including but not limited to, Medical Affairs personnel, study teams and investigative sites. Provide guidance and feedback on regulations and best practices.
Coordinate, develop, maintain, and/or deliver GCP training programs.
Stay abreast of current regulatory enforcement trends and regulatory changes. Update Standard Operating Procedures (SOPs) or provide feedback on appropriate policy changes to align corporate policies and practices with regulatory updates. Implement training on changes as needed.
Perform internal audits and report to management significant compliance risks in the GCP area including periodic metrics, analysis and interpretation of audit findings. Provide recommendation to mitigate risks as appropriate.
Assist in resolving compliance issues and assessing impact of any deficits.
Create, review, and follow internal SOPs, to comply with US, EU, and Canadian requirements.
Represent Quality Assurance at meetings, and communicates compliance strategy and risks.
Operate within the limits of approved quality agreements with CROs.
May travel to perform GCP audits or site visits.
Support the site during regulatory inspections and provides QA expertise and assistance to other departments as required.
Maintain a work environment that fosters respect, open communication, collaboration integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:

BS/BA degree in a scientific or health-rated field with 8 years of progressive experience in the Pharmaceutical and/or Biotechnology industry with at least 2 years’ GCP experience at the manager level.
Knowledge of applicable FDA, EU and ICH regulatory requirements for GCP.
Proven experience in clinical compliance or clinical quality assurance.
Experience in managing and conducting compliance audits including leading internal process audits is required.
Must be an effective communicator and proven abilities to communicate complex information and concepts with clarity, including flexibility in approach to problem-solving, negotiating, and trouble-shooting issues and problems.
Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team-orientation and the ability to work independently.
Ability to effectively prioritize and manage multiple projects and tasks.
Highly ethical, flexible, action and goal- oriented; works well under pressure, and is effective in meeting tight deadlines.

To apply for a position send your resume to Jobs@JGBBioPharma.com