Careers

Overview:

The Clinical Research Associate assists with all operational activities within the clinical research department. S/he will work closely with the Associate Director, Clinical Operations as well as Research & Development, Regulatory, Contract Research Organizations (CROs), internal Project Managers and other outside consultants and contractors to assist with the effective design, execution and reporting of Phase I-III clinical studies. This position is accountable for consistent compliance with Good Clinical Practices, including management of CROs who may be assigned partial or complete clinical study activities during drug development. The individual in this position will work on projects in multiple therapeutic areas, both in the U.S. and overseas.

Summary of Key Responsibilities:

1. Establish appropriate processes and procedures to conduct clinical trials, including support for clinical programs in Type 2 diabetes mellitus, Hepatitis C and possibly other indications.
2. Plan resources and tasks to meet corporate goals for timely initiation and completion of clinical studies.
3. Assist in establishing/implementing systems for tracking of various activities, processes and procedures during clinical trials, e.g., data warehousing, clinical reviews, data query resolution, drug supply, budgets etc.
4. Interact with and supervise CROs.
5. Assist in setting up, negotiating, planning and monitoring of budgets for clinical operations as needed.
6. Collaborate with CROs in evaluating clinical study sites and coordinate and conduct site audit activities as necessary.
7. Monitor or co-monitor clinical sites to ensure that the study is conducted in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements
8. Track enrollment of clinical studies.
9. Support the preparation of clinical sections of regulatory submissions.
10. Help maintain appropriate Standard Operating Procedures (SOPs) for the department and assuring staff training (in collaboration with Regulatory).
11. Respond to audits and data queries.
12. Assist in reviewing and revising protocols as required.
13. Develop, review and revise informed consent form templates as required.
14. Develop study documents such eCRF templates and eCRF completion guidelines, study procedures manual, and develop and review source document templates.
15. Other duties as assigned by the Associate Director, Clinical Operations.

Required Skills, Knowledge, Abilities and Qualifications:

1. Degree in science or science related area (minimum BA, preferred MS).
2. Approximately 3-5 years of relevant industry experience supporting clinical programs (preferred therapeutic areas: metabolic, infectious disease).
3. Ability to travel to clinical study locations: may require domestic travel up to 30% at peak times and some international travel as required by the project.
4. Live in San Diego area.
5. Prior success with oversight of CROs, hands on monitoring experience, and supporting clinical study sites and IRBs.
6. Working knowledge of U.S. and ICH GCP regulatory requirements.
7. Experience in early stage programs, late stage programs is a plus.
8. Excellent written and verbal communication skills with attention to detail.
9. Creative problem-solving and critical thinking skills.
10. Prior experience in small company environment is a desired.
11. Team player that operates easily in an informal but fast-paced biotech environment.

Overview:

The Clinical Research Associate assists with all operational activities within the clinical research department. S/he will work closely with the Associate Director, Clinical Operations as well as Research & Development, Regulatory, Contract Research Organizations (CROs), internal Project Managers and other outside consultants and contractors to assist with the effective design, execution and reporting of Phase I-III clinical studies. This position is accountable for consistent compliance with Good Clinical Practices, including management of CROs who may be assigned partial or complete clinical study activities during drug development. The individual in this position will work on projects in multiple therapeutic areas, both in the U.S. and overseas.

Summary of Key Responsibilities:

1. Establish appropriate processes and procedures to conduct clinical trials, including support for clinical programs in Type 2 diabetes mellitus, Hepatitis C and possibly other indications.
2. Plan resources and tasks to meet corporate goals for timely initiation and completion of clinical studies.
3. Assist in establishing/implementing systems for tracking of various activities, processes and procedures during clinical trials, e.g., data warehousing, clinical reviews, data query resolution, drug supply, budgets etc.
4. Interact with and supervise CROs.
5. Assist in setting up, negotiating, planning and monitoring of budgets for clinical operations as needed.
6. Collaborate with CROs in evaluating clinical study sites and coordinate and conduct site audit activities as necessary.
7. Monitor or co-monitor clinical sites to ensure that the study is conducted in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements
8. Track enrollment of clinical studies.
9. Support the preparation of clinical sections of regulatory submissions.
10. Help maintain appropriate Standard Operating Procedures (SOPs) for the department and assuring staff training (in collaboration with Regulatory).
11. Respond to audits and data queries.
12. Assist in reviewing and revising protocols as required.
13. Develop, review and revise informed consent form templates as required.
14. Develop study documents such eCRF templates and eCRF completion guidelines, study procedures manual, and develop and review source document templates.
15. Other duties as assigned by the Associate Director, Clinical Operations

Required Skills, Knowledge, Abilities and Qualifications:

1. Degree in science or science related area (minimum BA, preferred MS).
2. Approximately 6-8 years of relevant industry experience supporting clinical programs (preferred therapeutic areas: metabolic, infectious disease).
3. Ability to travel to clinical study locations: may require domestic travel up to 30% at peak times and some international travel as required by the project.
4. Live in San Diego area.
5. Prior success with oversight of CROs, hands on monitoring experience, and supporting clinical study sites and IRBs.
6. Working knowledge of U.S. and ICH GCP regulatory requirements.
7. Experience in early stage programs, late stage programs is a plus.
8. Excellent written and verbal communication skills with attention to detail.
9. Creative problem-solving and critical thinking skills.
10. Prior experience in small company environment is a desired.
11. Team player that operates easily in an informal but fast-paced biotech environment.

Overview:

Phenomix has two clinical programs: one is a late stage program in diabetes and the other is an early stage program in hepatitis C. Multiple studies are being conducted worldwide. The contracts involving these two programs exceed $ 10M in 2008 and will further grow in 2009 and beyond. The Clinical Trials Finance Assistant supports all administrative and financial activities related to the clinical trials program. S/he will work closely with the Clinical Development personnel, Accounts Payable, Project Management, and Corporate Legal as well as external Clinical Research Organizations (CROs), to assist with clinical budget negotiations, financial analysis, invoicing and contract management.

Summary of Key Responsibilities:

1. Negotiate, prepare, track and analyze clinical budgets related to study sites as well as related clinical supply and laboratory agreements
2. Report on financial account statements and work with investigator budgets
3. With assistance from Corporate Legal, assist with the negotiation of clinical study site agreements. Finalize agreements and track agreement status to ensure complete execution
4. Determine amounts payable to clinical sites based upon agreed upon site budgets and subject visits; ensure all invoices related to the studies/projects are entered and site payments are being made
5. Prepare reports, graphs and charts forecasting financial and related business conditions to the Clinical Development, Project Management, and Finance Departments as needed
6. Prepares the clinical trial year end budget vs. actual reports; also provides assistance with outside auditors in developing fiscal year end schedules and reports related to cash receipts, indirect cost and research expenditures.

Required Skills, Knowledge, Abilities and Qualifications:

1. Degree in Finance or Accounting (minimum BA).
2. Approximately 1-2 years of relevant industry experience supporting finance preferably with clinical programs
3. Proficient experience in building and using complex spreadsheets (Excel) and graphics programs
4. Strong attention to detail
5. Excellent written and verbal communication skills with attention to detail.
6. Ability to produce and present reports as tables and graphs in order to keep track of financial situation (both past and projections into the future)
7. Creative problem-solving and critical thinking skills.
8. Prior experience in small company environment is desirable
9. Team player that operates easily in an informal but fast-paced biotech environment

Summary of Key Responsibilities:

1. Provides clerical and administrative support related to documentation system requirements both an electronic database (document warehouse) and a paper file room .
2. Audit GXP document files in order to ensure compliance with internal and external quality assurance requirements.
3. Maintains documentation to ensure they are accurate, current and available to the appropriate personnel.
4. Maintains filing of all master documents.
5. Administer document change management and control.
6. Assist in development and revision of standard operating procedures, protocols and reports.

Required Skills, Knowledge, Abilities and Qualifications:

1. Approximately 1 year of relevant industry experience in documentation systems.
2. Proficient Computer skills.
3. Strong organizational skills and an attention to detail.
4. Excellent written and verbal communication skills Creative problem-solving and critical thinking skills.
5. Team player that operates easily in an informal but fast-paced biotech environment.

Overview:

In this position, you will be providing medical leadership for the design and implementation of Phenomix’ Phase 3 clinical program with our DPP4 inhibitor dutogliptin in Type 2 diabetes; this program is conducted jointly with a pharma partner. Responsibilities include all clinical trial related activities and safety oversight. You will be part of a multidisciplinary, dynamic team of professionals working on our diabetes program and you may later expand into other therapeutic areas. In addition to the diabetes program, Phenomix currently has an ongoing clinical program in HCV. The position reports to the VP of Clinical Development.

Summary of Key Responsibilities:

1. Take a leadership role in planning the overall strategy for clinical drug product development.
2. Design, prepare, and initiate Phase 3 clinical study protocols and required documentation in compliance with project plans, US- and ex-US regulations, GCP and good medical practice
3. In conjunction with clinical operations, evaluate and select global and local vendors for clinical trials (CROs, central labs, IVRS, EDC etc.).
4. Participate in the selection of clinical investigators; provide proper investigator profile for study, assist in conducting investigator meetings.
5. In conjunction with clinical operations, oversee day to day operation of ongoing clinical studies. If necessary. visit selected sites to trouble-shoot, train/retrain staff
6. Provide medical supervision and training for project teams, study investigational sites, contract research organizations, for the understanding and delivery of study protocols
7. Provide medical and scientific input to review of clinical data, patient medical safety data and laboratory values; maintain an ongoing assessment of the safety profile, and efficacy data
8. Provide medical surveillance on Serious Adverse Event (SAE) reporting, follow-ups, including after hours coverage of medical emergencies
9. Participate in the planning, writing and review of Clinical Study Reports, regulatory updates and submissions
10. Support regulatory filings including INDs and NDA filings
11. Continuing research of new scientific developments, competitor products and research in the area of anti-infective diseases
12. Support corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees
13. Publish study data and present study data at professional conferences. Serve as the medical contact with academic experts, collaborators and opinion leaders
14. Interacting with project management and clinical operations to provide estimate for operational budgets, and assess laboratory requirements
15. Have an understanding of translational medicine including nonclinical efficacy and safety data, PK/PD relationships, etc.

Required Skills, Knowledge, Abilities and Qualifications:

1. 5 to 8 years MD with at least 3 years residency training in internal medicine
2. Sub-specialty training in metabolic or infectious diseases is a plus;
3. 3 to 5 years of pharmaceutical/biotech industry experience;
4. Track record of successfully planning and executing large scale, international, multi-center clinical studies (including regulatory processes and contract hurdles)
5. Thorough experience of supervising and managing CROs and other vendor relationships is a must.
6. Available for approximately 25% travel (applicable only during peak times).
7. Thorough working knowledge of FDA and ICH/GCP regulatory requirement.
8. Scientific publication record

Overview:

The CMC Project Manager drives the development and execution of cross functional project plans. This individual will play a key role within the CMC department, and will serve as the primary project liaison with external partners.

Summary of Key Responsibilities:

1. Facilitate the definition of development plans across CMC functional areas (chemistry, formulation, analytical, quality) in alignment with the development team (Clinical, Preclinical, Regulatory).
2. Facilitate interactions and relationships with external partner(s) by serving as a primary point of contact, driving joint development planning, coordinating information and document flow and tracking actions and follow up.
3. Drive the planning and tracking of clinical manufacturing timelines, coordinating activities across packaging/labeling, DP manufacture, API manufacture, RSM acquisition.
4. Coordinate CMC team meetings including agendas and minutes; help facilitate and keep meetings on track.
5. Draft detailed Project Plans to facilitate communication and tracking of CMC activities, milestones and timelines.
6. Analyze plans to identify the critical path, proactively identifying potential issues and facilitating development of contingency plans.
7. Responsible for oversight of document management for all reports and data relevant to regulatory filings and diligence.
8. Facilitate preparation of the CMC project related budget, ongoing budget forecast updates and tracking of accruals and expenditures against the budget.

Required Skills, Knowledge, Abilities and Experience:

1. Minimum of B.A. or B.S. degree (preferably in Chemistry or related field); advanced degree preferred.
2. 6 to 8 years pharmaceutical industry experience in pharmaceutical sciences or clinical manufacturing and at least 3 years in project management or team leader role.
3. Must possess an overall knowledge of pharmaceutical development, clinical manufacturing and associated Regulatory, QA, and cGMP requirements.
4. Great communication skills; ability to communicate both technical and strategic topics effectively to cross-functional audiences both in writing and verbally.
5. Must be a self-starter, be able to work with minimal supervision and effectively manage multiple priorities. An ability to drive projects to completion is essential.
6. Advanced skills in MS Powerpoint, MS Project and spreadsheets.
7. Detail oriented.

Summary of Key Responsibilities:

1. Liaising with key customers to outline and forecast anticipated supply needs (i.e. Determine CTM requirements based on review clinical protocols, team member discussions and development of supply and logistics assumptions. Calculation of the appropriate quantities of packaged/labeled CTM, bulk drug product, API and raw material.)
2. Supporting clinical supply production planning and coordinating activities between internal groups to ensure timely availability of supplies.
3. Developing project timelines and ensuring that the tasks are completed in a timely fashion
4. Providing budget estimates and updates for packaging, labeling, and distribution activities
5. Coordinating packaging and distribution activities with both internal groups and vendors
6. Managing internal and external contractor and customer relationships
7. Establishing IVRS specifications for re-supply and inventory management
8. Generating and assure cGMP documentation inventory controls and product reconciliation and disposition
9. Assisting in the investigation of deviations, coordinate resolutions, and recommending corrective action.
10. Providing status updates to team members and management and assuring issue resolution

Required Skills, Knowledge, Abilities and Experience:

1. BA/BS degree, or comparable experience, with 4 or more years of proven experience in clinical supply coordination required
2. Strong communication and team skills, working in a matrixed environment
3. Exceptional planning and organizational skills
4. Broad-based computer knowledge including Excel and MS Project
5. Experience authoring SOPs, technical documents, and deviation reports is preferred