Associate Director, Clinical Program Management

About Codera 

Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. 

Position Summary

The Associate Director, Clinical Program Management (CPM) is responsible for leading assigned clinical studies to support Aurinia’s clinical development programs. CPM is accountable for the operational delivery of assigned Aurinia clinical studies from concept through reporting, including inspection readiness, regulatory submission(s) and regulatory review(s). The CPM is an expert on the operational delivery of clinical trials and will bring that expertise to the design and conduct of clinical studies. The CPM is accountable for proactive operational risk management for Aurinia’s clinical studies and will collaborate with all Aurinia functional areas to deliver high-quality clinical trials in accordance with planned milestones.

Essential Duties and Responsibilities

Support CPM Leads with operational tasks and overall conduct of clinical studies

Manage study operational plan, including project timelines, budget, and quality of deliverables, throughout the duration of the assigned clinical studies

Partner closely with Aurinia functional areas to ensure delivery of all study and site goals (e.g., start-up, enrollment, data flow, quality, etc.)

Monitor study progress against plan; develop and implement operational risk management plans

Participate in the selection of study vendors

Responsible for vendor set up from selection through study close-out

Management of site and vendor-related issues to resolution

Responsible for vendor engagement and oversight, maintaining frequent contact and oversight of applicable vendors to assess performance and provide guidance as needed

Participate in the selection of investigational sites

Oversee protocol deviation and risk management reviews

Manage study-specific team training per study plans and procedures

Provide input in the development of department processes, procedures, and guidelines, as required

May provide or facilitate training of clinical study teams on assigned protocol specific topics

Liaise with all internal and external team members and stakeholders to facilitate achievement of study goals

Contribute to the creation and finalization of relevant study documentation by providing operational input into protocol design, clinical study reports as well as other operational plans (monitoring plan, data management plan, etc.)

Work proactively to ensure alignment on data flow and timely delivery of data; may participate in study data review and other review activities as necessary

Provide ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting and planning

Ensure the submission of trial-related and essential documents to the Trial Master File (TMF)

Support submission activities, as necessary

Develop and provide key input to the Clinical Trial Budget (e.g., per subject costing)

Review and approve informed consent form (ICF) and study/country/site level ICFs as appropriate

Support with alliance management, as needed

Serve as a resource to facilitate audit/inspections, as applicable

Qualifications

Bachelor’s degree in nursing, Life Science or related field required; Advanced degree preferred

Minimum 4-5 years of clinical trial conduct experience with at least 3-4 years of experience at a CRO or biopharmaceutical organization required

Prior Clinical Research Associate (CRA) experience preferred

Detailed understanding of all aspects of clinical protocol design and implementation as well as understanding of overall drug development required

Thorough understanding of FDA, ICH and GCP guidelines

Previous experience negotiating vendor/site contracts and managing budgets preferred

Must be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skills

Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines

Ability to establish collaborative working relationships with internal and external stakeholders

Proven leadership abilities in a highly complex and dynamic environment

Ability to inspire a collaborative team environment

Ability to work in a dynamic environment with a high degree of flexibility

Ability to interpret study level metrics data and identify risks

Ability to proactively identify and mitigate risks through study lifecycle

Proven experience leading meetings and discussions with internal and external stakeholders

Attendance at all Investigator Meetings, Aurinia all company meetings, as well as occasional travel to sites

Must be willing and able to travel domestically up to and/or internationally up to 15%

The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice. 

The estimated annual base salary for this position is $160,000 - $230,000, commensurate with experience and skills. 

Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs.

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 

Codera participate in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.