Associate Director Clinical Documents

Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!

Alpine Immune Sciences (AIS) is seeking an Associate Director-Clinical Documents (eTMF) to serve as an operational lead for management and oversight of the trial master file (TMF) system at AIS.  This person works in partnership with the study teams in order to ensure trial documents are complete, high quality, and appropriately filed within the TMF system.

 

Duties and responsibilities:

·         Establish strategy for development and management of paper and electronic Trial Management File (eTMF) system through project management and hands-on participation in the configuration and maintenance of the eTMF for each study.

·         Support authoring of TMF Management Plans and provide TMF Indices; work with study teams to check and verify these plans.

·         Provide guidance on best practices for clinical trial records handling, retrieval, and archival procedures.

·         Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to TMFs.

·         Participate in and oversee the quality control of documents (paper and electronic) submitted to the TMF.

·         Support the coordination of the transfer of study specific TMF from CROs into the AIS TMF, if applicable.

·         Educate and support study teams and designated study team content owners in understanding their TMF-related responsibilities, requirements, and expectations; act as an ad-hoc member of the study team, as necessary.

·         Act as a point person for study team TMF questions and manage close-out of TMF related issues.

·         Provide TMF metrics: timeliness, completeness, and quality of TMF documentation and content, and the risk level of outstanding items as requested.

·         Identify any corrective actions which must be assigned and addressed.

·         Provide document records to users (e.g., internal staff and/or auditors) for review including archived records. 

·         Oversee the provision of the required documents at the time of regulatory authority inspection or internal audits.

·         Respond to TMF and non-TMF internal and external information inquiries related to clinical trial records.

·         Identify opportunities for continuous improvement.

·         Manage in-line QC functions for TMF documentation including site regulatory documentation to evaluate and report whether deliverables are completed per contracted services and are in compliance with all appliable local, federal, and international regulations, guidelines, AIS policies, SOPs, and work instructions.

·         Manage, mentor and train individuals reporting into this position, if applicable.

·         Actively support inspections and audits.

·         Resource planning to support TMF activities.

·         Perform other duties as assigned.

 

Qualifications:

·         Bachelor’s degree preferred, or equivalent knowledge/experience gained through a minimum of 8 years’ experience in the clinical trial setting required.

·         Must have strong knowledge of clinical drug development processes.

·         Understanding of the planning, launching, maintenance, and closure of Phase I-IV clinical trials, including global clinical trials.

·         Experience in successfully working with TMF systems.

·         Demonstrated successful setup and management of TMF systems.

·         Thorough knowledge of CFR, ICH/GCP, and GDPR/data privacy requirements.

·         Self-starter comfortable working in a hybrid work environment with department and cross-functional colleagues based in different geographies.

·         Resourceful with keen critical thinking skills; ability to successfully research a variety of topics, including obtaining input from colleagues to drive solutions.

·         Ability to anticipate issues and outcomes and respond strategically, proposing “outside the box”, goal-oriented solutions to challenges in alignment with project and company objectives and values.

·         Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.

·         Proven leadership and interpersonal skills with the ability to work collaboratively as a member of a cross-functional team; excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.

·         Ability to review and analyze performance metrics through various systems.

·         Proficiency with MS Word, Excel, PowerPoint, SharePoint; Smartsheet experience a plus.

·         Experience giving presentations in both department and multidisciplinary settings.

 

Essential Traits:

·         Leads by example and learns from mistakes.

·         Effectively pivots to meet changing demands in priorities when business needs dictate.

·         Completes tasks on time to meet milestones, comfortable proactively communicating to stakeholders if timelines are at risk.

·         Clearly communicates milestones, risks, mitigations, and essential feedback.

·         Values the input of colleagues.

·         Works efficiently without compromising quality.

·         Continually seeks self and team improvement.

·         Innovates and eliminates redundant, inefficient, and manual processes where feasible.

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At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position has a compensation range of $165,000 - $200,000. In order to be considered for a position, candidates must be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).

Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.

Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.

Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.

Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges.  Join us!

 

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