Associate Director, Clinical Data Management
Position Title: Senior Manager/Associate Director, Clinical Data Management
Reports to: CMO
Status: Regular, Full-time, Exempt
Location: San Francisco, CA
Assembly Biosciences (NASDAQ symbol ASMB) is a clinical-stage biotechnology company advancing two innovative platform programs: a Hepatitis B-Cure program consisting of a new class of oral therapeutic candidates for the treatment of hepatitis B virus (HBV) infection and a novel class of oral synthetic live biotherapeutic candidates, which are designed to treat disorders associated with the Microbiome.
The HBV pipeline consists of a lead program in multiple global Phase 2a studies; a 2nd Generation program entering Phase I late this year, and a 3rd program approaching clinical candidate selection. We expect this pipeline to represent a backbone therapy for increasing cures in HBV, and can be envisioned as a foundation of the company’s research in virology globally.
The Microbiome platform consists of our lead programs in GI, partnered with Allergan, nearing the first IND/Phase Ib later this year and early next for Ulcerative Colitis, and a pipeline of other disease areas in consideration for advancement that are wholly owned by ASMB.
The Company has a strong balance sheet having recently raised $166 million, bringing its cash reserves to approximately $250 million – and thus positioned well to build the next phase of Assembly toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
The Senior Manager/Associate Director, Clinical Data Management provides direction, oversight and coordination of all data management (DM) activities according to quality standards, regulatory requirements, and project budget from study start-up through archival in support of Assembly Biosciences, Inc (ASMB) development programs.
This position will have strategic responsibility for oversight of Contract Research Organizations (CROs) performing Data Management activities for ASMB studies. This position will have strategic responsibility for staffing and operational aspects of the data management group, and participate in defining a vision for the department which can be integrated into the overall corporate vision. The candidate is expected to develop, articulate, and implement strategies to actualize DM goals.
Specific responsibilities include, but are not limited to:
- Provides Clinical Data Management (DM) oversight and strategies to colleagues and direct reports to ensure CROs and vendors are performing in compliance.
- Provides Clinical Data Management oversight and strategies for selection of CROs for data management activities
- Reports CRO and vendor compliance to ASMB, as well as expectations, target dates and contract requirements, to ASMB Management.
- Contributes to development of outsourcing strategies and relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
- Evaluates Data Management partners and provides study teams with recommendations on selecting DM partners starting from RFP through the contract finalization and subsequently through contract modifications (if applicable) to ensure DM tasks performed with acceptable quality, on time and on budget.
- Provides oversight on quality database validation and deployment for all databases for SI sponsored studies, both internal and externally held databases.
- Ensure consistent processes across all studies for multiple projects and across all CROs and vendors.
- Provides coaching and mentoring and performance management for DM to enable successful oversight of CROs and vendors.
- Establishes goals, expectations and accountabilities for staff, regularly reviewing DM performance with respect to quality and timeliness standards.
- Contributes to the development and delivery of department goals in support of corporate goals.
- Plans, allocates and prioritizes resources.
- Reviews and approves group deliverables.
- Contributes to development of DM budgets.
- Directs teams and ensures all databases are developed, validated and ready for transfer and / or analysis according to policies and procedures, SOP's and work instructions (either by ASMB or CRO) in compliance with applicable regulations.
- Works in collaboration with QA and other functional groups, develops and updates data management standard processes and procedures in accordance with CFR, GCP, ICH Guidelines and GCOMP minimum standards and best practices.
- Provides technical direction to facilitate the adoption and use of technologies for DM and trial management, especially in relation to efficient technologies and processes to work with CROs.
- May supervise direct reports and contractors.
- Approximate travel <10%.
- Bachelor’s Degree in a relatable field; Master’s Degree is preferred.
- Minimum of 10 years of experience in Data Management in pharmaceutical R&D required, including oversight of studies supported by CROs, data import, data cleaning, and custom report generation. OR - Minimum of 10 years at a CRO working in data management, supporting industry sponsored trials.
- Knowledge of all applicable regulations including; CPR, GCP, and ICH Guidelines.
- Minimum of five years of supervisory/management experience.
- Ability to work and collaborate in a global DM organization.
- Experience with Regulatory Inspection activities.
- Ability to promote and maintain a positive and professional attitude.
- Ability to motivate and lead a team of varying levels of status & ability.
- Ability to lead global process improvement efforts, including interactions with CROs.
- Attentive to details and able to independently resolve a variety of issues without close supervision.
- Proven Organization & Planning skills.
- IT literate and knowledge of Database Review and/or Management Systems (e.g., J-Review, RAVE, Medrio, Clinplus, Omnicomm, MERGE, SAS, Oracle, Clintrials, Oracle Clinical, eDM, etc. – knowledge of all is not necessary).
- Proficient with the application of EDC, IVR, ePRO, and other remote data capture systems in the industry.
- Excellent communication skills - verbal, written & interpersonal.
- Working knowledge of medical terminology and experience with clinical research desired.
- Working knowledge of ICH/GCP and of regulatory obligations of the pharmaceutical industry is essential.
- Ability to articulate clearly and conduct verbal presentations with large and small audiences.
- Willingness to travel via automobile and airplane.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.