Clinical Program Manager
Location: South San Francisco, California, United States
The Clinical Program Manager (CPM) has accountability and responsibility for the successful operational execution for all assigned studies in accordance with the overall study and program-level plans. The CPM provides leadership, strategic planning and operational delivery of assigned clinical studies across all phases of study management (i.e., preparation, study start-up, conduct, close-out and reporting), in accordance with Assembly Biosciences quality standards, all applicable regulations, timelines and budget commitments.
Key Responsibilities include:
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required and in coordination with SMT Study Leader.
- Coaches and provides support to responsible study team members
- Provides oversight, leadership and support to Contract Research Organization (CRO) and other vendors (IWRS, central laboratory) to ensure overall delivery
- Oversees study feasibility, site monitoring performance, and ensures eTMF completeness and oversight of all relevant compliance activities
- Collaborates in quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions (CAPA) for allocated studies in China.
- Provides oversight of the TMF and ensures the TMF is inspection ready
- Develops and maintains optimal working relationships with investigator sites, vendors, and key opinion leaders
- Reviews and contributes to the development of clinical operational documents including ICF, protocol, study plans, timelines.
- Performs data cleaning activities and reviews study data remotely in EDC and identifies trends and escalates to the SMT as needed.
- Contributes to Clinical Operations SOP, Work Instructions, tools and templates, and Best Practices development by providing local clinical operations expertise.
- Contributes to initiatives within Clinical Operations/Clinical Development as part of process improvement efforts.
Preferred Qualifications include:
- Bachelor’s degree with 10+ years of clinical research experience in the pharmaceutical / biotechnology industry including study management of clinical trials Phase I-III. Hands-on experience with viral hepatitis, and/or clinical operations in Asia will be considered in lieu of years of actual experience.
- Experience developing study execution strategies, risk mitigation, and successful site/country selection
- Thorough knowledge ICH/GCP guidelines
- Demonstrated proficiency in the implementation, monitoring and management of clinical trials and broad cross-functional knowledge and understanding of clinical trial methodology
- Ability to interpret study level data & translate and identify risks
- Global study management experience in China, India or other countries with high prevalence of HBV and experience in study management of virology trials is desirable
- Fluency in English in both written and oral communication skills. Fluency in Mandarin in both written and oral communication skills is desirable but not required
- Line management experience including performance review and career development for direct reports
- Solid vendor management skills
- Solutions-oriented, innovative, analytical, and well organized to drive clinical studies to successful completion
- Willing to embrace change and work in a dynamic environment
- Able to work collaboratively across cultures and geographies
- Strong communication skills to ensure that clinical study plans are transparent, and risks, issues and results are clear to all SMT stakeholders
- Motivated self-starter with the proven leadership potential and the ability to understand, plan, and navigate in a matrixed environment. Successful candidates should possess the drive to work independently with minimal supervision in a fast-paced environment
- Strong interpersonal and communication skills including exceptional collaboration and relationship management skills
- Organized and detail-oriented with the ability to balance attention to detail and the “big picture”
- Proficiency in Microsoft Word, Project, PowerPoint, Excel, SharePoint
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
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.
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