- Build and lead the Clinical Solutions & Compliance team to create, deploy and manage Clinical Operations' systems, process and procedures, training programs, GCP compliance and regulatory inspection activities.
- Oversee the development and deployment of Clinical Operations' Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP regulations and company policies to ensure inspection readiness.
- Drive the implementation of a proactive, risk-based approach to Quality into Clinical Operations systems and processes by integrating principles of Risk Management per ICH E6/E8.
- Support the design and implementation of Clinical Operations' Sponsor Oversight framework, ensuring high-risk outsourced activities are meeting 4DMT performance standards.
- Ensure optimal relationships with key internal stakeholders, as well as vendors, to enable the successful development and deployment of Clinical Operations and cross-functional Development processes, clinical systems, quality documentation and training programs, as appropriate.
- Partner with Clinical Quality Assurance to oversee Inspection Preparation initiatives and support GCP regulatory authority inspections.
- Provide oversight and strategic guidance for key clinical systems, such as eTMF, CTMS and IWRS, ensuring systems development strategies protect the integrity of GCP records and data.
- Actively participate as a member of the Clinical Operations Leadership Team in the development of organizational goals and strategies.
- Lead key strategic Clinical Operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments. Includes the identification of process challenges, process enhancement, and training of teams.
- Accountable for the line management of Clinical Solutions & Compliance staff, including development, coaching, talent planning and performance management.
- Provide input to and rationale for department budget and maintain control of functional expenditures against department budget.
- Develop and present strategic and operational plans to senior management.
- Ideal candidate will have demonstrated ability in the following areas: GCP regulatory authority inspections, process development & improvement, training & development, development of a clinical compliance function, and clinical systems
- Experience developing and leading a clinical risk management function/process and the ability to demonstrate an understanding of a clinical quality management system
- Previous experience in managing a group or business unit, including the management of budgets, timelines and resources
- Strong working knowledge and interpretation of FDA/EU and ICH - GCP regulations and guidelines
- Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
- Strong strategic planning and decision-making skills
- Proven ability to convey clear direction and accountabilities to team and delegate work that empowers ownership
- Deals comfortably with uncertainty of change and effectively handles risks with ability to be flexible and adaptable to changing business needs
- Must have the ability to build and maintain positive relationships with senior management, peers, and direct reports
- Focused on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors
- Willingness to work in a dynamic and changing corporate environment
- Previous experience leading key strategic functional initiatives
- Excellent written and verbal skills required. Must display strong analytical and problem solving skills
- Willing to travel domestically and internationally, as needed
- Excellent communication and interpersonal skills
- Must be able to write clearly and summarize information effectively
- Must be able to present complex information to various audiences
- Bachelor degree or equivalent required
- 15+ years of experience of applicable industry experience in drug development across both early (Phase 1 or 2) and late-stage (Phase 3) clinical development
- minimum of 6+ years managerial experience
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sr director, clinical solutions - Emeryville, CA, United States - BioSpace
Description
Job DetailsAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL SUMMARY:
The Senior Director of Clinical Solutions & Compliance is accountable for defining the vision, mission and strategy for the function, which resides in the Clinical Operations organization. This position has responsibility for overseeing clinical systems, training programs and implementing appropriate processes and procedures to ensure GCP compliance and inspection readiness within Clinical Operations. The Sr. Director will also sponsor and/or lead key strategic Clinical Operations organizational initiatives. This position will also be responsible for people/team management and mentoring of indirect and direct reports.
Essential Duties & Responsibilities:
Responsibilities:
$234,000/yr - $295,000/yr
National Range:
$212,000/yr - $268,000/yr
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
