Join Our Team
Working for our company presents the opportunity to work in unique, dynamic roles in the field of biotechnology. You will be immersed in cutting-edge biotech research. Business is expected to grow exponentially over the next several years. Our technologies and products help thousands of patients every year, and we strive to make a profound difference on a global stage with our scientific advancements.
Director of Clinical Operations – Signature Biologics
The Director of Clinical Operations is responsible for providing clinical insight, advocate for the team members, and must possess knowledge of acute surgical procedures and hospital related practices to ensure prompt patient recruitment, clinical trial site selection, clinical trial execution and optimization with a focus on both speed and quality. He/she will provide leadership skills, proactively identify potential program challenges, come up with solution(s), and be a strong advocate for the trial manager(s)/ trial associates.
- Executes clinical studies to establish the safety, efficacy and commercial viability of new products.
- Participates in the formulation of overall clinical development strategy.
- Experience in conduction pediatric and adult hospital based clinical research trials.
- Manage Phase 1-4 clinical research and operations including strategic direction, clinical trial protocol design and initiation of clinical trials to optimize tactical and clinical value through US and Global Clinical Trial Site Selection and data portability.
- Actively participates as the lead research team member interacting with and providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures.
- Manages study timelines, deadlines and budgets to include negotiating contracts with study vendors, CROs and clinical trial sites/PI’s.
- Works with clinical research/operations team and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs.
- Is responsible for site initiation, site oversight and monitoring, on-site presentations, site close-out, understanding adverse events, leads and coordinates a multidisciplinary team.
- Communicates and interacts frequently and effectively with in-house personnel, clinical sites and outside contractors/CROs.
- Participates in investigator meetings.
- Develop, revise, review and implement SOPs for Phase 1-3 Clinical trials and trial related activities.
- Ensure compliance with all applicable regulatory standards related to US and global clinical trials and interactions with physicians including but not limited to Sunshine Act.
- Develop and maintain professional relationships with academic and community-based physicians, clinicians and principal investigators to assure good clinical input to product development process, marketing and sales teams
- Interface with departments within and outside of including Regulatory Affairs, Compliance, Marketing, Medical Affairs and Sales Teams.
Skills and Experience
- Minimum 10 years of experience in pharmaceutical / medical device industry with at least 5 years of hands-on managerial experience running clinical trials and managing teams.
- Minimum 5 years experience managing clinical trials.
- Minimum 5 years experience working in the CRO matrix environment managing global development program as a Lead Clinical Research Associate (CRA)/ Clinical Trial Lead (CTL) or Clinical Program Lead (CPL) preferred.
- Demonstrated detailed knowledge of medical/surgical procedures, and hospital/acute care medical practices (pain management standards and guidelines preferable but not essential).
- Demonstrated solid working knowledge of cGCP, ICH and other relevant clinical development regulations and processes to include appropriate FDA regulations including NDA, 505(b)(1), 505(b)(2), 510 (k) regulatory pathways, pediatric research guidelines, European, APAC, LATAM and global Regulatory Authority Submissions etc..
- Excellent written and oral English communication and presentation skills with excellent professional demeanor and presence,
- Demonstrated commitment to working within Regulatory and Compliance constructs.
- Strong MS Office Skills including production of GANTT charts/timelines etc.
- Proven knowledge of and experience in Phase 1-4 clinical trial design and protocol development.
- Demonstrated understanding of statistics and statistical methods
- Excellent analytical and organization skills; able to set priorities and meet deadlines.
- Ability to work effectively on a team in an entrepreneurial environment.
- Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions/resolutions to problems.
- Extraordinary research skills, exposure to conducting hospital based research trials and expertise in searching medical literature and databases for clinical, medical and technical information.
- Proven ability to forge cross-functional working relationships with internal teams. Clinical Trial Sites/PI’s, external contractors, vendors, and customers.
- Demonstrated ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the clinical trial and resolve the issues in a timely fashion.
- Ability to travel up to 25% with short notice when necessary.
- Ability to comply with all medically required hospital/clinical site immunization requirements.
- Valid driver’s license in the state in which you reside.
- Masters degree in a health, biological sciences or research related field from accredited college or university preferred.
To apply, please email a cover letter and resume to email@example.com
Associate | Customer Service – Signature Biologics
Company is looking for a Customer Service Associate to join the team, who will be an essential part of the company to support our company’s operations in order to commercialize our placental derived tissue products in the United States. Reports to the Sr. Director of Sales.
Essential Functions of the Associate
- Fully responsible to provide excellent customer service to internal and external customers about the status of fulfillment via phone, e-mail and Salesforce.com Service Cloud platforms
- Follows diligent process to create, package and ship orders accurately to customers
- Inspects incoming orders and new customer requests for completeness and accuracy
- Ensure customer invoices and shipping documentation is correct on all orders
- Works with quality and other departments to capture Work Instructions and/or Standard Operating Procedures for existing procedures in a timely manner for systems and routine audits
- Manages all Customer Service requests into Salesforce.com Service Cloud Case Management by directing data creation, follow ups and customer contact into a single system to create a single point of audit
- Works with management to routinely use Case Management data to provide Voice-of-Customer reporting
- Takes on Tier 1 and Tier 2 technical support requests, builds personal and companywide repository of answers to FAQs from customers – retains records to drive single response solutions to customers
- Establishes with management of public Key Performance Indicators (KPIs) across their internal functions
- Captures, details and proposes new ideas on improving key customer service procedures/metrics to management for consideration and works to implement them with approvals
- Abides by and ensures fulfillment center activities comply with all company, OSSHA & posted safety standards
Essential Skills of the Associate
- Enjoys detailed processes and the satisfaction of high-performance metrics
- Effective written, oral and electronic communication skills
- Proven ability to work within shipping, accounting and ERP systems
- Ability to lift and/or move heavy loads (packages up to 50 lbs)
- Ability to stand/walk for 4-6 hours per day
- Efficient at using MS Office, VOIP & E-mail
- Direct experience handling international and domestic shipping customs a plus
- Experience with Salesforce.com or other Customer Service Collaboration platforms a plus
- Direct experience with freight brokers and negotiating contracts a plus
- Direct experience managing others or a sincere desire to manage others a plus
- High School Diploma or equivalent (Associate Degree or Higher a Plus)
- Full Time Position working at the Corporate Fulfillment Office located in Farmers Branch, TX
- Monday through Friday from 8am to 5pm with some OT based on shipping schedules