Director Clinical Operations

3 days ago

Gaithersburg, United States Actalent Full time
Our team is looking for a Director, Clinical Operations to oversee and manage the clinical programs and teams in Gaithersburg, MD (hybrid 2X per week). Our client is a clinical-stage biotech dedicated to advancing therapies aimed at treating multi-drug resistant infections. Our mission is to tackle today's most challenging infections and those on the horizon. We are seeking driven and insightful individuals to join us in pursuing these goals.
Summary: The Director of Clinical Operations will play a pivotal role in guiding the design and implementation of clinical trials. This position entails overseeing several outsourced clinical research programs with a focus on combating bacterial infections, particularly those caused by multi-drug resistant pathogens. The Director of Clinical Operations will be responsible for the successful execution of various clinical programs. They will ensure that these clinical trials are conducted efficiently within established timelines and budgets, while upholding the highest standards of quality in accordance with Good Clinical Practice international standards.
  • This role demands active leadership in all operational facets of clinical testing for groundbreaking biopharmaceutical drugs at a company deeply committed to enhancing patient outcomes. The incumbent will provide strategic leadership and operational guidance for all regulated clinical programs aimed at securing global marketing approval. This position requires a hands-on approach, with the opportunity to make a tangible impact on the lives of patients.
  • Support the planning and implementation of clinical training, ensuring ongoing oversight and continuous training throughout active clinical trials. Coordinate and manage all clinical operational activities across assignments.
  • Lead and manage clinical operations staff, including external consultants and outsourced clinical research organization personnel responsible for clinical monitoring and data management of clinical trials. Ensure the delivery of high-quality operational results while maintaining consistency in processes and approaches.
  • Assist in overseeing, drafting, and reviewing regulatory documents for submission to regulatory authorities, such as NDAs, INDs, annual reports, and responses to inquiries from regulatory authorities and institutional review boards/ethics committees.
  • Define and oversee clinical trial plans across a range of infectious disease target areas.
  • Manage Contract Research Organizations (CROs) effectively to ensure that clinical studies are conducted to the highest quality standards, delivered on time, and within budget. Take responsibility for clinical project timelines and budgets. Facilitate the completion of study-specific procedures and plans generated by CROs, partners
  • Collaborate effectively with cross-functional teams to ensure the timely delivery of clinical trial materials to clinical sites and contribute to the development of procedures for managing clinical samples for laboratory testing.
  • Demonstrate a strong understanding of FDA and other regulatory authority requirements that impact clinical studies.
  • Develop internal systems to ensure that clinical studies are conducted in compliance with current regulations and to prepare the company adequately for audits and inspections by government sponsors, FDA, and international regulatory authorities.
  • Oversee the selection process for CROs, clinical trial sites, potential investigators, and external contractors. Monitor and evaluate clinical site performance as necessary.
  • Oversee and contribute to the development of department Standard Operating Procedures (SOPs) to ensure that company policies and procedures align with current international regulations and guidelines.
Qualifications:
  • 10+ years of clinical operations experience within study management
  • Experience managing clinical operations teams
  • Complex therapeutic area experience (rare disease, infectious disease, auto-immune disease, etc.)
  • Double Blinded Placebo Study Experience highly preferred
  • Bachelors Degree minimum
  • ***MUST HAVE EXPERIENCE COMING FROM SMALL OR MID-SIZE PHARMA/BIOTECH***
Logistics:
  • HYBIRD (2-3X per week onsite)
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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