Director, Clinical Operations

Location
Beltsville, MD
Posted
Oct 06, 2020
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Description
NextCure is a start-up biopharmaceutical company located in Beltsville, MD, and focuses on the discovery and development of novel immunomedicines for the treatment of cancer and other diseases. We are seeking a highly motivated Director of Clinical Operations to provide input on the overall operational plans across all programs and manage CROs and external vendors to ensure timelines and budgets align within programs. The candidate must thrive and adapt to a fast-paced, innovative and changing environment. 

Responsibilities
•    Function as the primary liaison for internal stakeholders and vendors, as appropriate
•    Lead accountable to deliver trial(s) on time, within budget, and with highest achievable quality
•    Assists in the review, development and/or writing of clinical trial documents and manuals, required to execute the trial(s)
•    Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
•    Generate reports to update management on conduct of trial(s)
•    Ensure appropriate clinical trial supply plans are implemented and managed
•    Review/develop recruitment plans, risk-mitigation plan, monitor and implement contingencies as required
•    Assist with third party vendor training on protocols and practices
•    Lead the multi-disciplinary trials teams; include the study team meetings, external meeting and Sr. Management review.
•    Function as the primary contact for trial(s) between other departments;
•    Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
•    Drafting of clinical scientific documents such as IND, IND amendments
•    Investigator Brochures, Annual Reports and other FDA submissions
•    Monitor, review and summarize safety and efficacy data in ongoing studies
•    Develop relationships with appropriate consultants
•    Write/edit abstracts and present data at scientific meetings, both internally and externally
•    Serve as liaison to project teams, CRO's and others 
•    Engage in special, value added projects
•    Manage third party vendors and resources
•    Provide general operational support, including business analysis

Required education and experience
•    Degree in nursing or scientific/life-sciences field. Pharm.D. or Ph.D. preferred
•    Minimum of 8 years of experience in clinical operations within the biopharmaceutical industry 
•    Prior Oncology Drug Development experience a plus

Qualifications
•    Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
•    Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
•    Multi-task and manage shifting responsibilities
•    Working knowledge of drug development
•    Strong attention to detail
•    Works well with diverse functional teams to coordinate activities and achieve project goals
•    Strong analytical, problem solving, critical thinking, organizational and planning skills
•    Demonstrated leadership capability
•    Excellent communication, negotiation and interpersonal skills
•    Organized, results-oriented, proactive strategic thinker
•    Possess excellent team building, training and facilitation skills
•    Mediator of solutions while building alignment among key stakeholders
•    Ability to think on feet
•    Seeing the big picture and acting in anticipation of future needs or necessary adjustments for achieving desired objectives
•    Outstanding project management and organizational skills and ability to multitask and perform in a fast-paced entrepreneurial and growing environment
•    Solid interpersonal skills and ability to work in matrix team environment
•    Demonstrated understanding of the biotech/pharma industry and therapeutic product development
•    Passionate about scientific innovation, self-starter, goal-driven, and strive to continuously build knowledge and skills for personal, professional and organizational growth
•    Excellent written and oral communication skills
•    Strong Analytical ability
•    Oral and Written proficiency in English

NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged team work environment.