Passage Bio Overview: Passage Bio is an exciting, fast-paced, rapidly growing gene therapy company headquartered in Philadelphia, PA. Our portfolio of rare monogenic CNS gene therapies is the result of an exclusive collaboration with the renowned Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) that provided Passage Bio with 17 gene therapy candidates developed in the lab of gene therapy pioneer Dr. James Wilson. Passage Bio is on a mission to provide life-transforming gene therapies for patients with rare monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.

 

Job Overview:        

We are seeking a responsible, organized, and highly motivated individual as the Director of Clinical Operations. This position provides the opportunity to work in our large-scale and fast-paced practice.

The Director of Clinical Operations should be well qualified and have at least five years’ experience working in a Healthcare setting, to oversee all clinical operation activities, including oversight and direction of CRO and clinical site activities, and will ensure that clinical trials are up and running on time, recruiting to expectations, and delivered in accordance with regulatory standards and within budget.  This position will report to the VP of Clinical Development.

Responsibilities:

·        Responsible for administrating, directing, training, planning and coordinating all clinical trial operation activities.

·        Designs, develops, and implements processes, procedures and policies that increase yield and/or improve quality for patient satisfaction.

·        Develop guidelines for prioritizing work flow evaluating effectiveness and modifying activities as necessary.

·        Manage daily operations at all clinic sites and coordinates the work activities and schedules for clinical trials.

·        Coordinates with CROs, clinical site staff, and office leaders to ensure excellent customer service and resolves all site concerns/complaints.

·        Develops, implements, and maintains processes, procedures, and programs to improve the safety, and productivity of the clinical operation.

·        Coordinates with clinic staff to implement and maintain OSHA and company programs and standards.

·        Provides leadership, communication, and coaching to employees; cultivates a motivated employee environment of trust, teamwork, accountability, self-confidence, and business ownership.

·        Prepares all required reports and correspondence with CRO and clinical trial sites and coordinates with CRO and clinical trial sites to maintain overall clinical operations budget.

·        Coordinates with management to develop, implement, and monitor department budget and expenses within approved budget constraints. Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.

·        Performs other duties as assigned by supervisor.

 

Requirements:

·        Bachelor’s degree (B.A/B.S.) in related field or equivalent preferred.

·        Five to ten years related experience or equivalent.

·        Demonstrated proficiency in supervising and motivating subordinates

·        Excellent written and oral communication skills

·        Strong organizational, problem-solving, and analytical skills

·        Ability to manage priorities and workflow

·        Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

·        Ability to work independently and as a member of various teams and committees

·        Proficient on excel, word, power point and practice management software, PM.

·        Proven leadership and business acumen skills

·        Proven ability to handle multiple projects and meet deadlines

·        Strong interpersonal skills.

·        Ability to deal effectively with a diversity of individuals at all organizational levels.

·        Good judgement with the ability to make timely and sound decisions

·        Ability to understand any and all safety requirements.

·        Ability to effectively communicate with people at all levels and from various backgrounds