Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description:

The Director of Clinical Operations is responsible for the overall operation of complex clinical studies including project planning, budget, resource management, contract research organization, and vendor management and oversight. The Director, Clinical Operations may oversee single complex studies, or provide oversight of a program of studies, managing the clinical operational plan and incorporating the study and scientific plan.

The ideal candidate will be responsible for creating study-related documents or reviewing those prepared by other clinical trial managers to ensure protocol adherence. They must ensure compliance with Good Clinical Practices (GCP) and regulatory guidelines. This role involves recommending and implementing innovative process improvements to enhance clinical trial management and offering strategic input to the Program Team on the execution of the Clinical Development Plan. The candidate will manage clinical budgets, develop contingency plans for clinical trials, and oversee clinical trial staff to ensure the successful delivery of all studies within their program. Additionally, they will act as a cross-functional liaison to align operational plans with business development strategies. Responsibilities may also include selecting, developing, and evaluating personnel to ensure the function’s efficiency, and they may serve as a line manager for other Clinical Operations staff.

Experience:

• BA/BS degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities
• 12+ years of global clinical pharmaceutical industry experience including at least 8 years demonstrated skills and competency in clinical project management tasks and the management of staff
• Demonstrated ability to inspire effective teamwork and motivate personnel within a direct line management and matrix system
• Experience in managing global drug development programs
• Proven ability to negotiate with stakeholders and vendors in a professional manner
• Available for domestic and international travel, including overnight stays

Responsibilities:

• Line management responsibility for the recruitment, training, development, and performance review of personnel
• Oversee the development, implementation and adherence to project plans and relevant performance indicators
• Oversee financial performance, including ongoing assessment of financial progress of all assigned projects
• Assist project team members in reviewing scope, contracts, financial and operational performance of vendors
• Track study budgets closely, with a focus on burn rate, scope changes and timely discussions with finance relating to any required changes to budgets
• Oversee the selection of vendors and act as vendor point of escalation and be actively involved in vendor governance
• Establish and maintain appropriate levels of vendor governance, including actively participating in vendor governance meetings
• Identify resource needs for new projects
• Develop and maintain connections and good working relationships with vendors, key opinion leaders, principal investigators, and internal stakeholders
• Facilitate the resolution of any issues arising from project team/vendor relationships
• Facilitate collaboration between internal departments
• Input as required into development of essential study documents including protocols, ICFs, study plans
• Undertake process improvement initiatives in clinical operations
• Mentor and coach clinical operations team members and support growth and development of the clinical operations team in collaboration with SD Clinical Operations, Clinical Supply and Data Management
• Collaborate with Wave colleagues in patient recruitment and retention initiatives
• Plan and participate in study specific site related meetings (SIVs, co-monitoring visits), Investigator Meetings, Other site engagement activities as required
• Attend relevant scientific and patient advocacy conferences as required
• Support regulatory inspections including preparing clinical operations pre, during and post inspection to ensure minimal findings
• Support regulatory interactions as clinical operations representative as required
• Manage and be accountable for clinical operations SOPs, WI, policies and guidance documents
• Ensure GCP compliance of clinical operations team
• Perform other appropriate duties as assigned by management.

Key Skills:

• Demonstrated excellent leadership skills
• Proven financial analytical skills
• Sound planning and organizational skills
• Demonstrated problem solving and decision-making skills
• Displays effective communication skills and can communicate in the English language (oral and written)
• Proven interpersonal skills
• Understanding of clinical research principles and process
• Able to delegate effectively and prioritize own and workload of project team members
• Cross cultural awareness and ability to adapt appropriately.
• Strong negotiation skills
• Experienced in the creation and implementation of new processes
• Good computer skills

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.