Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.
Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.
About the Role:
The Executive Director, Clinical Operations will be a key leader with responsibility for strategic oversight and operational leadership for the global management of Insmed’s clinical trial portfolio reporting to the Vice President of Clinical Operations & Medical Writing. The incumbent will work closely with multiple functions across the company to ensure all operational trial deliverables are completed according to timelines, budgets, operational procedures, quality standards and SOPs. Key responsibilities will include coordinating and leading the global clinical trial management, study planning, financial oversight, vendor management, trial timeline management, and ensuring ICH/GCP compliance. The Executive Director, Clinical Operations will provide expertise/strategic guidance to staff within the organization and will work closely and collaboratively with other senior and functional leaders to ensure fully harmonized and integrated development strategies and to drive portfolio prioritization. The incumbent will maintain a blend of strategic and operational accountabilities while working with collaborators in advancing and expanding the company. He/she will be accountable for successful execution of clinical studies and programs to meet pertinent timelines, clinical milestones and corporate objectives.
Additional representative responsibilities will include, but not necessarily be limited to, the following:
Direct Report/Performance Standard/Timeline Oversight:
He/she will oversee the management, professional development, training and performance of the US Clinical Operations trial staff (Directors, Trial Managers, CRAs). Leads initiatives to build and advance the clinical department staff infrastructure through resourcing plans. In alignment with broader company goals, establishes staff performance goals and monitors achievement of those goals. Establishes, monitors and reports on performance standards and metrics for the execution of all clinical trials and related activities with a focus on proactive identification of issues and implementation of appropriate mitigation strategies and corrective actions. Implements best practices and standards for trial management in collaboration with other members of the clinical operations team, including input to the establishment of SOPs. Collaborates with CQA to ensure that clinical trials meet regulatory requirements and are inspection ready. Accountable for the delivery of Insmed’s Clinical Trial portfolio measured against Global Project Team timelines and Corporate Objectives.
Third Party Vendor Oversight:
Identify, evaluate, select, manage and provide oversight of CROs and other third-party vendors; ensures senior CRO management is appropriately involved with key studies. He/she will review master service agreements, statements of work, and quality agreements relating to clinical projects.
Identify and implement innovative solutions to resolve roadblocks in patient recruitment and clinical trial execution via development of an overall outsourcing strategy including CRO management. Utilize robust and creative approaches to maximize the value of CRO activities with a rigorous approach on budgetary control. Evaluates the balance between outsourcing and in-house approaches for the various clinical development needs. Lead strategic CRO partnership oversight and governance.
Owns the clinical operations budget and provides accrual, forecasts and monitoring of budgets, headcount, and resources across all clinical programs for near term and long-range planning; develops accurate assumptions and prudent allocation of resources.
- Minimum of a Bachelor’s Degree in life sciences or business operations is required
- Minimum of 20+ years of pharmaceutical or biotechnology industry experience, 15 years of clinical study management experience in increasingly responsible leadership roles, and minimum of 10 years managing direct reports
- Strong experience in vendor management, leading CROs/various contracted resources, site monitoring and clinical quality compliance, and managing clinical trial budgets and clinical finance activities
- Demonstrated expertise in global clinical operations development and strategic planning; experienced with early to late stage clinical trials, and with the IND to NDA process
- Prefer working experience in rare/orphan disease
- Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices
- Well-honed leadership skills: takes personal responsibility for outcomes, thrives on increasing levels of responsibility, confidently moves the business forward, uses insightful thinking to effect organizational change and drive innovation, harnesses organizational skills and sense of urgency to motivate self and team to meet pressing deadlines in fast-paced environment, uses strong line management skills (ability to attract, hire, retain, mentor and develop staff)
- Strong team player: displays positive attitude and rolls up sleeves to contribute to team efforts, builds strong relationships with a wide range of stakeholders at all levels (e.g., Senior Executive Team, KOLs, regulatory bodies, peers on cross-functional and cross-regional teams, etc.)
- Detail and quality oriented with a demonstrated track record of driving projects/deliverables to completion within established deadlines, budget and allocated resources
- Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills
- Requires ability to make high level strategic and tactical decisions within global and distributed team environments
- Strong verbal communication and scientific writing skills, and good interpersonal/group skills
- Must demonstrate tact and the ability to positively influence others and provide feedback to subordinates in a multi-cultural environment and across all organizational levels
- Roll-up-your-sleeves orientation and a strong ability to work in a team-based environment
- Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
- Up to 30% travel
- Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
- Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
- Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.