Sr. Director, Clinical Operations

1 Days Old

is looking for a director-level subject matter expert to build and lead a clinical operations team focused on advancing our clinical programs while upholding our core values and staying true to our mission. Reporting to the Head of Clinical Operations, the Sr. Director, Clinical Operations will play a key role in the operational planning, oversight, and delivery for one or more clinical programs.
Position Responsibilities: Develop and implement clinical project plans in accordance with corporate objectives Evaluate outsourcing partnerships and define go-forward strategy for identifying, engaging and managing long term strategic partnerships Provide oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical trials. Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.) Proactively develop and implement hiring plans to attract, recruit, on-board and retain best in class talent to effectively execute against program milestones Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of the trial Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget Identify, evaluate, and recruit clinical trial sites Contribute to global clinical / regulatory submissions As a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiency Undertake line management responsibilities for assigned team members, serving as coach and mentor Contribute to the development of departmental SOPs and work instructions May require travel, including international travel Candidate Requirements:
Bachelor's Degree (scientific discipline preferred); advanced degree preferred Minimum 12 years of experience in a biotech/pharmaceutical/ CRO setting; minimum 10 years of clinical operations experience; minimum 5 years in a supervisory role Proven record of success running complex drug development trials Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development Highly organized, outcome oriented, self-motivated performance Comfortable in a fast-paced environment with the ability to adapt to change In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice Outstanding oral and written communication skills including experience authoring clinical protocols and other key trial documents
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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Location:
Danvers, MA, United States
Category:
Management Occupations

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