Associate Director, Study Manager (Immunology)

Job Description

This position participates in the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross-functional team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.

Job Responsibilities

• Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s).

• Serves as the Clinical Trial Team lead.

• Leads and directs teams in key study planning, development, and execution elements (e.g. operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance).

• Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.

• Liaises with partners, vendors, and vendor management team.

• Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate.

• May serve as a subject matter expert and/or participate on process improvement teams.

• Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.

• May include management of direct/ indirect reports including assignment of resources, professional development, and performance management

Core Skills

Demonstrated ability to drive and manage scientific activities on clinical

protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:  

• Strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)

• Proven ability to manage competing priorities and effectively delegate and assign activities to meet the business needs

• Ability to develop short and mid-range project plans that are realistic and effective at meeting goals.

• Strong analytical skills to drive operational milestones

• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division

• Interact with key stakeholders across department, division, and company. Roles requires a proactive approach, strategic thinking and leadership driving toward study goals.

• Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment.

• Problem solving, prioritization, conflict resolution, and critical thinking skills

• Strong communication, writing, and presentation skills

• Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Education/Experience

• Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience

• OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience

• OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience

• Degree in life sciences, preferred.

• Experience in planning and executing clinical studies in ophthalmology highly preferred

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 

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