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Assoc Dir Med Study Ops
4 months ago
The Associate Director, Medical Operations will oversee the various activities and programs within Medical Study Operations, including Investigator-Initiated Studies Programs for various respiratory indications, Collaboration Studies, and Compassionate Use Programs led by Medical Affairs, may include management of direct reports, maintaining appropriate structure and procedures to support growth, and ensuring compliance. Additionally, the incumbent will support MA projects, as requested.
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Support of Commercialized Products in a Global Setting
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Provide Operational oversight for an expanding program outside the US.
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Budget Tracking, Planning, Reporting: Oversee all budgeting aspects in support of multiple programs or product. Oversees budget reporting cross-functionally and externally as appropriate.
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Oversee program management activities across multiple programs or product, including: vendor and CRO support, budgets, timelines, drug costs/quantity, and adherence to appropriate workflows. Ensuring optimal internal/external alignment for multiple programs or product
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Systems Management: Ensure utilization of appropriate systems to optimize cross-functional communication, planning and transparency.
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Process Management & Review: Ensure adherence to all relevant processes, trainings, and SOPS. Continued process improvements to ensure consistency, efficiency, and compliance.
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Driving Organizational Goals: Development of objectives in order to quantify success and attainment of goals. Ensures optimal structure, procedures, and adequate resources supporting growth of multiple programs or product. Knows when to escalate issues, and involve senior levels of management to obtain adequate resolution.
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Alliance Management: Ensuring optimal alignment with both Alliance and internal stakeholders in support of multiple programs or product. Responsible for driving activities forward while communicating potential risks and solutions transparently.
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People Management (if applicable): Management of direct reports, trainings as deemed necessary, workload distribution for optimal effectiveness, performance against defined goals and expectations, and support for individual growth. Uses discretion when determining: who (if anyone) to assign specific team deliverables to. Guidance is typically needed by direct reports for success.
JOB REQUIREMENTS:
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14+ years of "progressive" industry/relevant professional experience. Biotech/Pharmaceutical experience mandatory
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9+ years active work experience in area of clinical research and/or regulatory and//or field-based function in pharmaceutical and/or biotech company(ies) and experience or courses pertaining to clinical research and/or MA functional area
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Incumbent must have a track record of being
successful in fast-paced, dynamic environment, self-motivated, works with limited supervision, once acclimated to role and enjoys working with different stakeholders Incumbent must have track record of working well in a dynamic environment, must be self-motivated, able to work with a limited amount of supervision after the initial on-boarding period and enjoy working with different stakeholders (clinical, pre-clinical, commercial, external customers).
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
