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Clinical Operations Program Lead

MedImmune, LLC

Gaithersburg - Corporate Headquarters, MD
Posted Date:
Position Type:
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description


With minimal guidance and oversight from the Therapeutic Area Director (TAD), the focus of the Global Clinical Operational Strategy organization is to provide the operational input and design into the integrated Product Development Plan (iPDP) process in a way that involves all key stake-holders so that the Clinical Development Plan (CDP) produces efficient and effective projects. This position is a Product Development Team (PDT) representative who serves a critical role that demands strong collaboration and teamwork that transforms a CDP into clinical operational deliverables. These milestones must satisfy all internal and external customers by using strong analytical approach to make decisions that remain congruent to the iPDP strategy. Capable leadership will ensure that the team maintains momentum by focusing on pre-determined objectives that satisfy expectations for costs, timeframe and resourcing. This position requires versatility to be an effective facilitator at various levels in the organization to solve problems by addressing root cause issues. The person must be respected by the teams so that they are free to challenge decisions in a way that leads to better decisions while maintaining the team commitment.

This position is a Clinical Sub Team (CST) and PDT member position, and may be aligned to one or more drug projects dependant on size and scale of the project. This function leads the operational planning and oversees delivery of clinical studies from integrated Product Development Plan (iPDP) inclusive of the Protocol Concept Sheet (PCS) to final Clinical Study Report (CSR) to agreed budget, time and quality. The focus is across the program level collaborating with the Product Development Team (PDT)/Global Product Team (GPT), Clinical Operations Organization as well as other functions that are key to the clinical development of a compound to facilitate good decision-making throughout the development life cycle.


The Clinical Operations Program Lead will act independently and function as the Product Development Team representative for Clinical Operations; they will supervise the Clinical Operations Project Manager or Managers that act as the leads for their assigned studies and will have significant interactions with colleagues at the Clinical Sub-team level. Manages the Clinical Operations remit within the PDT and/or GPT structure. The COH provides direction and counsel for clarity on portfolio prioritization, management and overall communication escalation issues.

Job Complexity:

Highly complex function that manages multiple internal and external stakeholders including Key Opinion Leaders (KoLs) and vendors to ensure the overall deliverables according to agreed timelines, budgets and quality. They must be able to influence those at higher levels, as well as, those that indirectly report to them to focus on pre-determined objectives. The position requires regular contact with persons of influence and decision-making authority within the MedImmune Medical Organization and overall R&D as well as other global and regional functions. This necessitates considerable tact, discretion and persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships



Major Responsibilities:

* Minimum of twelve years of experience in the pharmaceutical industry.
* Minimum of six of those years must have been working in an environment of clinical study delivery/clinical project management.
* Extensive and proven experience in driving operational delivery to timelines, cost and quality.
* Proven experience of leading delivery through collaboration with internal organization and external providers.
* Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery.
* Proven ability in proactive problem solving and risk management that is solution focused.
* Proven Global Project Management experience with expertise in program level resource and budget management.
* Preferred program level experience across the product life cycle and across multiple therapeutic areas, with experience in global drug development.
* Experience and strength in working and leading in matrix teams.
* Strategic Skills including a high level of creativity, innovation, and problem solving with an ability to manage effectively through ambiguity are required.
* Strong collaborative communications ability to engage with a diverse client base inclusive of high level conflict management capabilities are required.
* Ability to motivate team members and build cross functional teams in support of the PDT/GPT vision is also required.
* Must provide strong leadership and facilitation skills to link strategic direction to a clear operation plan.
* Ability to motivate team members and build cross functional teams in support of the PDT/GPT vision.
* Can provide strong leadership and facilitation skills to link strategic direction to a clear operation plan.
* Must be willing to travel both domestically and internationally.


* Bachelors of Science or Bachelor of Arts degree in related discipline, preferably in medical or biological science, or equivalent work experience in directly related fields of endeavors.
* Advanced degree is preferred.
* Certification or Degree in Project Management is a plus.

MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.

My company shares my passion for helping to improve human health around the world.

This is My MedImmune

Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.

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