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Associate Director, Clinical Operations & International Studies Management- Remote Opportunity

 
Requisition ID:  1653
Location: 

Deerfield, Illinois, US

Date:  Feb 18, 2021
 

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

 

This is a remote position:  Open to candidates anywhere in greater United States

 

SUMMARY: 
Responsible for the strategic design and management of projects and assists with the development, direction, and execution of clinical programs for all Lundbeck products. Manages the execution of complex multicenter, multinational phase 1-4 studies and supports certain aspects of a group of clinical studies. Responsible for the project timelines, resources, and for developing the budget and overall forecast for clinical studies. Leads study specific global project teams and external partnerships.
 
ESSENTIAL FUNCTIONS:
 
•    Performs, with minimal supervision, the facilitation, development and implementation of clinical trials to meet or exceed development plan timelines, and to remain on budget.
•    Assists with study planning, including synopsis development, and development of timelines, budgets and risk management plans. 
•    Manage global studies ensuring adherence to country specific regulations and guidelines.
•    Leads a cross functional Study Team including CRO/vendor staff and manages the operational tasks relating to the planning, execution and ongoing reporting of clinical studies.
•    Ensures study team activities are completed to timelines and according to the quality standards defined by regulations, relevant privacy laws, Lundbeck Code of Conduct, Lundbeck SOPs and ICH GCP. Ensure appropriate involvement and communication with relevant stakeholders are represented in the study team, Outsourcing Management, CROs as well as line managers.
•    Prepares, participates and assists as necessary in audits/inspections by ensuring study essential documents are appropriately filed at site and in the Sponsor TMF and respond to audit/inspection reports.
•    Ensures that quality data are produced to meet the agreed timelines of study; and compliance with serious adverse event (SAE) reporting procedures and timeframes is achieved.  
•    Mentor and provide training as delegated on study procedures. 
•    Serves as main point of contact for sites and CROs/vendors, enabling day-to-day contact to proactively resolve any issues as they arise in a timely manner. Creates specifications, recommendation, work order negotiation, payment structure and milestones for clinical contracts with CROs.
•    Effectively communicates (oral and/or written) project-related information including the planning and execution of meetings and presentations and work with Clinical Operations and other functional areas. 
•    Assists in periodic reviews of SOPs relative to clinical operations. May be called upon to author SOPs.
•    Delegates tasks to necessary personnel as needed to achieve on-time, on-budget, and on-spec study results and manages resources effectively and creatively to achieve business needs.
•    Seeks to optimize operational models and provide input to process improvements; including SOP revisions.
•    Lead/participate in cross functional working groups/projects.
•    May participate in global or local projects as assigned.
•    May be responsible for direct reports.
 
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
•    Accredited Bachelor's Degree
•    10+ years’ experience in roles of increasing responsibility in clinical departments conducting clinical studies; including project management experience, in a pharmaceutical, biotech, or CRO setting
•    Prior experience in planning & executing pharma-sponsored phase 1 through phase 3 clinical research studies (both domestic and international) intended for use in global regulatory submissions
•    Experience conducting complex study protocols in patients
•    Strong scientific background with knowledge of the drug development process.  Versed in GCP, ICH and CFR regulations.
•    Excellent written and oral communication and presentation skills.
•    Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
•    Ability to manage multiple priorities, while maintaining attention to detail.
 
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
•    Accredited Bachelor's Degree preferably in Life Science.
•    Accredited Advanced Degree (e.g., MS, Ph.D. or Pharm D) preferably in Life Science.
•    Prior experience with timeline and budget development for clinical study programs including outsourced work.
•    Experience preparing and conducting a variety of presentation types including management and project team updates and investigator meetings.
•    Experience conducting CNS studies.
•    Significant experience working within CRO outsourced model.
•    Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels.
•    Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and EDC platforms).
 
TRAVEL
Willingness/Ability to travel up to 40% domestically. International travel may be required.

 

The range displayed is specifically for those potential hires who will work or reside in the state of Colorado, if selected for this role, and may vary based on various factors such as the candidate's qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $140,000 - $175,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site.

 

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

 

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

 

 

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
 
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
 
Read more at www.lundbeck.com/global/about-us/progress-in-mind
 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.