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Associate Director Gcp Jobs (NOW HIRING)

IQVIA

Associate Director Quality

Durham, NC

The Associate Director Quality - Client Dedicated Process & QD Manager performs various activities ... Preferred Document management experience iGrafx/process design experience GCP audit/inspection ...

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Associate Director Gcp information

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$27K

$141.2K

$310.5K

How much do associate director gcp jobs pay per year?

As of Jun 9, 2026, the average yearly pay for associate director gcp in the United States is $141,209.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,000.00 and $212,500.00 per year, depending on experience, location, and employer.

What are some common challenges faced by an Associate Director GCP, and how can these be addressed?

An Associate Director GCP often encounters challenges related to ensuring compliance with evolving global regulatory standards, managing cross-functional teams, and overseeing multiple clinical trials simultaneously. Navigating differences in international regulations and balancing competing priorities can be demanding. Building strong communication channels, staying updated on regulatory changes, and fostering a culture of quality and collaboration within the team are effective strategies for overcoming these challenges. Proactive planning and ongoing training are also key to maintaining compliance and operational efficiency.

What are the key skills and qualifications needed to thrive as an Associate Director GCP, and why are they important?

To thrive as an Associate Director GCP, you need in-depth knowledge of Good Clinical Practice (GCP) guidelines, clinical trial management, and typically an advanced degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and relevant certifications such as GCP or Project Management Professional (PMP) are highly valuable. Strong leadership, problem-solving, and communication skills set outstanding candidates apart in guiding cross-functional teams and ensuring regulatory compliance. These capabilities are essential for maintaining the integrity of clinical research and ensuring trials meet regulatory and ethical standards.

What is the difference between Associate Director Gcp vs Clinical Project Manager?

AspectAssociate Director GcpClinical Project Manager
CredentialsTypically requires advanced degrees (e.g., MD, PhD, or MSc) and GCP certificationUsually holds a bachelor's or master's degree with GCP certification
Work EnvironmentStrategic oversight, cross-functional leadership, and regulatory complianceOperational management of clinical trials, site coordination, and project execution
Industry UsageUsed in pharmaceutical and biotech companies overseeing GCP compliance at a senior levelCommonly employed in clinical research organizations and pharma for trial management

The Associate Director Gcp focuses on strategic, regulatory, and compliance aspects of clinical trials, often overseeing multiple projects and teams. In contrast, the Clinical Project Manager handles day-to-day trial operations, ensuring projects stay on schedule and within scope. Both roles require GCP knowledge but differ in scope and seniority.

What does an Associate Director GCP do?

An Associate Director GCP (Good Clinical Practice) is responsible for overseeing clinical trials to ensure they comply with regulatory standards and ethical guidelines. This role typically involves managing clinical quality assurance activities, developing and implementing GCP compliance programs, and leading audits or inspections. The Associate Director works closely with clinical teams, regulatory agencies, and external partners to guarantee that all processes align with global GCP standards. They also provide training and guidance to staff to maintain high-quality clinical research practices.
Infographic showing various Associate Director Gcp job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $141,209 per year, or $67.9 per hour.

Associate Director, Biostatistics

Genmab A/S

Princeton, NJ • On-site, Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 28 days ago

Job description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
Role:
The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.
Responsibilities
Compound/Indication Level
  • Act as lead and main point of contact related to Statistics for designated compound/indication
  • Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
  • Engage with regulatory authorities on compound/indication level discussions
  • Acts as a role model
  • Ensures consistency of statistical methods and data handling across trials
  • Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
  • Supports compound responsible programmer in developing an integrated database specification

CDT member:
  • Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
  • Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
  • Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
  • Drive design and synopsis development together with relevant stakeholders
  • Ensure transparent communication to relevant stakeholders from the CDT
  • Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
  • Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles

Trial Level
  • Represent Genmab during meetings/congresses and courses and perform professional networking
  • Engage with regulatory authorities on trial level discussions
  • Arranges/attends lessons learned to share learnings
  • Represents Genmab during Key Opinion Leaders meetings
  • Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
  • Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
  • Ensures state of the art statistical work which includes but is not limited to:
  • Applying adequate methods for which a solid scientific foundation exists
  • Ensure proper documentation of work done
  • Keep oversight and QC essential documents/data provided by vendors
  • Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP

CTT member:
  • Participate and represent Biostatistics
  • Review and provide input to protocol and amendment development
  • Perform vendor oversight according to applicable SOPs
  • Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.
  • Review assay validation reports, as applicable
  • Perform exploratory analysis, ad hoc analyses, and modelling of data
  • Review and approve randomization and stratification plans
  • Perform UAT of Randomization part of the IRT system as applicable
  • Ensure procedures for blinding are in place as applicable
  • Support timely delivery of statistical deliverables
  • Responsible for planning and conducting trial result meetings
  • Review and approve the CSR
  • Attend trial and investigator meetings if/as needed
  • Collaboration with Genmab Global Drug Safety:
  • Participate in definition, review, and approval of data packages for Data Monitoring Committees
  • Review and approve any amendments, corrections, and updates of data packages
  • Support regulatory submission/filing activities

Experience:
  • Master's or PhD in a statistical discipline
  • 8+ years of experience in relevant area preferred, or demonstrated capability
  • Experience in statistical analysis, modelling and simulation and adaptive trial designs
  • Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
  • Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
  • Experience with the relevant regulatory requirements for biostatistics processes and SOPs
  • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
  • Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
  • Experience directing multiple complex projects/studies in a technical capacity
  • Proven performance in earlier role/comparable role

For US based candidates, the proposed salary band for this position is as follows:
$156,880.00---$235,320.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
  • 401(k) Plan: 100% match on the first 6% of contributions
  • Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
  • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
  • Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
  • Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
  • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

About You
  • You are genuinely passionate about our purpose
  • You bring precision and excellence to all that you do
  • You believe in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
  • You take pride in enabling the best work of others on the team
  • You can grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so!

Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

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