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Associate Director, Clinical Development

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on XFacebookInstagramYouTubeLinkedIn and Tik Tok.

Job Description

The Associate Director, Clinical Development will have global or regional responsibilities. Lead the design, development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Provides medical and/or scientific direction to project/study teams. Should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.

The position may be based in Branchburg, NJ or Irvine, CA.

Responsibilities:

The Associate Director will be responsible and accountable for the development, implementation, and delivery of the global clinical development strategy for a given project within time, budget and with high quality.  This will entail leading the development of the Clinical Development Plan in collaboration with the Clinical Team and ensuring alignment with the agreed Global Development Strategy/ Integrated Evidence Plan.  

Responsibilities include the following:

  • Assists in the design of clinical studies. Responsibilities may extend from early translational development activities to mature product life cycle strategies.
  • In conjunction with Clinical Leader, designs, conducts, reports clinical trials in line with the development, regulatory and commercial strategy.
  • May be responsible for opinion leader development within the therapeutic area Interacts with and coordinates appropriate scientific activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going clinical studies or projects.
  • Assists as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
  • Assists in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences or medical literature and acts as a therapeutic area resource.
  • Represents AbbVie at external meetings including investigator meetings, scientific association meetings, partner discussions, etc. 
  • Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements
  • May lead cross functional sub-teams responsible for defined sub-projects within the therapeutic area (individual publications or study collaborations).
  • May initiate research projects compatible with project plan goals and drive them to completion, resulting in high quality publications
  • Responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, and publications associated with the clinical trials.
  • You will participate in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, in collaboration with clinical operations, is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan and is responsible for acting as a key contact for the Integrated Evidence Strategy Team, and Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project.
  • Providing scientific/clinical oversight for the clinical trial in collaboration with the Clinical Sub-team members.
  • Ensuring the review of clinical data, including protocol deviations.
  • Interpreting and communicating, with the CPL, clinical trial results.
  • Collaborating with the clinical leaders, and functional representatives in the development of clinical trial, regulatory and other scientific documents (e.g., Regulatory documents, presentations at congresses and publications).
     

Qualifications

  • Relevant science degree (e.g., Masters, MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Toxins) preferred.
  • Minimum 7 years of overall work experience or equivalent combination of experience and education.
  • Minimum 5 years of clinical/research experience in the pharmaceutical/device industry preferred.
  • Ability to travel up to at least 15% of time, including international travel.
     

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our short-term incentive programs. ​

  • This job is eligible to participate in our long-term incentive programs​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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Average salary estimate

$140000 / YEARLY (est.)
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$120000K
$160000K

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What You Should Know About Associate Director, Clinical Development, AbbVie

Are you ready to make a significant impact in the world of medicine? AbbVie is looking for an Associate Director of Clinical Development to join our team in Branchburg, NJ. In this exciting role, you’ll lead the design, development, and execution of clinical studies that tackle some of the most serious health issues today. AbbVie, known for its commitment to innovative solutions in therapeutic areas like immunology and oncology, offers a vibrant environment where your expertise can shine. You will take charge of creating comprehensive clinical development strategies, working closely with cross-functional teams to ensure alignment with global objectives. You'll also mentor junior team members, guiding them in their professional growth while enhancing internal processes. Collaboration is key! Expect to engage with stakeholders across the organization and even represent AbbVie at external scientific meetings. With at least 7 years of experience in the life sciences and a strong background in clinical development, you’ll play an integral role in shaping our clinical processes. If you are passionate about leading projects that matter and making a difference in patients' lives, AbbVie is the place for you!

Frequently Asked Questions (FAQs) for Associate Director, Clinical Development Role at AbbVie
What are the primary responsibilities of the Associate Director, Clinical Development at AbbVie?

The Associate Director, Clinical Development at AbbVie holds a critical role involving the design, development, and execution of clinical studies. This includes leading the creation of the Clinical Development Plan, collaborating with teams to achieve strategic goals, ensuring scientific integrity, and mentoring junior staff.

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What qualifications are required for the Associate Director, Clinical Development position at AbbVie?

Candidates for the Associate Director, Clinical Development role at AbbVie should possess relevant degrees such as an MD, PharmD, or PhD, alongside a minimum of 7 years of overall experience in the life sciences. Ideally, applicants would also have 5 years of clinical experience within the pharmaceutical industry.

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How does the Associate Director, Clinical Development contribute to AbbVie's mission?

The Associate Director, Clinical Development plays a vital role in AbbVie’s mission by developing and executing clinical trials that lead to innovative treatments. Their work directly contributes to understanding and addressing serious health challenges, aligning with the company's goal to improve patient lives.

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What opportunities for advancement exist for the Associate Director, Clinical Development at AbbVie?

At AbbVie, the Associate Director, Clinical Development can explore numerous opportunities for advancement through leadership roles, participation in high-impact projects, and mentoring relationships, fostering both personal and professional growth within the company.

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What kind of team collaboration can the Associate Director, Clinical Development expect at AbbVie?

The Associate Director, Clinical Development will engage in extensive collaboration across various functions, including commercial, clinical operations, and regulatory teams. This cross-functional teamwork is essential for planning and executing clinical studies effectively.

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Common Interview Questions for Associate Director, Clinical Development
Can you describe your experience with clinical study design?

In your response, highlight specific projects where you’ve led study designs, detailing the methodologies you applied and how you ensured data integrity. Discuss your collaboration with cross-functional teams to emphasize teamwork.

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How do you approach mentoring junior team members?

Explain your mentoring philosophy, providing examples of how you’ve supported junior colleagues in their growth. Share how mentoring contributes to team success and knowledge sharing.

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What strategies do you use to keep abreast of regulatory requirements?

Discuss how you stay updated on regulatory guidelines through continuous education, attending conferences, and networking with regulatory professionals. Share an instance where this knowledge influenced a project.

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Discuss a challenging clinical trial you managed and the outcome.

Describe the challenges encountered and the steps you took to address them. Emphasize the skills you utilized in problem-solving and how the experience reinforced your clinical management skills.

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How do you ensure scientific integrity in clinical studies?

Detail your methods for maintaining scientific integrity, such as establishing data monitoring practices, ethical oversight, and engaging with advisory boards. Provide specific examples to illustrate your commitment.

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What role does cross-functional collaboration play in your current work?

Share examples of successful projects that benefited from cross-functional collaboration. Discuss how communication strategies facilitate teamwork in achieving clinical development goals.

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How do you handle conflicts within a project team?

Discuss your approach to conflict resolution, including active listening and mediation techniques. Provide an example demonstrating your ability to maintain a positive team dynamic.

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What is your experience with interpreting clinical trial data?

Highlight your experience with data analysis, focusing on specific trials where your interpretations led to actionable insights. Discuss the impact these findings had on project direction.

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Can you explain how you develop and implement a Clinical Development Plan?

Discuss the steps you take in developing a Clinical Development Plan, including stakeholder engagement and alignment with global strategies. Highlight your successes in implementing and executing such plans.

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Why do you want to work at AbbVie as an Associate Director, Clinical Development?

Express your alignment with AbbVie’s mission and values. Discuss your passion for innovative medicine and how your expertise can contribute to the company’s success in addressing health challenges.

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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: i...

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January 10, 2025

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