AbbVie

Head of Asset in GU, Oncology Clinical Development

AbbVie • $150K — $200K *
Waltham, MA 02453In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Medical Doctor (M.D.) or equivalent with relevant therapeutic specialty required, preferably with residency and fellowship training.
  • At least 7 years of clinical trial experience; 9+ years preferred.
  • Demonstrated ability to independently manage complex clinical research programs.
  • Strong leadership skills with experience in influencing cross-functional global teams.
  • Commitment to mentoring junior staff, encouraging autonomy and development.
  • Extensive knowledge of clinical trial methodology and regulatory requirements.
  • Excellent communication skills in English, both written and verbal.
  • Ability to tackle complex problems and devise solutions across multiple projects.

Responsibilities

  • Manage and guide Medical and/or Scientific Directors in clinical trial execution and research planning.
  • Lead design and implementation of clinical development programs adhering to regulatory standards.
  • Oversee clinical study teams, ensuring data integrity and meeting regulatory guidelines.
  • Serve as lead for the design, analysis, and scientific reporting of clinical documents.
  • Chair Clinical Strategy Teams to align development plans across functions with contingency considerations.
  • Act as an in-house expert, coordinating scientific activities related to therapeutic projects.
  • Engage with opinion leaders and collaborate with various functions to shape Clinical Development Plans.
  • Stay updated on industry trends through professional development and represent the organization at key external events.

Benefits

  • Comprehensive medical/dental/vision insurance options.
  • 401(k) plan for retirement savings with company contributions.
  • Paid time off including vacation, holidays, and sick leave.
  • Long-term incentive program participation for eligible employees.
Full Job Description
Job Description

Manages other Medical and/or Scientific Directors and leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
  • Personally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel.
  • Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols assigned.
  • Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
  • Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
  • May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
  • Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.


Qualifications
  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
  • At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
  • Ability to run a complex clinical research program independently.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
  • Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
  • Ability to interact externally and internally to support a global scientific and business strategy.
  • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
  • Must possess excellent oral and written English communication skills
  • Ability to exercise judgment and address complex problems and create solutions across multiple projects.


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 thisposting 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 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 anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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