Medical Director, Hematology Clinical Development

AbbVie; New Jersey; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in New Jersey is seeking a physician with oncology/hematology expertise to lead clinical development programs across multiple studies. You will ensure study integrity, monitor safety and efficacy data, and drive regulatory submissions in alignment with the Development Plan.

The role requires 2+ years of trial experience, strong English communication, and ability to lead cross-functional teams across global sites. AbbVie offers comprehensive benefits and long-term incentive programs.

Qualifications

• MD or equivalent with Oncology/Hematology specialty.
• At least 2 years of clinical trial experience in pharma, academia, or equivalent.
• Ability to run a clinical research program of moderate complexity.
• Ability to interact across a global cross-functional team.
• Knowledge of clinical trial methodology, regulatory and compliance requirements.
• Excellent oral and written English communication skills.

Responsibilities

• Oversee one or more clinical development programs within a Development Plan.
• Monitor study integrity and safety/efficacy data across trials.
• Design, analysis and reporting of clinical study documentation.
• Oversee work of junior medical/scientific staff as needed.
• Collaborate with Discovery and other functions to translate translational strategies.
• Engage with key external stakeholders and advisory interactions as required.

Skills

English communication

Cross-functional collab

Regulatory knowledge

Education

MD or equivalent (Oncology/Hematology)

Oncology residency (preferred)

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube.

Purpose:

Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities:

• Manages the design and implementation of one or more clinical development programs in support of an overall 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 and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
• Has overall responsibility for oversight of clinical studies, 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 oversight of 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 on which assigned.
• Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
• May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in 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.
• May serve on or chair a Clinical Sub-team, or it's equivalent with responsibility for development of a rigorous, cross-functionally-aligned, vetted Development Plan with full consideration of contingencies and alternative approaches. In the role as lead of the Clinical Sub-team (or it's equivalent), responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Strategy Team (AST), AST Leadership Board (ALB) and/or other cross-functional teams and internal stakeholders.
• Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; 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.
• 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.

• Medical Doctor (M.D.) or non-US equivalent of M.D. degree with relevant therapeutic specialty (Oncology, Hematology) Completion of a residency program in Oncology strongly preferred.
• At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a clinical research program of moderate complexity with minimal supervision.
• Ability to perform and bring out the best in others on a cross-functional global team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• 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

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole and absolute discretion unless anduntil paid andmay bemodifiedat the Company's sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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