Medical Director, Hematology Clinical Development

AbbVie; Waltham (MA); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a physician leader to oversee the direction and execution of clinical development programs. You will guide studies across the translational to lifecycle phases, ensuring data quality and regulatory alignment.

The role demands strong collaboration with Medical Affairs, Clinical Operations and external investigators, plus robust English communication and leadership across global teams.

Qualifications

• Must hold an MD with oncology/hematology specialty.
• Minimum 2 years of clinical trial experience in pharma, academia or equivalent.
• Ability to run a clinical research program of moderate complexity.
• Ability to interact cross-functionally to support a global strategy.
• Knowledge of regulatory requirements governing clinical trials.

Responsibilities

• Oversee design and implementation of one or more clinical development programs within the overall Development Plan.
• Monitor study integrity and interpret accumulating safety and efficacy data.
• Develop, analyze and report scientific content for protocols and regulatory submissions.
• Provide clinical expertise and coordinate activities with internal stakeholders and external investigators.
• Supervise matrix team members and participate in cross-functional committees as needed.

Skills

Cross-functional collaboration

Clinical research leadership

Excellent English communication

Education

Medical Doctor (M.D.) or non-US equivalent

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, X and YouTube.

Company 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, X and YouTube.

Job Description

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.

Qualifications

• 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

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.

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