As defined in the scope of the assigned development project(s), the Assistant Medical Director, Clinical Development – Monitoring, will have global responsibilities and fulfill the following roles:
The Medical Monitor Clinical Development (MD) may 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 where needed.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all AbbVie policies and procedures.
Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.
The Assistant Director Medical Monitor (MM) is responsible and accountable for the medical and safety data evaluation and case assessment of clinical trials. The MM supports the clinical studies in the Pipeline Commercialization Model, including Development studies and Life-cycle management. The MM fosters an atmosphere of collaboration, mutual respect, transparent communication, and data driven analyses according to the highest scientific standards and a focus on efficient and timely solutions. He/she/they lead/s the responses for medical data questions, in collaboration with the TA-SD and/or TA MD and other applicable functional ex. statistics, regulatory, data management and regional input. The MM is responsible for:
- Data Review not otherwise reviewed by DSS in Clinical Trials.
- Handling action items and medical communications and document safety assessments within IT systems.
- Working wiex.th the Therapeutic Area Scientific Director (TA-SD) and/or Therapeutic Area Medical Director (TA-MD) to resolve any study-level issues and lead on any medical decision-making.
- Responding to medical safety related protocol questions.
- Reviewing/approving/signing off protocol related safety documents.
- Reviewing/approving/signing off safety coding.
- Reviewing/approving/signing off safety sections of the CSR.
- Reviewing/approving/signing off safety narratives.
- Establishing lab alert/panic values where appropriate.
- Overseeing ECG data where applicable.
- Following escalated safety data through resolution.
- Participating in a DMC when established for clinical trials.
- Providing contact information for clinical trial protocols.
- Being the point of contact for medical emergency inquiries for clinical trials, answering phone inquiries from clinical trial sites and maintaining accurate phone information, a voice mailbox, and will check voice messages at least once daily.
- Completing review of safety data findings with the Safety Reviewer, and documenting outcome of the review.
- Escalating relevant safety data review findings to the Product Safety Team.
- Staying abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
- Ensuring adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Supporting the clinical trial throughout development, and lifecycle at internal or external meetings (e.g., with Regulatory Authorities, with external experts)
- Medical degree (e.g., MD, DO, MBBS); scientific knowledge and experience in the relevant Therapeutic Area preferred.
- Minimum 7 years of overall work experience or equivalent combination of experience and education, preference for 3 years of clinical/research experience in the pharmaceutical/device industry.
- Preferred at least 1 year of experience in medical monitoring of clinical trials, though not required.
- Track record of successful management of product safety matters (labeling negotiation, etc.) preferred.
- Experience in preparation of risk management plans, aggregate reports and company core safety information highly desirable.
- Sound judgment and experience in medical interpretation of safety findings for clinical trials.
- Working knowledge of MedDRA and drug coding dictionaries (e.g. WHODRUG).
- Knowledge of basic statistics and Pharmacoepidemiology.
- Ability to work cross functionally with different disciplines and across geographies.
- Travel up to 10% of time, including international travel
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.