Medical Director, Tumor Dependencies, Oncology Early Development
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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie has a proven track record in hematologic malignancies, including several approved indications for Imbruvica and Venclexta. Building the oncology portfolio through the strategic development of a broad pipeline is a key focus for AbbVie. The tumor dependencies group in early oncology seeks to build upon our current presence in hematologic malignancies and help define the next generation of therapeutic advances to solidify our presence in hematologic cancers and build a presence in solid tumors. We are developing the next advances as they relate to apoptosis, cell signaling, and other key pathways with regard to how they inter-relate to support cancer cell survival.
The Medical Director role is a key strategic position, partnering early with discovery teams to understand the science and the disease and define the initial clinical strategy for phase 1 development. The Medical Director is an important leader and partner in the cross-functional team who builds strong relationships linked to common purpose to execute the strategy in partnership with project leadership, clinical operations, regulatory sciences, statistics, data management, and others.
- Leads and demonstrates ownership of the design and implementation of multiple clinical development programs 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, and AbbVie study staff.
- Has overall responsibility for leading 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 on which assigned.
- 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.
- May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
- Lead Clinical Strategy Teams (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Lead, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
- Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical 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 clinical translational strategies.
- Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Oncology Development, Regulatory, 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 Oncology Early 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.
- Medical Doctor (M.D.) or non-US equivalent of M.D. degree. Completion of a residency program and subspecialty fellowship in medical oncology is preferred. Additional practice experience in oncology and running or designing clinical trials is highly desirable. Strong background in hematologic malignancies and understanding of key unmet needs in the hematologic space also desirable.
- Associate/Director/Senior Medical Director title: Commensurate on totality of experience and talent of the individual candidate.
- Strong scientific curiosity and passion to partner cross-functionally to find answers and strategies to solve key oncologic problems.
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to run complex clinical research programs independently, addressing complex problems and creating solutions through exercise of sound judgement.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
- 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 the development of clinical strategy and the design of study protocols.
- Must possess excellent oral and written English communication skills.
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Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.