Medical Director, 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.
In AbbVie Oncology Early Development (OED), we strive to develop a rich and innovative pipeline of transformative cancer therapies by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners – scientists, clinical experts, industry peers, and patients – to discover and develop medicines that drive groundbreaking improvements in cancer treatment.
We are growing our clinical development team and are seeking a Medical Director to be based in our Redwood City site. In this position you will be responsible for:
- The design and implementation of one or more clinical development programs in support of an overall Product Development Plan and leading project-related education of investigators, study site personnel, and AbbVie study staff.
- Oversight of clinical studies, monitoring study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, overseeing study enrollment and timelines for key deliverables. Performing assessment and reporting of serious adverse events per corporate policy and regulations.
- Designing, analyzing, interpreting, and reporting scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- Providing in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal partners. Potentially participating in due diligence or other business development activity. Contributing in partnership with Discovery colleagues to design and implementation of translational strategies.
- Possibly serving on or chairing a Clinical Strategy Team (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 Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB).
- Acting as a clinical interface and actively soliciting opinion leader interactions related to the molecule and disease area; partnering 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.
- Keeping abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
- Understanding the regulatory requirements related to the clinical studies and global drug development and accountable for following those requirements. Serving as a clinical representative for key regulatory discussions.
- Ensuring adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- 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. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- Associate Medical Director: Minimum 1-3 years of industrial experience
- Medical Director: 3+ years of industry experience. Preferred 5 years Oncology experience in Biotech/Pharma industry.
- 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 through influence.
- 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 build solutions for one or more projects.
Significant Work Activities
Yes, 20 % of the Time
Job Level Code
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.