Group Medical Director, Oncology Early Development Calico
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.
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology early development pipeline through internal research teams and external partnerships. More than 1,000 AbbVie scientists, clinicians, and product developers with innovative roots work across these sites. They combine their expertise in small molecules, immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is located at the AbbVie South San Francisco/Redwood City, CA location, but remote location will be acceptable for a truly exceptional candidate.
The OED Group Medical Director for our Calico Collaboration will be central to AbbVie and Calico’s oncology pipeline programs. Leveraging patient care and oncology clinical trial experience, this leader will guide strategic planning and decision making across multiple functions, bringing together scientific, clinical, data, and regulatory experts to develop next generation therapies for cancer patients. Under the direction of the VP, AbbVie Oncology Early Development, this leader will partner with AbbVie R&D leaders across Discovery and Development as well as with AbbVie Head of Calico and our partner to make timely, effective decisions for the oncology pipeline.
- Provide strategic oversight for all Calico OED Programs: partner with AbbVie/Calico project leaders to ensure effective collaboration throughout early development stage. Make recommendations to Senior Leaders in ABV and Calico on Program outcomes and next steps, championing ongoing investment in the programs that will serve unmet patient needs.
- Drive transparent, clear communication on oncology program status, performance, and outcomes in a complex, multi-functional and mulit-geographic team structure. Ensure team members at all levels have consistent and accurate information on status, priorities, and gaps and decisions/actions.
- Work in a vibrant matrix based environment and interact with the broader R&D organization and our partners at Calico.
- Guide teams on overall product development plans; leverage medical and scientific expertise, knowledge of compliance and regulatory requirements, and successful clinical trial management principles, facilitate analysis and decision making across the matrix team. Be actively involved in project-related education of investigators, study site personnel, and AbbVie study staff.
- Oversight of oncology early development Calico study teams, monitoring careful review of the science, program and study integrity. Help with review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule, help design clinical proof of concept studies. Interact with the larger AbbVie Clinical Operations organization.
- Primary responsibility for and ownership of rapid advancement of Calico collaboration based Discovery programs through clinical proof of concept.
- Interact with our Regulatory, CMC, toxicology and Discovery scientists.
- Will have broad oversight on OED stage Calico Asset Strategy Teams and help build a plan of advancing a broad spectrum of oncology assets.
- Responsibility for development of a rigorous, cross-functionally-aligned, vetted asset strategy, PKPD, biomarker, clinical development plans with full consideration of contingencies and alternative approaches.
- Serves as an in-house Oncology Calico expert for multiple assets.
- Leading cross-functional collaborations within R&D and with Calico.
- 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 strategic 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 Development Plans 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 with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- Minimum of 7+ years of experience. Preferred 9+ years Oncology experience in Biotech/Pharma industry or a proven track record of being a Physician Scientist.
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to run a complex multi-disciplinary 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.
- Strong financial acumen to give senior leadership strategic insights and analysis that support Program decisions/outcomes.
- 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.
- Exceptional communication skills; develop and deliver oral and written communication materials demonstrating exceptional English skills, ability to tailor information for multiple audiences/levels of the organization as well as with external stakeholders.
- Ability to exercise judgment and address complex problems and create solutions for one or more projects.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 25 % 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.