Associate Medical Director/Medical Director, Oncology Early Development
Company: Association of Clinicians for the Underserved
Location: Redwood City
Posted on: February 17, 2021
Associate Medical Director/Medical Director, Oncology Early
Development About AbbVie
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
- 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
- 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
- Associate Medical Director: Minimum 1-3 years of industrial
- 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
- Proven leadership skills and ability to bring out the best in
others on a cross-functional global team. Must be able to lead
- 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
- Must possess excellent oral and written English communication
- Ability to exercise judgment and address complex problems and
build solutions for one or more projects.
**Equal Opportunity Employer
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive
hours in an 8 hour day)
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.
1420 Spring Hill Road
McLean, VA 22102
Keywords: Association of Clinicians for the Underserved, Redwood City , Associate Medical Director/Medical Director, Oncology Early Development, Executive , Redwood City, California
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