Senior Project Leader / Project Leader, Oncology Early Development
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 efforts with a focus on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these multiple sites. They combine their expertise in 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 site either in North Chicago, IL or Redwood City, CA.
We are searching for a Project Leader to join Oncology Early Development (OED).' This is a unique opportunity to lead innovative first in-class, cutting edge programs, combined with the opportunity to lead and mentor cross-functional'teams that are responsible for the development of oncology early development therapeutic programs. 'The successful candidate will work with cross-functional subject matter experts who work across AbbVie sites and be responsible for advancement of programs into AbbVie’s full development oncology portfolio.'In this role, you will report directly to the Group Project Leader in OED and will join an experienced team with a strong track record in developing biotech products.''As the Project Leader (PL), you are the final decision-maker and champion of your programs.' You will represent the team/program at governance, and to internal and external stakeholders.' To be successful in this role, you need a deep understanding of oncology drug development and be able to articulate the best decisions for the program to the team and to senior management. 'The focus will be zeroing in on the science, clinical path, and management of your matrix team in order to reach those decisions. You will be a scientific leader for your programs.
Key Responsibilities Include:
- Creating competitive early development strategies, comprised of clinical, regulatory, commercial and manufacturing strategies, and champion the development programs through major stage gates.
- Run a team to generate and drive the strategy for programs, and specific actions on how and what to execute on. Each program is based on cutting edge science, to generate, deliver and interpret high-quality clinical data supporting overall products.
- Guide IND enabling preclinical studies, help draft and review regulatory documents (such as INDs), Investigator Brochures and clinical protocols.
- Drive a program to a clear Go or No go decision; effectively and efficiently executing on the program towards clinical proof of concept.''Being able to state a clear No go decision based on lack of activity in the right disease indication is also needed.
- Responsible for presenting to AbbVie senior management team and other key stakeholders throughout the organization.
- Travel will be required between AbbVie sites as well as some travel to visit investigators and key conferences such as ASCO, AACR, ASH, SITC, etc.
- PhD, MD or PharmD with a strong scientific background in oncology drug development (basic, translational and/or clinical); and experience in designing and/or conducting oncology early clinical trials.
- Knowledge of preclinical and clinical'drug'development is a prerequisite, as is knowledge of standard of care in Oncology and emerging therapies.
- Strong understanding of manufacturing, Regulatory, oncology clinical landscape.
- Excellent verbal and written communication skills and ability to lead cross functional project teams.
- Doctoral-level degree required
- Senior Project Leader - Minimum 8 years (10 years preferred) of experience in an academic, hospital or pharmaceutical/biotech setting.'
- Project Leader - Minimum 5 years (8 years preferred) of experience in an academic, hospital or pharmaceutical/biotech setting
- Preferred drug development expertise/experience in biotech/pharma industry
- Proven track record of leading successful projects with
- Experience leading cross-functional development teams
- Knowledge of Immuno-Oncology, apoptosis mechanisms, cancer stem cells, small and large molecule drug development is required.
- Clinical experience in managing Ph1, Ph2 and/or Ph3 studies is a plus.
- Adept at leading and managing team members in a matrixed environment that includes subject matter experts in clinical, project management, regulatory, commercial, manufacturing, discovery research.
- Strong leadership skills, business acumen and be able to think and function independently.
- Strong understanding of scientific concepts and have experience in translational research and biomarker development.
- Ability to lead and motivate team members from across functional areas; must be able to lead through influence and bring out the best in others. Ability to delegate appropriate accountability and decision-making to supporting teams and functions.
- Excellent written and oral presentation skills in the English language
Equal Opportunity Employer Minorities/Women/Veterans/Disabled