Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. 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. Together, we are striving to outsmart cancer.
Lead and manage the projects effectively and to ensure they are delivered on time, on budget, and to agreed quality standards.
Conduct team meetings with internal and external stakeholders ; develop agenda, meeting minutes, and action items for team members .
Follow the Quality Assurance and Regulatory requirements for the assigned project.
Ensure project scope is clearly defined; develop and manage project plans to meet deliverables .
Responsible for identifying critical project issues and risks, and timely communication to senior leadership
Resolves project issues by working with team members , project customers, and others as appropriate.
Act as point of contact for project reporting & update .
Maintains direct interaction with CMC ,R&D , - regulatory, and operations.
BS/BA degree in health sciences required
Experience in pharmaceutical industry
Minimum of 3-5 years project management in R&D or drug development experience
Knowledge of GMP, quality systems and regulatory standards requirements for Pharma industry
Past experience in process development, GMP manufacturing operations and other related CMC activities is a plus.Demonstrated leadership skills in collaborating and influencing cross-functionally
Strong organizational and interpersonal skills
Strong planning and execution skill
Excellent communication and time management skills
Strong written and oral communication skills
Critical thinking/problem-solving skills
- Demonstrated competencies in all aspects of project management