Associate Director, Clinical Science
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.
To learn more about us, please visit us at http://www.pharmacyclics.com/
General Position Summary/Purpose:This position is responsible in conjunction with the Medical Monitor for the scientific planning, monitoring and reporting of assigned clinical trials. The Clinical Research Scientist assists the cross-functional study team (SMT) addressing protocol questions, including preparation of clinical study protocols, patient informed consents, and other core documents which are central to clinical and scientific trial conduct. This position reports to a Clinical Science Project Lead. Key Accountabilities/Core Job Responsibilities:
- Support the medical monitor and/or Head of Therapeutic Area with the development of program-level documents, including but not limited to clinical protocols, clinical study reports, abstract and manuscripts, presentations, investigator brochures, and various other internal and external documents and communications as needed
- Coordinate Steering Committee meetings as well as independent DMC meetings
- Assist clinical team addressing protocol questions, on study protocol related questions from clinical sites. Assist with protocol and study conduct training of CRAs, study coordinators, and investigators.
- Functions as primary medical monitor on study protocols as appropriate
- Works with project management to coordinate review cycle process as appropriate
- Assist with responding to regulatory questions as well as respond to site IRB or EC questions
- Responsible for compiling clinical content and maintenance of various clinical components of regulatory documents, including Briefing documents/EOP2 packages/INDs/BLAs/NDAs
- Assists in competitive intelligence and application to clinical protocol development
- Serves as the clinical representative on various project sub-teams and addresses a broad range of problems, including review of medical affairs documents (protocols and publications) in the assigned Therapeutic Area
- Effectively collaborate with cross-functional internal groups and external partners, as well as work effectively with external key opinion leaders
- Ensures that the clinical elements of documents are of quality, accuracy and format and comply with laws, regulations and corporate standards
- Develop and maintain departmental processes, policies, SOPs and associated documents as needed
- Performs data listing and patient profile review to support programs in the Therapeutic Area.
Requires strong writing and verbal communication skills
Requires ability to work closely and effectively across functions
Requires knowledge and experience in clinical trial conduct
BS, MS or equivalent (Years of Experience in the industry)
PhD, PharmD, MD or equivalent