The Associate Director, Pharmaceutical Development, Strategic Liaison, will be responsible for coordinating the Analytical and Formulation Development support to ENHANZE platform partnered programs. The successful candidate will represent Analytical and Formulation Development and work collaboratively in multidisciplinary teams within the organization and across ENHANZE partner organizations to coordinate, influence and advise on strategic and operational efforts to ensure alignment and seamless execution of the ENHANZE strategies.
Typically, partnered programs are complex in nature requiring the conception of elaborate strategies and development plans. They may encompass pre-IND stage, clinical-stage development, and post marketing activities. The role is expected to exhibit strong organizational, technical, interpersonal, and leadership skills to allow successful collaboration with multidisciplinary working groups both within the organization and with Alliance Partners. An essential part of the collaboration requires face to face meetings with Partners, which the ENHANZE Strategic Liaison will be expected to attend.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
Contribute for multiple partnered projects to establishing phase appropriate product requirements, defining development strategies and milestones to meet the requirements, and operationalizing development plans to achieve the defined milestones
Partner with the formulation and analytical Subject Matter Experts (SMEs) within the organization to design and execute formulation, analytical, and drug product compatibility studies in support of development plans
Collaborate with SMEs across organizations to contribute to the design of shared studies, ensure quality and timely execution internally, and share results with Partners through reports and presentations
Collaborate cross-functionally within the organization on supporting partner global regulatory submissions by authoring and reviewing sections, as well as responding to requests for information
Contribute to optimizing the model used to support partnered programs through the development of guidance documents and presentations to further harmonize practices in areas such as drug product compatibility/stability studies, drug administration instructions, specification settings, and utilization of ENHANZE related analytical assays.
Partner internally with the Alliance Leader and/or Program Leader and functional team members to help achieve optimal team performance and timely achievement of program milestones
Build and maintain productive relationships with key personnel both internally and with Alliance Partners
Contribute to and potentially lead Alliance CMC sub-team meetings; document meeting minutes, actions, and key decisions
Communicate and follow up on action items and key deliverables through their closure/completion
Monitor and suggest ways to accelerate project completion
Evaluate project delays and roadblocks and propose rational and creative solutions
Coordinate budget and resources for formulation and analytical internal support to partnered projects
Provide regular updates on project status for key decisions, timelines and deliverables to the Alliance project team and to the Product Development function
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Minimum of a Masters degree with 10 years of experience in the pharmaceutical and biopharmaceutical industry in CMC-related functions (an equivalent combination of experience and education may be considered)
Ph.D. in Pharmaceutical Science or related field is preferred
Strong scientific background with broad knowledge and experience in CMC development of biologics
Preferred experience with statistical analysis and software, and design of experiment approaches, particularly as applied to formulation and analytical method development
Well established knowledge of GMP and QbD principles, FDA guidelines, ICH guidelines, EU guidance, etc.
Strong proficiency in writing and reviewing CMC sections for US and international regulatory submissions highly preferred.
Demonstrated ability to operate within a matrix organization and to manage multiple organizational interfaces and stakeholders, including meeting facilitation.
Demonstrated excellence in communication, negotiation, presentation, analytical thinking and problem-solving skills.
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: N/A
INTERNAL AND EXTERNAL RELATIONSHIPS:
Effectively interface within line function and with other line functions within Halozyme (e.g., Alliance, Regulatory Affairs, Quality, CMC Operations, Commercial, Clinical, Nonclinical, etc.)
Manage relationships with Alliance counterparts
Employer will assist with relocation costs.
Halozyme is a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapies that target the tumor microenvironment. Our lead proprietary program, investigational drug PEGPH20 (pegvorhyaluronidase alfa), applies a unique approach to targeting solid tumors, potentially providing increased immune response and tumor access for co-administered anti-cancer therapies.
In addition to our proprietary product pipeline, Halozyme has value-driving partnerships with leading pharmaceutical companies, including Roche, Pfizer, Janssen, Baxalta, AbbVie, Eli Lilly, Bristol-Myers Squibb and Alexion for our ENHANZE® drug delivery technology, which enables biologics and small molecules currently administered intravenously to be delivered subcutaneously and may provide additional benefits. We are headquartered in San Diego.