Associate Director/Senior Principal Scientist, PK Sciences, Therapeutic Areas (Dual Level Posting)

Novartis • San Diego, CA

1d • Hybrid

About The Position

We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies to support the pursuit of transformative new medicines through late clinical development. Our unique organizational structure enables colleagues to work seamlessly in the translational and/or clinical space, offering opportunities for development and bench-to-bedside-to-bench translation. The scope of the role potentially includes small molecules, biologics/therapeutic proteins, RNA based therapeutics, and/or cell therapies serving primarily the neuroscience therapeutic area. This position drives close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), and Operations through PK science sub-teams to achieve a holistic and integrative perspective of the ADME/clinical pharmacology properties of candidates and drugs. This role reports to Neuroscience, Therapeutic Area Head in PK Sciences within Translational Medicine (TM) in Biomedical Research. PKS is a global organization situated within Translational Medicine (TM), the clinical research arm of Biomedical Research within Novartis. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise-wide organization, working across both Biomedical Research and the Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology as well as disciplines as part of the research Development commercial collaboration.

Requirements

• Ph.D. / Pharm.D. with relevant experience (minimum 5+ yrs) in clinical pharmacology, drug metabolism and pharmacokinetics or a related background in an industry setting.
• Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.
• Demonstrated success in working in a cross-functional, matrixed, project-team environment.
• An influential Team player and talented negotiator with strong oral and written communication skills.
• Ability to set priorities within and have strategic overview over a focused portfolio
• Proven record of mentorship and/or people management

Nice To Haves

• Early and late development with core clinical pharmacology expertise is preferred.
• Experience in Clinical pharmacology with neuroscience preferred.
• Hands-on project experience with Artificial intelligence (AI) / Machine Learning (ML) approaches is a plus
• Prior experience in clinical pharmacology, clinical development and global regulatory submissions, especially IND’s/NDS’s/BLA/s in neuroscience is a preference

Responsibilities

• Independently represent the PK Sciences function in cross-functional project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate
• Leads a PK Science Sub team with interdisciplinary representation of the major functions from within PK Science and beyond
• Ensures implementation of project strategies and monitors timelines, objectives, and budgets for assigned projects
• Present projects at various institutional review and approval boards
• Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late clinical development
• Provide PK, dosage, PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to global Health Authority questions
• Is able to provide managerial reviews for a focused project portfolio
• Supports strategic initiatives to create a top-performing organization
• Encourages the use of artificial intelligence (AI) / machine learning (ML) approaches to enable model guided molecular design, preclinical and clinical data automation, authoring regulatory documents, and the use of predictive models
• Is a mentor to junior associates in the organization

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree