Director, PK Sciences (Cambridge, MA) job in Cambridge
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS) partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology, and bring it to bear on drug discovery and development challenges throughout R&D. |
The Director, PKS will develop and implement clinical pharmacology strategies to support small and large molecule drug development from early discovery through late clinical development. This unique role will provide matrix leadership to collaborate, align and influence across the cross-functional team to identify and mitigate key project issues related to the pharmacokinetic sciences [PKS] discipline (PK, PK/PD, metabolism and clinical pharmacology).
The incumbent will be expected to proactively contribute to develop candidate drug products from early discovery through late clinical development providing expert pharmacokinetic / drug metabolism and clinical pharmacology input.
As a PKS Project Team Member [PTM], this individual will design PKS strategy for assigned program(s) and coordinate pharmacokinetic / pharmacodynamic/ drug metabolism related elements for pre-clinical and/or clinical projects. In addition, this individual will provide input to Target Product Profile, identify potential project issues as well as represent PKS on Global Program Team(s) or early project teams.
The Director, PKS will be responsible for the PK, 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 within agreed timelines and which meet regulatory requirements as well as prepare appropriate responses to Health Authority questions (globally); oversees or perform PK and PK/PD analyses using a variety of tools and approaches and integrate, interpret and report data to project teams and other customers.
The Director will:
Lead or participate in PKS project teams and coordinate with appropriate sub-team members to ensure implementation of project strategy and/or prepare summary documentation.
Evaluate in-licensing opportunities and Due Diligence activities as required
Attend meetings with investigators, outside experts, and health authorities
Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance), and train other PKS associates; may act as technical / scientific subject matter expert in key clinical pharmacology / PK sciences related area; may publish internally and/or externally as main contributor; co-author patent applications; review current literature in own discipline and related areas.
The incumbent will also be expected to adhere in strict accord to the appropriate SOP, GCP, GLP, GMP and other guidelines.*EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
This role requires a PhD / Pharm.D. level scientist with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related biologic back ground.
This position requires 10+ years in a drug development function with a minimum of 5 years of experience in a lead role overseeing clinical pharmacology strategy of compound development.
The successful candidate will have extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) and knowledge of regulatory requirements.
In addition, the candidate will have demonstrated success in a matrix leadership role leading and influencing cross functional project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences. The successful candidate will also need to have a proven record as a leader with good negotiation, organizational and project management skills.