Janssen R&D, a member of Johnson & Johnsons Family of Companies, is recruiting for a Senior Scientific Director - US Head Development Project, for the Department of Drug Metabolism and Pharmacokinetics (DMPK), located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolic diseases and global public health. Please visit http://www.janssenrnd.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Department of Drug Metabolism & Pharmacokinetics is a critical part of the Discovery Sciences organization in Janssen R&D and is committed to the delivery of high-quality clinical candidates and ultimately approved therapeutic solutions for all Therapeutic Area’s (TA) Janssen R&D is committed to. We are currently seeking an outstanding individual to join our team as a Senior Scientific Director - US Head Development Project Leaders.
DMPK Development Project Leaders will represent DMPK (as subject matter experts) on multidisciplinary projects and are responsible for providing scientific leadership and strategic direction (including regulatory) to projects they are assigned to. This position will be based in Spring House, PA and will report to the Global Head DMPK development project leaders.
Lead/Coach/Mentor a team of US based DMPK development project leaders and take on responsibility as DMPK project leader themselves as well for a limited number of projects.
Serve as the subject matter expert for DMPK during all stages of drug and development (including submissions).
Collaborate closely with key stake-holders such as Clinical Pharmacology, Non Clinical Safety, Pharmaceutical Sciences and Regulatory and identify opportunities for project impact.
Establish DMPK strategies that align with program goals and meet regulatory requirements.
Design, interpret, and report all preclinical DMPK-related studies
Effectively communicate DMPK-related data and their relevance to multidisciplinary project teams, management, regulatory authorities, and potential partners.
Ph.D. in pharmacokinetics, drug metabolism, or related discipline with a minimum of 10+ years of relevant industrial experience in the evaluation of small molecule therapeutics. Experience in other therapeutic modalities such ASO, siRNA, peptides etc.etc. is highly appreciated.
Broad understanding of various DMPK relevant areas such as physicochemical properties, drug metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation and analytical sciences.
Understanding of PBPK/PD modelling will be desirable but not essential.
Ability to translate data into project relevance as part of anticipating and/or mitigating project challenges.
Demonstrates ability to integrate data from multiple sources into a rational understanding of drug disposition.
Good negotiation and influencing skills, priority setting and adherence to project and departmental timelines.
A strong understanding of regulatory guidelines for DMPK packages to support drug development (from First-in-Human studies to submission)
Evidence of leadership in the DMPK field and a proven track record of scientific achievement & project influence, including ability to influence external scientific and regulatory practices through publication and other interactions.
Excellent verbal and written communication skills as well as strong interpersonal skills are essential.
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