Pharmacokinetics Project Leader

Johnson & Johnson•Spring House, PA

69d•$137,000 - $235,750

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.â Learn more at https://www.jnj.com About innovative medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Pharmacokinetics Project Leader to be located in Spring House, PA or La Jolla, CA. Purpose: We are looking for an experienced Pharmacokinetics Project Leader to join our Translational Pharmacokinetics, Pharmacodynamics and Investigational Toxicology (TPPIT) group, part of Preclinical Sciences and Translational Safety (PSTS) organization. The successful candidate will assume a leading role in driving Non-Clinical PK, ADME and PK/PD strategy and execution to enable timely recommendations for discovery programs, drive preclinical development through IND/CTA filing, and support non-clinical and translational PK deliverables for clinical programs. You will be responsible for: Applying relevant pharmacokinetics (PK) principles, driving relevant experiment and modeling strategy, and integrating PK/ADME/PD data with pharmacology and toxicology profiles to effectively inform program strategy and decisions. Developing a deep understanding of the program biology/pharmacology and being an active partner on project teams, providing scientific leadership in the design and analysis of key experiments. Working closely with cross-functional teams, providing technical direction in supporting program decisions, compound development plans, and regulatory submissions. Authoring relevant sections of internal and regulatory submission documents and reports. Engaging our global TPPIT and PSTS functional areas to ensure the best science is used to support programs. Working across multiple therapeutic areas and modalities (cell, proteins, ADCs, peptides, small molecules and RNA), and representing the program and TPPIT function at project review, portfolio governance and in Health Authority interactions.

Requirements

A PhD with 6+ years of relevant experience OR a Master's degree with 8+ years of relevant pharmaceutical experience is required.
Strong understanding of PK, ADME and PK/PD, with a track record of scientific achievements and project influence is required.
Ability to translate data into project relevance, as part of anticipating and mitigating program challenges is required.
Experience with quantitative modeling in describing preclinical and/or clinical PK/PD is required.
Excellent interpersonal, organizational, oral/written communication and teamwork skills are required.
Experience in drug development, including writing of DMPK sections for regulatory documents (e.g., IND/CTA/IB etc) are required.

Nice To Haves

Prior experience in biologics modalities is preferred.

Responsibilities

Applying relevant pharmacokinetics (PK) principles, driving relevant experiment and modeling strategy, and integrating PK/ADME/PD data with pharmacology and toxicology profiles to effectively inform program strategy and decisions.
Developing a deep understanding of the program biology/pharmacology and being an active partner on project teams, providing scientific leadership in the design and analysis of key experiments.
Working closely with cross-functional teams, providing technical direction in supporting program decisions, compound development plans, and regulatory submissions.
Authoring relevant sections of internal and regulatory submission documents and reports.
Engaging our global TPPIT and PSTS functional areas to ensure the best science is used to support programs.
Working across multiple therapeutic areas and modalities (cell, proteins, ADCs, peptides, small molecules and RNA), and representing the program and TPPIT function at project review, portfolio governance and in Health Authority interactions.

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Company's consolidated retirement plan (pension) and savings plan (401(k)).
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours