Pharmacokinetics Project Leader

Johnson & Johnson • Spring House, PA

71d • $137,000 - $235,750 • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. 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. We are searching for the best talent for a Pharmacokinetics Project Leader to be located in Spring House, PA or La Jolla, CA. 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.

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.
• 401(k) and pension plan.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees