You will join a team of scientists supporting late stage oncology clinical development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team for alate-stage oncologyprogram.ROLE RESPONSIBILITIES
- Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team as appropriate.
- Participate in implementing model based drug development using quantitative approaches to address complex questions arising during drug development
- Responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team including plan, design and oversee clinical pharmacology studies with operational assistance from operations colleagues
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc.
- Directs the planning of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics (as relevant).
- Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation.
- Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings.
- Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
Nice To Have
- PhD or PharmD and 4+ years of related experience
- Experience applying pharmacokinetic andpharmacokinetic-pharmacodynamicconcepts, includingmodeling and simulation to clinical trial design.
- Clinical drug development experience in oncology or other therapeutic area
- Strong communication skills--written, verbal and presentation
- Strong technical proficiency with pharmacokinetic software (e.g., WinNonlin, NONMEM, S+Plus, R)
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Eligible for Employee Referral Bonus
Relocation assistance may be available based on business needs and/or eligibility.
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