Executive Director, Clinical Pharmacology
- Posted: over a month ago
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening disease. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins of proteins as drug targets.
We are currently seeking an experienced, collaborative, and strategic scientific leader to lead and optimize Eikon’s emerging clinical pharmacology function.
You are a highly skilled quantitative drug developer, with a strong, integrated understanding of the strategic and regulatory elements of drug development. You are agile of mind, an outstanding communicator, and proficient in planning, directing, and coordinating a variety of projects in parallel. You are a person of vision and current on new development and technological advancement in clinical pharmacology.
What You’ll Do
- Provide leadership to the clinical pharmacology function and multi-disciplinary study teams: Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all clinical pharmacology projects.
- Ensure technical excellence, deep scientific rigor, and operational effectiveness within quantitative clinical pharmacology. Oversee and directly apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications.
- Provide high quality clinical pharmacology components at project level (including clinical development plan), at study level (including protocols, analysis plans, clinical conduct, and study reports) and to global regulatory submission documents (IB, IND, NDA, MAA).
- Frame critical drug development questions for optimizing model-based development via translational PK/PD, population pharmacokinetic, exposure-response, quantitative system pharmacology and disease progression models.
- Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results. Conduct and report quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
- Ensure that the clinical pharmacology strategy serves the overall objectives of the clinical program and is designed and executed to the highest scientific standards and delivers the data required to fulfill regulatory requirements.
- Responsible for implementing clinical pharmacology best practices and processes.
- Identify opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy, and safety.
- Mentor, train, and manage junior level staff.
- MD, PhD or PharmD in a relevant health sciences discipline, with strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, literature meta-analyses, clinical trial simulations, statistics).
- Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.
- Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for small/large molecule drug development.
- Strong quantitative skills, conceptual, technical and hands on development expertise with modeling and simulation activities.
- Must demonstrate 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 created business impact.
- Excellent verbal, written skills, and ability to convey moderately complex technical information clearly to other are required.
- In-depth knowledge and understanding of pharmacokinetic regulatory requirements for US and EC are required.
- Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a collaborative and innovative team.
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
AddressNew York, NY
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