Director, DMPK

Description:

We are seeking an experienced Director, DMPK to join Mariana’s Preclinical Development organization, advancing personalized medicine and radiopharmaceuticals.

Illustrative Breadth of Responsibilities:

• Create a vision for the ADME/DMPK function at Mariana Oncology and effectively communicate it throughout the company
• Develop and executing ADME/DMPK strategies aligned with platform, programs, and company goals
• Lead the DMPK team in the execution of all bioanalytical and preclinical ADME/DMPK studies using either in house resources or CROs
• Collaborate with Discovery Scientists and project leaders in establishing ADME/DMPK profiles during drug discovery, drug candidate selection though transition into development
• Plan and oversee mechanistic PK/PD modelling efforts at Mariana. Manage collaboration and consultants to perform mechanistic PK/PD as needed
• Oversee Dosimetry efforts to enable decision-making for programs in discovery and preclinical development
• Represent DMPK on a variety of interdisciplinary teams and corporate governance forums
• Ensure delivery of all reports and appropriate sections of regulatory documents to support INDs, NDAs and other world-wide regulatory dossiers
• Act as SME for ADME/DMPK, modeling and dosimetry at both internal and at external meetings

Requirements/Skills:

• Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background
• 6+ years’ experience in industry R&D environment for PhD/PharmD or 9+ years’ experience in industry R&D environment for BS/MS
• 2+ years’ leading relevant functional area(s), either in drug discovery or clinical development
• Demonstrated mastery in the field and be recognized as an expert within and outside the organization
• In-depth experience with Phoenix WinNonlin and/or other relevant analytical tools
• Broad capabilities across pharmacokinetics, pharmacodynamics, ADME, modeling, and clinical pharmacology are essential to this individual’s success
• Experience with radiopharmaceuticals, peptides, and/or oncology is preferred
• Leader of cross-functional process initiatives
• Strong written and oral communication skills
• Candidate should have a strong track record of independently authoring and providing regulatory guidance to team members on technical reports/ summaries, suitable for inclusion in registration dossiers (IB, IND, NDA etc) and managing correspondence with regulatory authorities

Mariana Oncology’s Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions

EEO Statement

Mariana Oncology is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.