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Organon · 3 months ago

Director, Clinical Pharmacology Lead

Plymouth Meeting, PA

Full-time

Onsite

Director/Executive

$152K/yr - $259K/yr

6+ years exp

Organon is a $6.5 billion global healthcare company focused on women's health solutions. The Director, Clinical Pharmacology Lead will be responsible for devising clinical pharmacology strategies, overseeing study protocols, and collaborating with cross-functional teams to ensure scientific integrity and regulatory compliance.

Health CareMedical DevicePharmaceuticalWomen's

No H1B

Responsibilities

Ensure early development plans incorporate a biomarker strategy and leverage PK/PD modeling to establish an exposure-response relationship that optimizes dose selection, facilitates the efficiency of the overall program development plans and enables fastest to market opportunities

Represent the Clinical Pharmacology function or serve as subject matter expert for translational medicine and clinical pharmacology on ADTs responsible for devising and executing on the EDP (TMED scope: first-in-man to Phase 2a), late-stage development plans or, for mature or commercial assets, LCM plans

Participate in or lead ADT sub-team meetings, as appropriate

Responsible for the design, execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with the program plans and serve as an active member of the clinical study team

Provide input to vendor selection and provide vendor oversight and management for TMED studies, in collaboration with the TMED operations lead, bioanalytical or modeling leads, procurement and clinical business operations or other internal cross-functional partners, as appropriate

Responsible for authoring translational medicine and clinical pharmacology components of TMED study protocols, clinical study reports, Investigator Brochures, briefing books, IND subsections, submission modules and other regulatory documents

Provide clinical pharmacology subject matter expertise and lead the authoring of responses to health authority questions and inquiries

Author the translational medicine and clinical pharmacology components of study protocols, clinical study reports, Investigator Brochures, briefing books and other regulatory documents such as IND subsections and submission modules

Participate in health authority meetings, as necessary

Prepare presentations TMED plans for governance meetings

Attend and actively participate in assigned asset development and sub-team meetings, clinical study team, modeling and vendor meetings

Contribute to scientific communication and events

Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed

Qualification

Clinical PharmacologyTranslational MedicinePharmacokineticsPharmacometricsRegulatory KnowledgeTechnical WritingCollaborationMicrosoft WordMicrosoft PowerPointMicrosoft ExcelCommunication Skills

Required

MD or PharmD (Post-Doctoral Fellowship preferred), clinical training preferred

Board certification in clinical pharmacology a plus

A minimum of six years of experience in the pharmaceutical or biotech industry with a focus in early clinical development, translational medicine and/or clinical pharmacology

Post-doctoral, industry-sponsored PharmD Fellowship strongly preferred (for PharmD candidates)

Extensive working knowledge of small molecule drug development, with specific expertise in translational medicine and clinical pharmacology principles including pharmacometrics, drug metabolism and human ADME, biomarkers, exposure-response assessment, and biopharmaceutics

Demonstrated technical and scientific knowledge of pharmacokinetics, pharmacometrics, and clinical pharmacology as disciplines to facilitate clinical development of drug candidates or in the assessment of business development opportunities

Good working knowledge of regulatory guidance and requirements pertaining to early clinical development including clinical pharmacology guidelines and principles, exposure-response analysis guidance and principles pharmacokinetic and pharmacodynamic modeling (including population pharmacokinetic modeling), nonclinical guidelines and principles, biopharmaceutics guidelines, other clinical development guidance, as appropriate

Working knowledge of GCP, ICH and other regulatory standards

Ability to understand and interpret clinical and scientific information and data and communication thereof in written or oral form appropriate for the receiving audience

Skillful at technical writing with an ability to clearly and accurately summarize clinical and scientific information in written format

Track record of effective functional representation on product development teams

Excellent verbal and written communication skills

Collaborative mindset with a positive, transparent and inclusive approach as a representative or leader of cross-functional team(s)

Functional capability with various software platforms including Microsoft Word, PowerPoint, Excel