Director, Clinical Pharmacology Lead

The Position

• This position can be 100% remote in the US
• There are 2 openings

The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology strategy supporting development assets within the Organon portfolio. This position sits within the Translational Medicine and Early Development (TMED) department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale, study design and oversight of phase 1 to 2a study protocols, in collaboration with internal (biostatistics, clinical operations) and external (contract research organization [CRO], bioanalytical and/or modeling vendors) colleagues.  The Clinical Pharmacology Lead will ensure the scientific and clinical pharmacology components of study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.  The Clinical Pharmacology Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction with the TMED Operations Lead) and reporting thereof. 

The Director will work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control (CMC), project management and other partner groups as part of a development team to develop strategic early development plans (EDP).  Importantly, the EDP will represent an integrated plan that leverages clinical pharmacology principles, such as establishing an exposure-response relationship to optimize dose selection, pharmacokinetic and pharmacodynamic modeling and simulation and biomarker strategy, as appropriate, to ensure program efficiency and facilitate data-based decision making to accelerate the development to the extent feasible.  The Clinical Pharmacology Lead will facilitate and provide oversight thereof while ensuring the scientific and data integrity, rigor and quality thereof.   The director may represent the Clinical Pharmacology function in asset development teams (ADT) across the portfolio including drug candidates and lifecycle management (LCM) for mature products or be Clinical Pharmacology representative for a franchise.

The Clinical Pharmacology Lead also will be responsible for authoring modules 2.7.1 and 2.7.2 and contribute to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to agency questions and other regulatory documents as applicable.

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.

Required Education, Experience and Skills

• MD or PharmD (Post-Doctoral Fellowship preferred), clinical training preferred
• Board certification in clinical pharmacology a plus.
• 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.
• A minimum of four 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).
• Experience in Women’s Health strongly preferred.