Job Description

The Position

This position can be 100% remote in the US

The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical development & translational medicine development strategy supporting development assets within the Organon portfolio. The TMED 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). The TMED Lead will ensure the scientific and clinical pharmacology components of study protocols are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans. The TMED 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 TMED plans. Importantly, the early development plan (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 a biomarker strategy, as appropriate, to ensure program efficiency and facilitate data-based decision making to accelerate the development to the extent feasible. The TMED Lead will facilitate and provided oversight thereof while ensuring the scientific and data integrity, rigor and quality thereof. The director may represent the TMED function in asset development teams (ADT) across the portfolio including drug candidates and lifecycle management (LCM) for mature products or be TMED representative for a franchise.

The TM & ECD 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.

• May represent the TMED 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 TMED 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.

• Excellent working knowledge of 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.

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

Secondary Language(s) Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully

Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$150,600.00 - $256,300.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R529557