Assist in the development of TM & ECD study protocols, including the development of the schedule of activities and associated procedures, ensuring they are implementable, and procedures are clinically appropriate and the operational aspects of the study are clearly outlined in the protocol’s investigational plan. Serve as the point of contact for study-related contract service providers (vendors), including the study contract research organization (CRO) and/or clinical study sites or other vendo... more details
Job Description
The Position
The Associate Director, Translational Medicine and Early Clinical Development (TM & ECD) is responsible for overseeing the operational aspects of translational medicine and early clinical development studies and will report into the Executive Director, Translational Medicine and Early Clinical Development Operations. As the operational lead for individual studies, the Associate Director serves as the primary point of contact for contract service providers (vendors) involved in study-related activities and for ensuring that the execution of all study aspects follow Organon SOPs. The Associate Director collaborates with internal and external scientific and medical experts to plan and execute studies that support TM & ECD program strategies and plans; author, review and/or manage a wide variety of activities, including for example, study protocols and schedule of activities, informed consent forms, case report forms, study reference manuals, monitoring plans, data management plans, and site initiation visit meeting presentations. The Associate Director will manage the clinical study team and help coordinate meetings and interactions with vendors to optimize communication and smooth execution of TM & ECD studies. The Associate Director also manages internal teams to ensure database lock activities occur in a timely manner, coordinate activities for delivery of top-line data, as necessary, and review clinical study reports in accordance with overall project timelines.
Responsibilities
Assist in the development of TM & ECD study protocols, including the development of the schedule of activities and associated procedures, ensuring they are implementable, and procedures are clinically appropriate and the operational aspects of the study are clearly outlined in the protocol’s investigational plan.
Serve as the point of contact for study-related contract service providers (vendors), including the study contract research organization (CRO) and/or clinical study sites or other vendors, as appropriate.
Serve as the TM & ECD clinical study team lead coordinating internal and external cross-functional communication and documentation to optimize collaboration and ensure TM & ECD studies are executed with the highest standards and are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
Manage vendors to execute TM & ECD studies in accordance with contracted scope, costs and timelines; actively engage with vendors on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities.
Prepare vendor proposal documents and with cross-functional project team, solicit and evaluate competitive bids; lead contracting process with selected CROs, including purchase order requisitions and routing contracts for approval.
Identify risks to ensure successful execution of TM & ECD studies, proactively communicate risks to internal and external cross-functional teams and vendor teams, and lead the clinical study team to develop and implement risk mitigation strategies and tactics to enable study completion in accordance with approved timelines and plans.
In collaboration with the Executive Director, Translational Medicine and Early Clinical Development Operations, develop processes to support TM & ECD development strategies, studies, and plans.
Attend and actively participate in assigned clinical study teams and vendor meetings.
Lead TM & ECD clinical study or study management teams.
Lead efforts to obtain requests for proposals and oversee the study initiation and close-out activities for TM & ECD studies.
Oversee the outsourced activities, from vendor selection to completion of a study.
Engage and communicate effectively with study site personnel and investigators.
Required Education, Experience and Skills
Bachelor’s degree or higher in natural or health sciences (pharmacology, biology, pharmaceutical sciences, or related sciences).
Excellent organizational and project management skills to facilitate optimal clinical study team and/or sub-team functioning and cross-functional collaboration.
Strong knowledge of clinical research process, including working knowledge of GCP, ICH and other regulatory standards.
Skillful at technical writing with an ability to precisely and accurately summarize clinical and scientific information in written format.
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).
Eager to learn with a collaborative, team-oriented mindset.
Functional capability with various software platforms including Microsoft Word, PowerPoint, Excel.
A minimum of five to six years' experience in translational medicine and early clinical development within the pharmaceutical or biotech industry with a proven track record for competence and efficiency in overseeing the execution of TM & ECD (early phase 1 – 2a) studies.
Experience supporting the early development function by contributing to SOP working groups and other process-related teams and/or sub-teams.
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Preferred Experience
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.
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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)
$124,000.00 - $210,700.00
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:
Remote Work
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
2
