Clinical OB/GYN Device Development Lead

Company: Organon & Co
Location: Jersey City
Posted on: June 18, 2022

Job Description:

Job DescriptionOrganon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets.It's going to be an exciting future-come be a part of it!Executive Director, Women's Health - Clinical Lead - OB/GYN Device DevelopmentThe Executive Director, Women's Health Clinical Lead is responsible for the clinical development of the Organon portfolio, including driving strategy, development for devices and lifecycle management. This leadership position will work collaboratively with colleagues in commercial, regulatory, statistics, clinical operations, CMC, project management, manufacturing and supply, and other partner groups to develop strategic plans across the portfolio. The person in this role is responsible for leading (or co-leading) and representing the scientific/clinical/medical perspectives at the development teams in the design, implementation and execution oversight and analysis of medical device development programs, life-cycle management (LCM) strategies, clinical studies, and post-approval studies. Clinical study implementation, execution and analysis will be in an outsourced operational model however, the person in this role provides medical oversight. This individual will be involved in interactions with Regulatory Agencies in support of development and LCM programs, as well as for labeling updates and other issues for in-line products. Other activities include the assessment of licensing candidates and participating in due diligence evaluations; providing scientific and strategic input into evaluations from early development through LCM.Primary Responsibilities: Responsible for the medical and clinical aspects of the strategy and development of the Organon WH product portfolio including strategy development, study design, execution, analysis, and communication of results of development and LCM trials/initiatives, in line with GCP, GPvP and relevant Organon SOPs Provides R&D leadership and oversight to a women's health medical device asset team and/or development and lifecycle team (DLT) with a focus on building a high functioning team Provides medical and clinical support to other functional areas within the organization involved in WH development and LCM programs Supports Clinical Operations group as needed for identification, management and executional and financial oversight of external vendors, including study-related CROs Partners with commercial regarding development and life cycle management opportunities for Organon WH products In line with the Organon governance structure, liaise with the senior management team for the approval of Development and LCM plans and studies Engages and communicates effectively with regulators, scientific leaders, and physicians, globally Provide scientific/medical/clinical strategic input to assessment of business development and licensing opportunities with a focus on medical devices, including preclinical through commercial stage opportunities, as needed Builds strong, large and globally dispersed teams which are highly productive and efficient Responsible for understanding global issues and helping stakeholders address them Responsible for leveraging internal and external networks to deliver on key priorities Helps Organon to develop talents and provides leadership and guidance to more junior members of ORD by sharing expertise and experience through mentoring, anizational Relationships:This position will report to the Vice President, Head Global Clinical Development within the Research and Development OrganizationResources Managed (budget and FTEs):This position manages other Clinical Directors and Clinical ScientistsEducation Requirement:MD or equivalent medical degreeMPH preferredRequired: Experience in Women's Health or related medical device development is strongly preferred At least 8 years of relevant job experience (medical devices / pharmaceutical / biotechnology) Experience and/or solid understanding of all levels of medical device development and also drug candidate clinical development (Phase I-IV) Must have experience with the planning and execution of strategies for drug product registration and commercialization / life-cycle management Demonstrated ability: to understand and manage, with appropriate support, the resources, time, and budgets for assigned projects; is business-savvy and results-oriented; to act as a subject matter expert and resource to others on effective project management techniques and concepts to obtain strategic alignment from key stakeholders around new initiatives and development of a shared vision for the organization; show strong team leadership skills in a matrix organization; excellent written and verbal communication skills; Proven ability to analyze, recommend, lead, and implement strategic, and process; At least 5 years of experience leading large and globally dispersed teams and in complex, cross-functional and global scenarios; Proven track record of managing global issues effectively and efficientlyWho 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.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Residents of Colorado: to request this role's pay range: email: 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.Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.Residents of Colorado: to request this role's pay range: email: coloradopayact@US and PR Residents OnlyIf you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency RuleOrganon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyOrganon 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.Employee Status:RegularRelocation:No relocationVISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Remote WorkShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID:R509077

Keywords: Organon & Co, Jersey City , Clinical OB/GYN Device Development Lead, Healthcare , Jersey City, New Jersey