Executive Director/Distinguished Scientist, Business Development Safety

Job Description:

Organon 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!

Introduction

Organon is a new company with significant growth ambition, mainly in the area of woman's health. Business development is therefore a key activity to identify new products that could supplement the existing portfolio in all stages of the lifecycle. In business development evaluations of new product candidates, high stakes decisions are taken in a short time frame, often with limited amount of information. One of the key risks in BD projects is the emergence of safety concerns that have impact on the viability of the project or significantly influence the subsequent development and commercialization activity.

Position Purpose

The Business Development Safety Executive Director has a strategic role in de-risking BD activities so that the significant investment decisions are wisely taken, and the products will meet expectations for patient benefit and commercial yield. The BD Safety Executive Director is critical in evaluating available safety data to ensure effective safety decision-making in the assessment for individual assets, and synthesizing complex and voluminous data into concise but accurate summaries for team members without medical or research expertise. Their input will help prioritize business development opportunities based on both clinical benefit/risk assessment as well as evaluation of organizational cost, resource constraints, and impact to patients

Organizational Relationships

• Reports to the BD Safety TA Lead (AVP) under governance of Chief Safety Officer

Primary Responsibilities

The incumbent will be responsible for evaluating potential business development opportunities, with a focus on the clinical safety profile and potential risks of these assets. Appropriate assessments require ability to review clinical data, regulatory correspondence, and other background materials and provide a concise but thorough assessment. Responsibilities include:

• Synthesize all relevant data during due diligence to create robust assessment of benefit/risk including identification of key risks and mitigations

• Interact and communicate clearly with the cross functional BD team, including both BD members and other R&D representatives, to ensure that the company BD strategy is supported by a sound safety strategy

• Ensure that scientific assessments in BD are sound and holistic, with clear delineation of the benefit/risk balance or downstream impact on development and commercialization

• Influence the BD process so that safety strategy and Benefit/Risk assessment are integral part of every assessment step in the BD lifecycle

• Evaluate potential opportunities and prioritize based on an understanding of financial costs, impact, and overall budget limitations of the organization

• Translate complex medical or safety concepts into explanations easily understood by key stakeholders without medical or therapeutic area expertise

• Provide both written and verbal summary of safety findings to Executive stakeholders for go/no-go decisions

Qualification, Skills & Experience

Education:

• Required: MD, DO, or equivalent

• Preferred: Board Certification in Medical Specialty

Required:

• Clinical and drug development experience required

• In depth knowledge of clinical safety, pharmacovigilance and/or risk management

• Strong leadership skills, able to inspire and motivate colleagues to focus on business imperatives, work under pressure and achieve challenging business goals

• Self-confident and articulate, with excellent verbal and written communication skills, able to represent the company effectively in matters of patient safety externally

• Sensitive to diversity and inter-cultural differences, able to build effective collaborations across functional and geographic boundaries, lead change and promote learning and development for individuals and collectively

• Entrepreneurial spirit and desire to design, build, lead and execute new ideas and processes

• Excellent judgment in risk-assessed decision-making, with a strong problem-solving approach, solution- and results-orientated

• Communicates complex issues in an understandable, effective, and relevant manner

• Ability to build relationships, collaborate and influence across disciplines within Organon and with outside stakeholders

Preferred:

• Extensive experience in clinical development, drug safety or regulatory preferred.

• Specialty training or prior development experience in Women's Health

• Prior experience in business development

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.

NOTICE FOR INTERNAL APPLICANTS

In 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.

Add if Worksite is in CO or it is a fully remote role:

Residents of Colorado: to request this role's pay range: email: coloradopayact@organon.com

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.

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@organon.com

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

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OFCCP Pay Transparency Rule

Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R508518