Title: Medical Director, Clinical Development Location: United States time type Full time job requisition id R540924 Job Description The Position The Medical Director role works closely with the Executive Director, Clinical Development, and is responsible for protocol design and scientific oversight of clinical research studies involving new or marketed drugs. S/he will contribute to the clinical development and regulatory strategy for assigned assets, and will also be accountable for the design, execution, oversight, monitoring and report of clinical trials. This position reports into the Executive Director in the Global Clinical Development group within the Clinical Development and Operations organization. **This position can be remote within the US** Responsibilities Protocol design and study execution: - Lead or contribute to the development and updates to the global clinical development plan. - Work closely with Operations and vendor to identify and/or vet sites for clinical trial participation Design patient-centered clinical protocols that support strategic objectives, are feasibly conducted, and support efficient recruitment to meet program timelines. - Represent clinical development on study teams, collaborating closely with clinical operations and team members in identifying clinical study issues, barriers to execution, and developing sound strategic solutions with partners of the study team to ensure timely resolution. - Provide clinical input to clinical study teams for key documents, including informed consent, data review plans, medical monitoring plans, statistical analysis plans, clinical review forms, case report forms, data edit checks - Participate in design and conduct of Investigator Meetings for clinical trials - Monitor study conduct to ensure efficient recruitment, high quality of data and fidelity to protocol, and to minimize compliance and quality risks to enable a decisive readout. - In collaboration with biostats and safety, interpret efficacy and safety data from clinical trials and author CSR. Medical monitoring: - Directly monitor and provide oversight to CRO medical monitors, depending on the study execution model, to ensure patient safety and high-quality trial conduct. - Monitor study safety and provide input to safety narratives and reports. Regulatory Strategy and Submissions: - Collaborate with regulatory affairs on the clinical development and regulatory strategy to result in successful global submissions and approvals, integrating clinical, regulatory, market access and commercial considerations - Author and edit regulatory documents, including but not limited to briefing packages, response documents, and submission dossiers. External engagement: - Coauthor abstracts and publications and review IIS proposals as requested. - Build strong relationships with medical affairs and external thought leaders in supporting clinical development objectives. - Plan and execute advisory boards to support clinical development objectives. - Build strong relationships with patient advocacy groups to support patient-centered clinical development across all phases of development - Collaborate with medical affairs and commercial organization on life cycle management opportunities that generate value for the asset. - Participate in due diligence projects as requested to support assessment of external assets Requirements For Education, Experience & Skills - MD, DO, or MRCP - 2-4 years experience in clinical development in a biotech or pharma setting. - Relevant clinical experience in women’s health, dermatology, or pediatric development is preferred. Investigators with substantial clinical trial leadership or relevant research experience in an academic setting will also be considered. - Familiarity with ICH, GCP, clinical trial execution including medical monitoring processes. - Stays up to date with and uses relevant regulatory guidances, precedents, scientific literature and therapeutic landscape to anticipate risks and mitigations to clinical trial design and regulatory strategy. - Critically analyzes data quality and interpretation. - Collaborates with a one team mindset, fosters diverse perspectives, and leads matrixed team through complex decisions. - Functions with high level of independence. - Able to prioritize and deliver work, and adapt to changing corporate priorities, in a rapidly evolving environment. - Possess a high degree of integrity and personal ethics. - Strong written and oral communication skills. - Fluent in written and spoken English. - Travel may be required to support clinical trials or external engagement. #LI-Remote 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 For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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) $204,100.00 - $347,300.00 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: 1

Title: Medical Director - Rare Endocrine Disorders Location: Remote, US Job Description: Facility: Medical Affairs Location: Plainsboro, NJ, US About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference? The Position The Medical Director serves as the medical content lead for a Therapeutic Area (Diabetes-GLP-1, Diabetes-Insulins, Cardiorenal, Obesity, NASH, Rare Blood Disorders, and Rare Endocrine Diseases, Neurodegenerative Diseases). This role will interface with key stakeholders across CMR, Marketing, and the Global organization to support strategic development and execution within a therapeutic area. This includes the development of medical product and evidence generation plans based on insights from the marketplace. Responsibilities for this role will include leading the Core Medical Team, Project Team, and National Advisory Board meetings, serving as a key interface between the Global and NNI organizations. In addition, this role may represent NNI on Global Project Teams (GPT) and Commercial Access Teams (CAT) and provide detailed medical evaluation of assets under consideration for licensing and/or acquisition, when needed. Relationships This position reports directly to the Therapy Area (TA) Head, Medical Affairs and will assist in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. Key internal relationships include Project Managers, Field Directors, Medical Information, Publications, Clinical Directors, HEOR Directors, and Global Medical Directors. The Medical Director role will be with or without direct managerial responsibility within the therapeutic area, depending on business needs and at the discretion of TA Head for Medical Affairs. External relationships include expert advisory board members, investigators, other key opinion leader consultants, and key customer groups. Essential Functions - Lead the overall development of the Medical Product Plan, including medical strategies, tactics, and budget - Chair and drive cross-functional Core Medical Team (CMT) and Extended Medical Team (EMT) meetings - Gain endorsement of Medical Product Plan from Medical Affairs and overall CMR management - Align Medical Product Plan with Commercial colleagues - Partner with Project Manager to track key projects in Medical Product Plan and report on budget status - Provide cross-functional strategic direction and medical leadership - Lead planning and execution of National Advisory Board meetings - Secure approval for National Advisory Board meetings from Advisory Board Oversight Committee (ABOC) - Work with Project Manager to select and oversee vendor to ensure meeting logistics in compliance and meeting executed within budget - Partner with Global Medical Director to secure alignment with Global Advisory Board meetings, where appropriate - Drive development of agenda for advisory board meetings in collaboration with key stakeholders - Partner with key internal stakeholders to identify and select KOL advisors based on qualifications and business needs - Chair advisory board meetings/co-chair advisory board meetings with external KOL - Ensure meeting minutes and action plan developed and shared with relevant stakeholders within the organization - Drive Medical Affairs input to Evidence Generation Plan (EGP) and Product Development Plan (PDP) - Provide medical input to EGP and PDP as Medical Director representative on Project Teams - Co-chair and drive Project Teams for in-line and pipeline products in partnership with Clinical Director colleague - Secure line management input and alignment from TA Head of Medical Affairs - Present EGP and responses to PDP updates to NAO PDP Forum for endorsement - Develop trusting working relationships with Project Vice Presidents (PVP) relevant for therapeutic area - Present and share EGP with PVP and/or Global Project Team (GPT) - Member of Global Project Team (GPT) and/or Commercial Access Team (CAT), as needed - Represent NNI on therapeutic area relevant GPT and CAT (where seat available) - Coordinate and align NNI and Medical Affairs input to relevant issues - Share output, learnings, and relevant actions with NNI and Medical Affairs stakeholders where appropriate - Medical evaluation of emerging portfolio assets - Provide strategic medical evaluation of assets for licensing or merger and acquisition, at request of Senior Director, Pipeline & Market Development - Present findings and recommendations to NNI management - Other essential functions described in the Medical Director job document may also apply at times based on business need and at the discretion of the Executive Director Physical Requirements 20-30% overnight travel required. Position is Home Office Based; Ideal candidate can be based remote anywhere in the United States, ideally on the East Coast and near a major airport, yet able to travel to Plainsboro, NJ regularly. Qualifications - MD, DO, PhD, PharmD, or other relevant doctoral degree - A minimum of 10 years combined clinical, research and/or industry experience required - A minimum of 2 years of experience in the Medical Director role preferred - Research or pharmaceutical industry experience in the relevant therapeutic area preferred - Evidence of progressive leadership experience in industry preferred - Strong strategic mindset, agility, and problem-solving skills - Strong understanding of market needs and resource allocation - Expertise in clinical trial methodology and conduct, GCP principles, publications, ISS, medical education, and other medical product support activities - Superior communication skills, both oral and written - Proven track record of success, especially in establishing relationships with internal and external customers - The ability to work independently, the ability to proactively identify, address and resolve challenges, and to be considered a valuable resource who sets a leadership example for others The base compensation range for this position is $250,000 to $315,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

• The Associate Director, Medical has a deep understanding of the client’s business and demonstrates critical thinking and confidence • Provide strategic input to guide creation of clinically relevant educational content and ensure effective use of clinical data to reach strategic brand objectives • Independent scientific content development including analysis and interpretation of clinical data across a wide range of project types • Conduct literature searches, proactively monitor competitive landscape and perform competitive analyses • Establish strong relationships with clients and proactively seek to contribute and collaborate in client meetings • Partner with internal teams to create compelling peer-to-peer educational content and engagement projects for healthcare professionals • Establish close partnership with copy, art and digital teams to create interactive, engaging programs utilizing scientific storytelling techniques and unique data visualization • Collaborate to create and communicate Intouch’s POV and recommendations with clients • Play key role on team to educate team members on disease state, clinical trials, treatments and competition • Support submissions for client medical/regulatory approval processes

• Provide leadership, strategic direction, and management of an MSL team to support the company’s mission of advancing precision medicine • Ensure the team is adequately staffed, trained and clear on the expectations of their role in the execution of their medical plan • Develop and execute strategies to engage with key opinion leaders (KOLs), healthcare professionals, and other stakeholders within their area • Lead, mentor, and manage a team of MSLs to ensure effective communication and collaboration with healthcare professionals and KOLs • Develop and implement strategic plans to support the dissemination of scientific information and data related to Tempus’ products and services • Establish and maintain relationships with KOLs, healthcare professionals, and other stakeholders to support clinical and scientific objectives • Oversee the development and delivery of scientific presentations, publications, and other educational materials • Collaborate with cross-functional teams, including clinical development, marketing, and sales, to support product launches and other initiatives • Monitor and analyze industry trends, competitive intelligence, and scientific advancements to inform strategic planning • Ensure compliance with all regulatory and legal requirements in the dissemination of scientific information • Represent Tempus at scientific conferences, meetings, and other events