Medical Director, Clinical Development

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 USResponsibilities 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 & SkillsMD, DO, or MRCP2-4 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 OnlyFor more information about personal rights under Equal Employment Opportunity, visit: EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementOFCCP 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

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