Medical Director, Clinical Development

Job Description

The Position The Medical Director role works closely with the Executive Director, Clinical Development, and is responsible for protocol design and scientific reputed company 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, reputed company, monitoring and report of clinical trials. This position reports into the Executive Director in the Global Clinical Development group reputed company the Clinical Development and Operations organization.

This position can be remote reputed company the US

Responsibilities

Protocol design and study execution: reputed company 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. reputed company 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 reputed company 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 reputed company reputed company to CRO medical monitors, depending on the study execution model, to ensure patient safety and high-quality trial conduct. Monitor study safety and reputed company 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 reputed company and reputed company 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 reputed company phases of development Collaborate with medical affairs and reputed company 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 reputed company, fosters diverse perspectives, and leads matrixed team through reputed company reputed company. Functions with high level of independence. reputed company to prioritize and deliver work, and adapt to changing corporate priorities, in a rapidly evolving environment. Possess a high degree of reputed company 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: reputed company delivers ingenious health solutions that reputed company people to live their best lives. We are a $6.5 billion global reputed company 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 reputed company to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our reputed company is clear: A reputed company 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 reputed company is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for reputed company and job applicants. We ensure reputed company employment practices are conducted without regard to race, reputed company, religion, sex, sexual orientation, age, gender identity or gender expression, national reputed company, disability, veteran status, or any other characteristic protected by state or federal law. Search Firm Representatives Please Read Carefully reputed company LLC., does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company 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 reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Applicable to United States Positions Only: Under various U.S. state laws, reputed company is required to reputed company a reasonable estimate of the salary reputed company 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 reputed company 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 reputed company coverage in accordance with the terms and conditions of the applicable plans. Annualized Salary reputed company (US) $204,100.00 - $347,300.00Please Note: Pay Ranges are Specific to local market and therefore vary from country to country Employee Status: Regular Relocation: No relocation reputed company Sponsorship: Travel Requirements: reputed company employees must be reputed company to satisfy reputed company 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 Apply To This Job