Senior Medical Director of Clinical Development

Remote based EU 

Position Overview:

We are seeking a highly qualified Senior Medical Director to join a progressive clinical-stage reproductive health company. The successful candidate will be responsible for providing strategic leadership and medical expertise in the design, execution, and interpretation of clinical trials, with a particular focus on women's health indications. They will play a pivotal role in shaping our clinical development strategy, driving the advancement of novel therapies.

Remote based in Europe, with travel.

Key Responsibilities:

• Clinical Development Strategy: Develop and implement comprehensive clinical development plans for early phase trials in women's health indications, aligning with company objectives and regulatory requirements.
• Study Design and Protocol Development: Lead the design and development of clinical trial protocols, ensuring scientific rigor, ethical standards, and alignment with regulatory guidelines.
• Medical Oversight: Provide medical oversight and guidance throughout the lifecycle of clinical trials, including medical monitoring and support to safety surveillance.
• Cross-functional Collaboration: Collaborate closely with cross-functional teams, including clinical discovery / translational science, regulatory affairs, pharmacovigilance, and biostatistics to ensure seamless execution of clinical programs.
• Regulatory Interactions: Serve as a medical expert in interactions with regulatory agencies, including FDA, EMA, and others, providing clinical input and support for regulatory submissions.
• Data Analysis and Interpretation: Analyse clinical trial data, interpret results, and contribute to the preparation of study reports, publications, and presentations for internal and external stakeholders.
• KOL Engagement: Build and maintain relationships with key opinion leaders (KOLs), investigators, and academic institutions to stay abreast of scientific advancements and emerging trends in women's health.
• Negotiations: Support the executive team in interactions with stakeholders, investors and fundraising.
• Risk Management: Identify and mitigate clinical development risks, proactively addressing issues and ensuring compliance with regulatory requirements and industry standards.
• Team Leadership and Mentoring: Provide leadership, guidance, and mentorship to junior medical and clinical development team members, fostering a culture of scientific excellence and professional growth

Qualifications:

• Medical Doctor (MD) degree with board certification in a relevant therapeutic area (e.g., Obstetrics/Gynaecology, Internal Medicine, including, e.g., reproductive medicine, menopause, contraception, or gynaecological oncology, etc.).
• Substantial experience in clinical development within the pharmaceutical or biotechnology industry, with a focus on early phase trials and women's health.
• Proven track-record of authoring key technical and clinical documents, including but not limited to clinical study protocols, clinical study reports, investigator’s brochures, annual reports, and clinical sections of regulatory submissions.
• Experience managing CROs, central laboratories, and other clinical study vendors
• Act as medical monitor to clinical trial(s)
• Proven track record of successful leadership and management of clinical development programs.
• Strong understanding of clinical trial methodology, GCP guidelines, and regulatory requirements governing drug development in the EU and US.
• Excellent communication skills, with the ability to effectively collaborate with internal and external stakeholders, including KOLs, investigators, and regulatory agencies (including attending FDA/EMA meetings).
• Demonstrated strategic thinking, problem-solving ability, and decision-making skills in a fast-paced, dynamic environment.
• Be able to provide clinical input to study teams on Case Report Form design, statistical analysis plans, monitoring guidelines, Data Review Plans, and Quality Management Plans as needed