Senior Medical Director of Clinical Development
il y a 6 jours
Senior Medical Director of Clinical Development
BioTalent Ltd is seeking a highly qualified Senior Medical Director to join our team. 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.
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.
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