Job Description

Mantell Associates is currently partnered with a Life Science organisation in their search for an Associate Medical Director of Clinical Development

Associate Medical Director of Clinical Development - Responsibilities:

• To partner with the Head of Clinical development or Therapeutic Area Head in the development of clinical strategy for specific assets and their associated diseases
• To assist in the development or refinement of clinical development plans that are innovative, safe and create foundation for decision making and are aligned with therapeutic area disease
• Provide medical input and clinical strategy into the development of the Target Product Profile (TPP)
• Identify key external collaborations to further the overall development of the therapeutic area clinical development
• Provide guidance and expertise in the development of protocol synopsis and clinical trial protocol in partnership with clinical sciences
• Ensure that all safety and efficacy data acquisition is fit for purpose and registration ready (as appropriate)
• Perform medical monitoring duties as required (such as medical oversight of the study; answer questions about eligibility; review safety and adverse event data)
• Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones
• Play a key role in the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from safety and efficacy trials. Interpret data to produce strategically relevant abstracts, presentations and manuscripts
• Author (and/or work with medical writer to develop) other clinical documents like, briefing documents and other regulatory filings, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts
• Serve as medical representative with regulatory agencies
• Partner closely with research group leaders, drug discovery teams, bioanalytical and translational development teams, project and clinical operations teams
• Liaise with Clinical Operations to deliver therapeutic area clinical study program goals and milestones

Associate Medical Director of Clinical Development - Requirements:

• Excellent judgment and ability to resolve complex issues effectively
• Advanced medical degree (MD, MD PhD, PharmD), or equivalent
• Expertise in rare diseases/neuromuscular diseases/cardiovascular (regenerative/molecular genetic/gene therapy is a plus but not required)
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors
• Strong analytical mindset, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team
• Strong interpersonal and communication skills and experience in cultivating and managing critical relationships at all levels inside and outside of the organization.
• Exceptional attention to detail, organizational skills and judgment
• Adaptability and ability to shift with a changing biopharma landscape
• Superior verbal and written skills and ability to give well organized, thoughtful presentations to Solid management
• 5 years of clinical research or clinical development experience in pharmaceutical/biotechnological industry ideally across all phases of clinical trials
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy, design of study protocols, execution and analysis of clinical studies. Experience and familiarity with Good Clinical Practices (GCP)

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.

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