The Role
Reporting to the SVP of Development, this role will drive clinical development strategies for therapeutic antibodies in neurological disorders including Huntington’s Disease, ALS and Fronto Temporal Dementia. The Medical Director will be pivotal in shaping clinical trial strategy and execution, serving as the Medical Lead for conducted trials.
Responsibilities
- Take charge of spearheading the development and execution of clinical plans for first-in-human clinical studies and beyond, taking into account Target Product Profiles.
- Developing ‘patient-centric’ trial concepts and overseeing their implementation at the program level ensures a balance of patient safety, quality, speed, and the need for results, as well as time and cost considerations.
- Leads and directs the formulation and operationalisation of clinical development strategies while ensuring compliance with regulatory and ethical standards.
- Has responsibility for study medical/ safety aspects and risk-benefit assessments supported by Pharmacovigilance specialists, including the development of Risk Management Plans.
- Collaborate closely with contract research organisations (CROs), clinical sites, and external vendors to oversee trial partners' selection, qualification, and management.
- Ensure that the team works closely with the wider Alchemab team and vendors.
- Oversees Clinical Study Report (CSR) medical content, meets high-quality expectations on medical standards, and provides respective guidance to other members of the clinical development team.
- Own and ensure preparation for clinical sections of key documents, such as Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
- Establish and nurtures relationships with key opinion leaders, industry partners, and other stakeholders to enhance the scientific credibility and impact of the trials.
- Communicates progress and findings to relevant stakeholders representing the team at decision/governance meetings, senior management, or advisory boards as necessary.
- Lead the way in innovating program and trial design while guiding and inspiring clinical teams.
- Engages in crucial business development and strategic planning activities, as well as contributing to activities shaping the future of indications and therapies at Alchemab.
Essential
- Extensive expertise in spearheading and overseeing clinical development initiatives within Neuroscience in biotech/pharma or academic environments, encompassing exploratory Phase I/II clinical trials.
- MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area.
- Has strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
- Having a solid understanding of the disease area is essential, along with the demonstrated ability to analyse, communicate, and present efficacy and safety data from clinical trials and the proven capacity to comprehend and interpret basic and clinical scientific research reports.
- Demonstrable experience in health authority interactions (EMA, FDA, CDE, MHRA).
- Direct trial experience with rare neurodegenerative disorders, including Huntington’s Disease.
- Familiar with US/EU regulatory requirements for clinical trials and drug development.
- Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modelling and biostatistics.
- Possess outstanding communication skills and a proven ability to influence at all levels, as well as experience in leadership and matrix management within a global organisation, leading horizontally, collaborating with other functions to execute workplans, prioritising tasks, and meeting strict deadlines.
- Demonstrated ability to establish effective scientific partnerships with key stakeholders.
- Experience with driving state of the art collaborations with external academic and industry partners.
- Demonstrated track record of successful project management in a scientific or clinical setting.
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
