For a Biotech company who is advancing an exciting pipeline of novel microbe-based therapeutic products and to further our efforts we are seeking a Medical Director who will support clinical and medical assets by the successful execution of clinical development programs and deliverables in partnership across the organization; with external academics and collaboration partners. The candidate will report directly to the CEO.
As a leader in the organization, the incumbent will be accountable to jointly develop clinical program strategy and assure that clinical activities are executed within expected scope, budget and timelines. The Medical Director will play a key role the establishment and growth of clinical research functions to assure best-in-class global capabilities and execution. This role will work closely with colleagues in clinical development, program leadership, clinical operations, regulatory, and translational research.
- Lead and oversee clinical strategy and activities to ensure project quality, timelines, and targets/milestones are met or exceed expectations.
- Integrate scientific rational, regulatory requirements, product development plan, and commercial goals to build solid clinical development plans and proposals. Establish clinical development timelines, incorporating key decision points and Go/No Go criteria for the clinical development plan.
- Responsible for on-budget and/or on-time study completion and compliance with all quality standards and applicable regulations from study start-up, enrollment, maintenance and close-out.
- Provide medical, strategic and pharmacovigilance leadership throughout conduction of clinical trials; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs.
- Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.
- Regularly liaises with the program lead and finance to develop, revise, and review study budgets. Act as the primary lead for the change order process with vendors.
- Facilitate generation of, author, update, and/or review key documents, including, but not limited to:
- Protocol concepts, synopses, protocols, and amendments
- Informed consent documents
- Investigator Brochures
- Statistical analysis plans
- Clinical study reports
- Patient narratives
- Abstracts, posters and manuscripts
- Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
- Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
- Risks / benefits analysis for applicable documents.
- Target Product Profiles
- Review, query, analyze and communicate clinical trial data.
- Provide scientific expertise for selection of investigator and vendors.
- Train colleagues and study site staff on the therapeutic area and/or clinical protocol.
- Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
- Represent the company as medical/scientific expert at conferences, symposia, and meetings with potential investors and business partners.
- Represent the company as a global medical/scientific spokesperson or key contributor with the internal and external community including regulatory and governmental agencies.
- Contribute to or perform therapeutic area/indication research and competitor analysis.
- Identify continuous process improvement opportunities.
- Identify incremental organizational resource needs – staff, budget, and systems.
- Develop, track, execute and report on goals and objectives.
- Be accountable for compliant business practices.
EDUCATION AND EXPERIENCE:
- MD, within a clinical and/ scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
- Minimum 3-5 years of clinical experience in early and late state projects and success within other biotech/pharmaceutical companies.
- Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical setting.
- Relevant experience in immunology and, inflammatory and autoimmune diseases; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills into the company’s autoimmune and inflammatory target indications.
- Expert understanding of global clinical study design and drug development process.
- High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
- Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
- Flexibility to work with colleagues in a global setting.
- Experience with the development and support of related SOPs and policies is expected.
- Knowledge of Good Clinical Practices (GCP), ICH, FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
DESIRED KEY COMPETENCIES:
- Executive presence; confident, positive attitude, enthusiastic and charismatic.
- Value based collaborator – respectful, accountable and collaborative.
- Strategic and creative thinker.
- Self-motivated and independently minded.
- Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Impactful written and verbal scientific communication.
- Successful and superior influencing skills across all levels of the organization and external collaborators.
- Problem solving and risk-mitigation skills.
- Appreciation of diversity and multiculturalism.
- Ability to build working relations throughout the organization and with business partners to achieve business goals.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
- Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.