This is an exciting opportunity to join a biotech start-up company committed to developing innovative gene therapies for the treatment of rare and chronic diseases.
The Director of Medical is to be responsible for clinical development. Direct the creation of clinical development plan to translate the overall project strategy into an executable development plan.
The successful candidate will be involved with working on innovative and pioneering advanced therapies to treat rare and chronic diseases and benefit from working with cutting edge technologies and be the key player in the clinical development and advancing company’s innovative portfolio of products.
- Lead and/or contribute to designing, gaining approval of and executing high quality development strategy for rare and chronic diseases assets in US, collaborating with cross-function colleagues in the Frontera, key functional stakeholders and governance bodies, ensure local/regional/global clinical studies are adequately and timely supported and executed.
- Accountable for building an efficient and talented medical group; foster positive team culture and working environment; mentor and develop medical employees; streamline medical procedure, key quality indicator and key performance indicator.
- Accountable for leading medical input to clinical development projects from entry into development to successful approval. Lead a tailored medical team to plan and ensure the successful completion of development projects according to rigorous scientific and regulatory standards.
- Accountable for generating trial concept sheet, trial protocol, CSR; accountable for medical input to key regulatory documents, i.e., IND/CTA documents, IB, and NDA documents; accountable for scientific publications.
- Share local/regional clinical/scientific input during the development and execution of clinical trials.
- Contribute to providing medical and strategic oversight to the study execution, Monitor, analyze, and interpret clinical study data, participating in high level feasibility and project risk evaluation.
- Support the development and execution for clinical trials in the US and be the local/regional medical science expert in resolving significant issues that may affect the studies.
- Contribute to the preparation of documents required for regulatory submissions, Participate in interactions with regulatory agencies.
- Develop and interface with local/regional industry key opinion leaders and manage scientific presentation at advisory boards, key scientific meetings, and external committee meetings.
- Establish and maintain appropriate relationship with local/regional industry key opinion leaders and medical communities.
- Support business development activities as requested.
Required Education, Experience, Skills & Competencies
- Bachelor’s degree (advanced degree preferred) in a life science field (e.g., Medicine, Biology, Pharmaceutical sciences).
- Minimum 10 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company).
- Demonstrate in-depth knowledge in ophthalmic and/or Hematology and/or neuromuscular.
- In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
- Familiarity with concepts of clinical research and clinical trial design, including working knowledge of statistics as applied to clinical trial design and analysis.
- Previous experience in early and/or late-stage oncology clinical trials and regulatory filings.
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
- Experience in writing and editing scientific research reports.
- Thorough understanding of GCP and familiarity with relevant FDA and ICH guidance.
- Ability to collaborate effectively in and/or lead cross-functional teams.
- Strong commitment to goals and timelines.
- Ability to absorb new information quickly and gain command of relevant literature.
- Possessing excellent problem-solving & decision-making skills.