Director, Clinical Development Job Description Template
Our company is looking for a Director, Clinical Development to join our team.
Responsibilities:
- Development of clinical documents such as protocol/amendment update, IB update, annual study report, etc;
- Contribute to regulatory activities such as IND, NDA submission, and data cleaning activity;
- Clinical interface for other functions for successful delivery of study;
- Key role in analyzing the data, preparing clinical study report (CSR) and presenting to IDMC;
- Review SAE’s and safety data, ensure all relevant parties are notified and the company is compliant;
- Present the Medical and Clinical strategy to internal and external stakeholders, confidently relaying information to board of directors;
- Identify and qualify possible clinical trial sites;
- Build relationships to gain market advantage including thought leaders and principal investigators;
- Drive development of clinical strategy for products across pre clinical development, clinical research, manufacturing and regulatory affairs;
- Ensure all clinical trials are executed on budget and within strict timelines;
- Vendor management – Identify suitable vendors, delegate vendor responsibilities, develop vendor reporting procedures and plan of action;
- Reports directly to CMO;
- Develop protocols, investigator brochures and other relevant clinical documents;
- Ensure compliance to GCP, ICH and other ethical and company policy at all time;
- Review vendors performance on a monthly basis and ensure quality of work.
Requirements:
- MD (medical oncologist, or industry trained in oncology and/or immune-oncology or cell therapy);
- Experience in clinical trial oncology area for several years;
- Experience in Pharma industry for a number of years;
- Knowledgeable in science of oncology and able to analyze the data;
- Peptide based therapies advantageous;
- 3 years direct experience in drug development;
- NASH;
- Relevant MD;
- 5 years in a clinical setting;
- Excellent interpersonal skills, experience with leading and managing transversal teams;
- Ability to work in a diverse environment with different stakeholders;
- Experience with working according to GCP/ICH guidelines;
- Good command of oral and written English;
- Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities;
- Considerable degree of autonomy.