Associate Director, Product Development
Dova is a clinical-stage pharmaceutical company developing treatments for patients suffering from orphan diseases. The company’s lead investigational compound, avatrombopag, is in the process of completing two pivotal Phase 3 clinical trials researching its use as a potential treatment for thrombocytopenia in patients with chronic liver disease undergoing an elective procedure. For more information on the company visit www.dova.com.
Responsibilities will include, but are not limited to, the following:
This position will collaborate with colleagues in the company to assure successful, high-quality drug development. Candidates for this position should have a doctoral degree, and prior experience in industry is preferable. The position will require providing scientific contributions into the design, conduct, and assessment of clinical studies.
- Execute and supervise clinical studies, analyze results and write study reports.
- Contribute to the clinical sections of regulatory documents and meetings.
- Manage the drug development process from protocol creation thorough individual study report and integrated regulatory document creation.
- Collaborate with contributing groups such as Biostatistics, Drug Safety, Regulatory Affairs, Quality Assurance, Project Planning, and Clinical & Medical Affairs, etc.
- Collaborate with external contract service vendors, Investigators, and clinicians.
- A doctoral degree (PhD, PharmD, etc) is required.
- Three or more years of pharmaceutical industry drug development experience is preferable.
- Experience and expertise in creating and implementing drug development strategies resulting in efficient and successful product approvals.
- Expertise in the regulations and guidance (CFR, ICH, GCP) governing drug development.
- Expertise in the clinical drug development process is preferable. Effective leader of clinical research staff. Exceptional interpersonal skills. Ability to create highly functional, collaborative, and successful clinical teams.
- Expertise in assuring high-quality clinical trial conduct management, data management, and data analysis.
- A record of working effectively on clinical and cross-functional development teams.
- Expertise in problem solving for addressing clinical and conduct issues that may occur during study management.
- Comfortable working in a fast-paced, highly dynamic, and matrix pharmaceutical company.
- Excellent oral and written communication skills. Expert with Microsoft Office programs.
To apply please send CV and letter of interest to firstname.lastname@example.org