Clinical Development Medical Director
Proclinical is currently recruiting for a Senior/Executive Medical Director of Clinical Development with a biopharmaceutical company located in Philadelphia, PA. Successful candidate will provide input into the Company's clinical development strategy and lead the execution of the clinical development programs.
- Responsible for clinical trial activities for the Company's Development Plans including Istaroxime and Rostafuroxin.
- Formulate and develop operational objectives and provide input into the department's financial plan in support of clinical operations. This would include program leadership of specific development areas, preparation and execution of clinical protocols, and management of clinical sites, issues and responsibility for clinical timeline and budget management.
- Ensure compliance with GCP and regulatory guidelines.
- Recommend and implement innovative process ideas to impact clinical trials management.
- Serve as primary interface with clinical investigators and sites, and to identify resources, vendors and systems that are of the highest caliber available to facilitate the efficient operation of the clinical program.
- Collaborate with Manufacturing Operations to ensure clinical supply needs are met
- Ensure that appropriate actions are being taken to establish and promote quality and excellence in clinical trials.
- Operational and strategic oversight for the Company's pharmacovigilance activities including Serious Adverse Event reports, filing of annual safety reports and regulatory requirements with the Company's regulatory affairs group.
- Responsible for leading new indications and investigator initiated clinical studies
- Provide resources for training to staff, management, and clinical sites, and to provide prompt remedial training when and if it has been identified. Work closely with the department's clinical operations staff.
Skills and Requirements:
- MD degree required. Cardiologist preferred.
- 3-5+ years of experience in Clinical Development, Clinical Operations, or Medical Affairs.
- Significant experience with cardiovascular or inpatient drug development is a desired characteristic.
- Regulatory experience with US and other international regulatory authorities preferred.
- Strong interpersonal skills and ability to gain support and build consensus. Ability to listen to other points of view and respond appropriately.
- Experience working with opinion leaders and presenting at internal and external meetings.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call James Stevens at (+1) 646-693-0610 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.