Early Clinical Development Director

Join our global team as Early Clinical Development Director.

Early Clinical Development (ECD) Director will develop integrated strategies for early phase clinical development trials, coordinate the development of multiple studies for biological and small molecule therapies for first in man, clinical pharmacology, bioequivalence studies, proof of mechanism, and proof of concept studies with patients and healthy volunteers and provide clinical, scientific and operational expertise by crafting the patient ecosystem ensuring the ECD strategy and portfolio.

This is remote, home based position for candidates from any EU country.

Responsibilities:

• Develop and implement the ECD strategy
• Create the strategy to protocol design/clinical development plan
• Create safe, innovative early phase study designs
• Support the study team and other stakeholders with medical, scientific and operational expertise
• Define the trial milestones, risks, analyze the gaps and develop improvement plans
• Analyze and define the needed internal/external resources
• Monitor and analyze the study related data, safety aspects, protocols for scientific/ regulatory compliance and feasibility
• Ensure and maintain awareness of industry pipeline, scientific and business landscape
• Participate in preparation of proposals for client’s and present in bid defense meetings
• Maintain business relations with relevant customers
• Manage safety monitoring of phase I-III clinical trials activity done by medical monitors
• Lead scientific activities, including publications and presentations
• Job description in more details is available upon your request

Requirements:

• 10+ years clinical research relevant experience, including hands-on operational delivery and/or early phase clinical drug development experience
• 3+ Experience in early clinical development and the conduct of clinical trials in patients and healthy volunteers
• Formal training in medicine and/or clinical pharmacology is a preference. Qualified and experienced candidates with PhD or other degree will be considered
• In-depth and current knowledge of scientific, clinical, regulatory and competitive landscape in clinical development (GCP, International Conference on Harmonization (ICH) guidelines and EMA or FDA guidance related to the conduct of First in human studies)
• Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization
• Flexible and able to work in volatile, uncertain, complex and ambiguous environment
• Strong business acumen, confidence with financial considerations, and comfort working in both sales and operational environments
• Excellent communication, presentation, influencing, negotiation, and interpersonal skills
• Confident and capable in the use of technology, applications and other media
• English language (both written and spoken)

Benefits of being a part of our team:

• Opportunity to make a significant difference to patients experiences and company development
• Opportunity to grow as a leader
• Supportive and respectful work environment
• Flexibility and quick decisions
• Bonus system, linked with achieved individual objectives
• Health insurance or covered related costs

 

Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs and Pharmacovigilance. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden, Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region.

 

Job Category: Clinical Research
Job Type: Full Time
Job Location: Europe

Apply for this position

Allowed Type(s): .pdf, .doc, .docx