Director of Clinical Development

Role Overview
The Director of Clinical Development reports to the Vice President and works closely with Clinical Operations and other departments to manage Requests for Proposals (RFPs) and support business growth.
The role is the main point of contact for clients throughout the pre-award process, from initial engagement through to contract closure. The Director participates in client meetings, capabilities presentations, bid defenses and face-to-face meetings, while providing strategic input from a Clinical Operations perspective.

Key Responsibilities
Client & Business Development

• Act as the main client contact throughout the client acquisition and pre-award process.
• Participate in client meetings, capabilities presentations, bid defense meetings and face-to-face meetings with Sponsors at all levels.
• Present relevant company services and develop sales materials in collaboration with relevant departments.
• Build and maintain relationships with current and prospective clients and business partners.
• Collaborate with Business Development Managers, Associates and the Business Development Director on new opportunities.
• Identify business opportunities with existing clients through upselling and cross-selling.
• Travel within assigned geographical areas to meet prospective clients.
• Ensure appropriate and timely client communication and follow-up through to contract closure.

RFP & Proposal Management

• Work closely with Clinical Operations and other departments throughout the RFP process.
• Participate in internal RFP calls, providing strategic Clinical Operations input and critically reviewing client documentation.
• Identify and prepare relevant questions to support proposal preparation.
• Work closely with the Proposal Writer, Clinical Operations Director and Medical Director to assess feasibility during the pre-award phase.
• Oversee the RFP process from a project management perspective, including:

• Preparing Gantt charts and timelines.Coordinating input from relevant functions.
• Contributing to slide development and delivery strategy.
• Monitoring deadlines and ensuring required inputs are provided.

• Contribute to and review RFP proposal content, providing comments and suggested edits where required.
• Support vendor selection by defining assumptions for quotations and critically reviewing quotations received to determine the most appropriate vendor.
• Support RFI preparation and manage data from the Experience Database.
• Participate in meetings focused on improving RFP conversion rates.

Planning, Quality & Performance

• Organise work independently, define priorities and manage workloads arising from unexpected events.
• Ensure KPI/KQI and other relevant activity metrics are achieved.
• Maintain accurate and timely records in the TRACK system.
• Complete all required training within the assigned deadlines.
• Ensure compliance with applicable rules, regulations, confidentiality and privacy requirements.
• Support quality-focused delivery in accordance with relevant guidelines and regulations.

Requirements

• Degree in a scientific field.
• At least 10 years of experience in a similar role within a CRO, biotech, pharmaceutical company, research institute or similar organisation, with specific experience in study management.
• Strategic mindset with the ability to support business growth.
• Strong negotiation skills.
• Excellent customer service and team leadership skills.
• Strong organisation, planning and budget management skills.
• Ability to prioritise and manage multiple high-value projects simultaneously in fast-paced environment.
• Strong project management and problem-solving skills.
• Strong commitment to quality.
• Strong understanding of ICH-GCP, ISO 14155, EMA, FDA and other relevant regulatory guidelines.
• Excellent English language skills.
• Proficiency in Microsoft Word, Excel and PowerPoint.

What we offer:
We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

At OPIS, you’ll join a collaborative international team where initiative and growth are encouraged.

Who we are:
Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.
 

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