Head of Drug Safety

tranScrip is a highly specialist pharmaceutical consultancy that, in the last 2 decades, has supported over 500 clients to deliver many development programmes and regulatory submissions.

tranScrip has an excellent reputation for providing strategic expertise, therapeutic experience and operational excellence across the entire product lifecycle, from translation to prescription.

The primary purpose of this role is to build tranScrip’s Drug Safety expertise needed for successful project delivery and to grow revenue opportunities with existing and new clients. This includes:

• Working with Business Development on expansion of existing, and acquisition of new clients
• Building/ maintaining, coaching and supervising a team of internal (employees) and external (contractors) SMEs to drive project delivery.
• Working with Project Management to ensure appropriate resourcing of their specific functional area expertise across the project portfolio.
• Overseeing that the work delivered meets the highest professional standards of quality.
• Enhancing the breadth and depth of client engagements and representing their specific functional area to internal and external audiences.
• Growth and development of Functional Line service offering.

MAIN DUTIES AND RESPONSIBILITIES

1) Functional Area Service Growth and Development:

• Promote externally tranScrip’s expertise as a leading specialist consultancy.
• Identify and attend relevant conferences and other industry events to represent tranScrip.
• Contribute to business development efforts by identifying opportunities for growth within existing and new client relationships and support proposal development.
• Contribute to pitches and proposals to secure new business.
• Contribute to account development plans to ensure repeat and expanded business.
• Act as a key point of contact for key clients to provide strategic insights and address issues
• Identify and build new service offerings within functional area.

2) Line Function Leadership and Oversight:

• Identify, recruit, onboard, and retain a team of top Subject Matter Experts, with complementary technical skills, experience and expertise in the specific functional area, consisting of both employees and subcontractors, to meet the evolving needs of tranScrip’s client project portfolio.
• Appropriately allocate and monitor resource utilisation across projects to efficiently deliver client projects to high quality.
• Organize appropriate review mechanisms to ensure outstanding technical quality of deliverables.
• Provide strong leadership and mentorship to a team of senior level Subject Matter Experts, ensuring their continuous professional development and performance.
• Conduct regular performance reviews, offering constructive feedback and identifying opportunities for growth.
• Foster a collaborative and inclusive team culture that promotes knowledge sharing, engagement, and accountability.
• Monitor industry trends and regulatory changes in the pharmaceutical sector to ensure the team’s expertise remains competitive and innovative.
• Contribute to a rigorous programme of CPD to ensure Line Function and industry knowledge is cutting edge

3) Subject Matter Expertise:

• Act as Subject Matter Expert on client projects, providing Line Function leadership for multi-functional projects, ranging from first in man studies to full clinical development, registration, and peri-launch/post-launch plans and or activities.

KEY ATTRIBUTES AND COMPETENCIES

• Higher level degree in Scientific, Medical or Commercial / Business discipline (e.g., MSc, PhD, Dip Pharm Med, MBA)
• Extensive drug development experience with a track record of progressing assets through translational, clinical or commercialization milestones
• Leadership experience within pharmaceutical, biotech or service industry; service industry experience or experience in consulting is advantageous
• Current working knowledge of GXP guidelines
• Strategic thinker, comfortable with being hands-on to get things done and with the ability to work in a fast-paced, dynamic environment, and with a healthy understanding of risk and reward
• Strong network of industry contacts, with a deep understanding of the pharmaceutical and biotech sectors and a demonstrated ability to build and maintain industry relationships
• Good level of general IT literacy including MS Office suite
• Outstanding communication, planning and organisational skills
• Flexible attitude to travel, working with an international client base and towards working individually as well as part of a team.