Job Description

About the Client

We would like to introduce you a fresh new role for a Clinical Development Lead in progressive, smaller (but well-funded) Biotech, with their labs developing targets on their own ASO platform, and their own GMP.  The company is stable and has a long funding horizon in excess of 2 years + before milestone payments. The company’s leadership team is capable, ex Big Pharma and have a track record in developing, registering and launching new drugs.

About the role as a Clinical Development Lead

The role is graded as a Senior Medical Director, Clinical Development, reporting to the Vice President, Clinical Development and will be responsible for championing the product(s) under development. This includes the design, planning, execution, scientific integrity, and medical oversight of clinical studies for all phases of development for various therapeutic areas (TA) including neurology, pulmonology, hepatology, and potentially additional TA programs from early clinical development through regulatory approval. 

The successful person will collaborate with multidisciplinary functional representatives including Clinical Operations for study design and implementation, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program management, Preclinical Development and other functions to ensure aligned design and execution of all programs. You will serve as a core member of the clinical development team and will contribute to devising the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations.

Key Responsibilities:

• Provide input and strategic guidance to clinical protocol design, regulatory interactions and submissions, both translational and to pivotal
• Assess, coordinate and manage the communication with internal functions including Regulatory, Pharmacovigilance and Biometrics and external partners (CROs and consultants)
• Develop KOL engagement and conference strategies by using the counterparts in other functions and on own, and for CTs, supporting or driving investigator liaison and engagement, Kick Off meetings and presenting to Congress, Conferences and Symposia
• Engage and maintain relations with academic professionals, Health Care Providers and Key Opinion Leaders
• Collaborate and support the VP of Clinical Development on financial planning and budgeting
• Develop and implement SOPs for clinical trials
• Mentor and managing matrix and direct reports
• Ensure compliance with regulatory standards to clinical trials and physicians

Package & Location

Our client is based in Massachusetts, but they are offering a Hybrid working model with occasional travels to the office (2-4 days a month). They are offering a strong package depending on the experience of the individual. This role can be based in the UK or USA, so packages vary but are commensurate with the grade of a high-performing Senior Director.

To Apply

To apply for this role, please contact me, Christian or my senior colleague Matt on +1-908-332-9157 or send a full CV to Christian@AdvTalent.com and we will reply by return.

ADV Talent will help you each step of the way and know the stakeholders and line manager well and help you show you how to display your capabilities and strengths to your own benefit!