Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growthThis is a high-profile and pivotal physician role with two core responsibilities:Project Physician: Provide medical and safety leadership for clinical trials within the field of immunology, ensuring robust design and execution of studies across early and late phases.Head of Safety and Pharmacovigilance: Oversee safety and pharmacovigilance across all clinical programs, ensuring ICH and GCP compliance. This includes leading the Clinical Safety Review Team and establishing robust processes to support the safety management of innovative therapies.The ideal candidate will be a highly experienced pharmaceutical/biotech physician with a strong background in medical monitoring, pharmacovigilance, and safety management. They will have a proven track record in preparing and maintaining regulatory documents. With exceptional interpersonal skills and clinical expertise, they will confidently collaborate with internal teams as well as an external network of site investigators and Data Safety Monitoring Boards (DSMBs).MAIN RESPONSIBILITIES:Medical OversightLead the medical and safety aspects of the design, implementation, and execution of clinical trials.Collaborate with site investigators to address clinical queries with expertise and confidence.Develop and refine clinical protocols, investigator brochures, and other essential trial documents.Ensure cross-functional alignment of clinical development plans with regulatory and commercial strategies.Stay at the forefront of immunology research and clinical practice to enhance the quality of clinical programs.Lead the Clinical Safety Review Team to monitor and safeguard patient safety.Regulatory and ComplianceServe as the clinical liaison, providing medical input into regulatory dossiers and communications with agencies (e.g., EMA, FDA) to facilitate approvals.Ensure compliance with GCP, ICH, and internal standards in all clinical activities.Cross-Functional CollaborationCollaborate with biomarker teams to integrate safety and efficacy data with pharmacodynamic and biomarker assessments.Work closely with R&D, translational science, and clinical operations to ensure alignment and support patient enrolment.Thought Leadership and External EngagementRepresent the company at scientific conferences, advisory boards, and industry forums.Build and maintain strong relationships with site investigators and DSMB members.Present clinical trial results at scientific meetings and publish findings in peer-reviewed journals.Team LeadershipMentor and develop a high-performing clinical team, fostering innovation and operational excellence.Collaborate with senior leadership to align clinical goals with corporate objectives.Act as a patient advocate within the organization, educating internal teams about patient and physician experiences to optimize clinical impact.QUALIFICATIONSEducation and ExperienceMD or MD/PhD, with a preference for additional training or experience in immunology or related fields.10+ years of clinical development experience, preferably within the biotech or pharmaceutical industry.Proven track record in designing and executing early and late-phase clinical trials.Expertise in pharmacovigilance, regulatory submissions, ICH/GCP compliance, and regulatory documentation.Skills and CompetenciesDeep understanding of regulatory requirements and clinical trial operations.Exceptional leadership, collaboration, and communication skills.Ability to thrive in a fast-paced, entrepreneurial environment.Demonstrated ability to build strong relationships with investigators and external stakeholders.While direct experience in immunology, cell therapy, or gene therapy is advantageous, the priority is placed on motivation and the ability to learn rapidly in this innovative field.Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.
Job Title
Senior Director, Clinical Development