Senior Director

Senior Director, Medical Director Position Summary Reporting to the SVP, Head of Clinical Development, the Medical Director will lead a multi-disciplinary, multi-regional, matrix team. This individual is responsible for the development decisions needed to design, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. They will assist in guiding the strategy for global clinical development, taking into consideration the medical, scientific, regulatory and commercial issues for pipeline compounds, and by assessing and integrating the input from various functional areas. This individual will influence senior leadership decision-making, setting strategic direction for clinical programs. Responsibilities Provides clinical leadership for programs that integrate the individual's knowledge in basic science, drug development, and medical practice with input from the medical community around the world. Provides clinical content expertise to internal and external stakeholders Serves on one or more study management teams as a clinical development functional area leader, participating in all aspects of trial execution as required, including protocol design, reviewing plans and documentation, presenting at clinical study investigator meetings and other scientific and medical meetings, monitoring and reviewing incoming data, engaging with study investigators, and reviewing data outputs Provides ongoing clinical expertise and clinical oversight of clinical trials and serves as a medical monitor, partnering with external and internal stakeholders Supports conceptualization and conduct of clinical development strategies in conjunction with multiple functions and with consideration of how a given product will fit in with current treatments, standard of care, and unmet medical need. Integrates the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework in support of executing the Clinical Development Plan (CDP) Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling Authors, with colleagues, a variety of trial-related documents (e.g., investigator brochures, responses to regulatory authorities and institutional review boards, clinical study reports) Adheres to all requirements of good study conduct standards of Good Clinical Practice and other appropriate industry regulations Contributes to strategy and growth, and potentially participate in business and corporate development activities Flexes across Phases 1-3 and potentially across multiple disease areas as business needs evolve Requirements MD, MD/PhD, internationally recognized equivalent, 5+ years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned) Experience in development of therapies for rare disease required; neuromuscular and neurodegenerative disease preferred Must have experience with early phase development (Phase 1-3) Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions Superior communication, strategic, interpersonal and negotiating skills Ability to proactively predict issues, solve problems and drive decision-making within a multi-disciplinary, multi-regional, matrix teams, previous team management experience required Development experience beyond US/EU is desired IND/NDA/MAA Submission experience preferred Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred Diplomacy and positive influencing abilities across multinational business cultures Upon and if conditions permit, ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings; and ability to engage with multiple stakeholders virtually as required About PepGen PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen's Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit or follow PepGen on Twitter and LinkedIn. EEO Statement PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status. Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week. Recruitment & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.