VP Clinical Development at Gilgamesh Pharmaceuticals
About the role
Company Description: Elevian is a well-funded, private, Boston-based, development-stage biopharma company developing new medicines that promote recovery after neuronal injury. Our lead program is a recombinant protein for the treatment of stroke in the days following the event, for which there are currently no viable treatments. Elevian’s lead therapeutic candidate is a regenerative circulating factor called recombinant GDF11 (rGDF11), which improves motor function recovery in preclinical models of ischemic and hemorrhagic stroke. Elevian is advancing rGDF11 to the clinic for post-stroke recovery, to transform the lives of patients and families dealing with this debilitating degenerative disease. The company’s laboratory and offices are in Newton, MA. Position Description: Elevian is seeking a VP Clinical Development, who will develop, lead, and drive Elevian’s clinical development programs. Key responsibilities will include providing strategic, design, and operational leadership for the company’s clinical programs. The VP Clinical Development will be involved in all aspects of the clinical programs, from design of first in human studies through to completion of Phase 3 registration studies and NDA filing. This role will work closely with internal functions and external partners/collaborators, Clinical Research Organizations, consultants and scientific advisors to manage the company’s clinical programs. The VP Clinical Development will serve as a key member of the Executive Management Committee and will also participate in strategic planning, partnering discussions and internal and external presentations. In this position, the leader will be expected to form effective, collaborative working relationships with others across multiple disciplines, attract and mentor key talent, and actively contribute to building Elevian's culture by exemplifying our core values. "Responsibilities • Provide strategic and operational leadership for all aspects of Elevian’s clinical development programs • Design and develop early development programs to transition from preclinical development to Phase II Proof of Concept studies and beyond • Lead clinical efforts to secure regulatory approvals • Collaborate effectively with internal R&D teams, consultants, CROs, consultants, and clinical/regulatory advisors to enable design, and execution of product development plans and strategies • Responsible for clinical sections in regulatory documents (e,g. IND submission, IND annual updates, briefing documents, study protocols, investigator brochures and other study-relevant documents like patient informed consent documents) • Work with clinical trial sites and investigators to drive enrollment and manage the clinical trials • Manage medical monitoring support to clinical investigators and internal/external team members • Manage safety activities for clinical studies"
"• Review and provide oversight of clinical trial data, external clinical data collection and clinical competitive intelligence • Ensure the company meets its clinical and regulatory milestones on time and within budget • Help to establish and maintain clinical collaborations with partners in academia, government, non-profit and/or industry • Play a key role in the portfolio review process to select, prioritize and accelerate the development of new indications and therapeutic assets • Attract and retain top-notch clinical and regulatory talent • Manage financial and human resources within budget • Demonstrate passion for the company’s mission and values and commitment to deliver results Required Experience • Advanced degree (MD or MD/PhD) in relevant discipline with experience in therapeutics • 7+ years clinical development experience • Significant record of accomplishment, including planning, designing and executing clinical studies • Thorough understanding of the drug development process and experience with clinical operations, medical affairs, biostatistics and pharmacovigilance • Working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical development • Demonstrated experience in clinical design and implementation of Phase 1 to Phase 2 Proof-of-Concept Clinical studies • Excellent interpersonal and communication skills • Ability to operate effectively within an entrepreneurial and science-driven company. A collaborative, confident, resourceful, energetic self-starter with the ability to take full charge and ownership of responsibilities and “roll up their sleeves” to do what it takes to complete tasks successfully • An effective leader who inspires trust and confidence with unquestionable integrity with the highest ethical standards • Experience with protein and/or antibody therapeutics • Early-stage development (FIH/Ph1, human PoC) Preferred Qualifications: ● Experience in stroke and other age-related diseases ● Experience in small to medium sized companies ● Experience with successful registration of therapeutics ● Experience with high value collaborations with academic and industry partners ● Understanding of novel trial designs, special designations, and global regulatory pathways ● Strong judgment and decision-making skills for critical decisions in conjunction with the R&D process and commercial planning ● Highly developed understanding of the marketplace and scientific literature to identify long-term benefits for patients’ unmet needs in age-related diseases"
Hiring manager- Contact Mark Allen @ Elevian
Why you should join Gilgamesh Pharmaceuticals
We are a startup developing exciting psychedelic-inspired drugs and companion biomarkers leveraging medicinal chemistry, neuroscience, and drug development functions. We are at the discovery stage but hope to get to a product pipeline in the next year. We are based in NYC but virtual.