Vaxxinity is seeking a Senior Medical Director, Neurology Clinical Development lead, who will play a key role in advancing the near-term Neurology pipeline targeting Alzheimer’s Disease, Parkinson's Disease & Migraine and contribute to future programs in various stages of preclinical development.
The successful candidate will lead and facilitate Clinical Development strategic planning and be responsible and accountable for the design and oversight of clinical studies and protocol development, implementation, medical monitoring, medical data review, results interpretation, reporting and regulatory submissions. In addition, they will, actively participate in development of biomarker strategies and lead innovation in trial design and endpoints. This role requires close collaboration with members of cross-functional teams, internal and external modality experts, and others in clinical development and beyond.
The position offers the opportunity to interact with multiple levels of management at Vaxxinity, peers and leaders from academic centers involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities.
- Immediately gain an understanding of our current clinical programs and maintain continuity of ongoing studies and Clinical Development Plans (CDPs).
- Monitor ongoing clinical safety and ensure compliance with FDA and any other relevant Regulatory Authorities.
- Lead Clinical Development Team and build mutually respectful relationships with colleagues. Trouble shoot challenges and provide direction, guidance, and support to the team to deliver on near term goals.
- Establish and forge relationships with key opinion leaders and partners, facilitate and support external collaborations.
- Lead and shape future clinical development strategy and CDPs, working closely with R&D Project Managers and counterparts in Regulatory, Clinical Operations, Statistics, Clinical Pharmacology, Preclinical Toxicology and Research.
- Assure CDPs are cutting edge, incorporate biomarker driven development strategy, include key decision points and timely readouts, and risk mitigation for both near and long-term goals.
- Design high quality clinical trial protocols for the lead compounds in development for Alzheimer’s disease and Parkinson's disease with a patient-centric focus, that are aligned with the CDP and product strategy.
- Contribute to the identification and development of biomarkers working with both internal and external experts as appropriate and lead implementation of the biomarker strategy in the clinical development program.
- Provide oversight of clinical studies, implementation, medical monitoring, medical data review, results interpretation, and reporting.
- Help build and manage the relationships with relevant CROs, facilitate excellent understanding and execution of studies, patient recruitment, and help assure trials are executed on time and within budget.
- Contribute to the regulatory strategy, preparation, and review of regulatory submissions, and participate in agency meetings as relevant.
- Provide strategic leadership to program teams and develop integrated product development plans, including scientific rationale, regulatory input and advice from medical and patient advocacy groups and payors.
- Contribute to the development of publication plans and present clinical data at key meetings and publish in high-level in journals.
- Contribute to Business Development activities as requested.
- Assure functional alignment and support the Chief Medical Officer in all related affairs as needed.
- The ideal candidate is a Neurologist scientist with a clinical perspective, coupled with a track record of achievement in clinical development, preferably in Neurodegeneration and/or migraine.
- MD PhD or MD with research training and or PhD credentials.
- At least eight 8 years of relevant experience within pharmaceutical/biotech industry.
- Working knowledge of basic and clinical science, broad understanding of Neurology disease areas, including familiarity with cognition and other non-motor symptoms.
- Demonstrated strategic and critical thinker, with success in designing clinical trials that have supported regulatory filings (experience designing and conducting phase 2 and 3 pivotal trials is advantageous).
- Established links with the medical community globally and locally, with proven ability to develop close working relationships with opinion leaders.
- Strong communication skills, professional presence, and ability to engage effectively with stakeholders at all levels.
- Collaborative and able to motivate and energize cross functional team members to achieve goals together.
- Strong problem-solving, and analytical skills, able to facilitate discussions among groups with diverse technical expertise, and progress decisions on complex issues.
- Able to lead both directly and by influence, is ego agnostic, reliable, honest and supportive of others, seeks to bring out the best in people, to resolve conflicts.
- High change agility with ability to operate effectively in ambiguous circumstances, open minded, with a can-do attitude.
- Excellent project management skills: self-motivated and can prioritize multiple tasks and goals to ensure the timely, on-target accomplishment of deliverables.