Global VP of Medical

Position Summary:

The Vice President (VP) of Medical will be a key leader within the organization, responsible for overseeing the medical strategy and ensuring the highest standards of medical and scientific excellence. This individual will play a critical role in shaping the company’s medical direction, providing strategic input, and leading a team of medical professionals. The VP of Medical will collaborate closely with cross-functional teams to drive the development and commercialization of our products.

Key Responsibilities:

1. Global Medical Strategy and Leadership:

- Develop and execute the overall medical strategy in alignment with the company’s goals and objectives. Responsible for the successful clinical development of the Company's pipeline programs

- Provide medical and scientific leadership across all stages of product development, from clinical trials to post-marketing activities.

- Serve as a key medical spokesperson for the company, representing the organization at scientific conferences, advisory boards, and with key opinion leaders (KOLs) and potential pharmaceutical partners

- Develop a target product profile and development plan working closely with the global cross functional teams, executing clinical trials, coordinating with clinical research organizations and other vendors, developing and managing clinical advisory boards, broadening the internal clinical research capabilities, and overseeing all clinical collaboration

2. Global Clinical Development and Pharmacovigilance:

- Lead the medical team and oversee the design and implementation of clinical trials, ensuring they are conducted in accordance with regulatory requirements and ethical standards.

- Collaborate with the clinical development team to interpret clinical data and provide medical insights that inform decision-making.

- Stay abreast of the latest medical and scientific advancements, ensuring the company remains at the forefront of innovation.

- Drive execution of clinical trial plans to deliver compelling safety, pharmacokinetic, and efficacy data supportive of regulatory and marketing proof-of-relevance. -Guide the clinical team for site identification, enrollment and medical monitoring

- Lead the pharmacovigilance team to monitor safety in all clinical studies and oversee the clinical budget

- Act as a liaison for the Company with other pharmaceutical companies and partners to identify and implement collaborative studies

- Review study publications for scientific and medical content, and provide guidance on opportunities to jointly publish / present scientific and medical data in collaboration with partners and investigators

3. Regulatory and Compliance:

- Work closely with regulatory affairs to ensure compliance with all relevant regulations and guidelines.

- Provide medical input for regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs), CTA’s etc.

- Ensure that all medical activities adhere to industry standards and best practices.

4. Team Leadership and Development:

- Build, lead, and mentor a high-performing Medical team.

- Foster a culture of collaboration, innovation, and continuous improvement within the Medical function.

- Provide guidance and professional development opportunities for team members.

Qualifications:

- Medical Degree (MD) required; neurology therapeutic area is highly preferred.

- Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with a focus on Medical and clinical development.

- Prior experience in global clinical development of small molecule products or other modalities, ideally across all phases with emphasis on Phase 1 through Phase 3 clinical studies.

- Demonstrated capabilities leading clinical program(s) to successful regulatory filing and/or approval in both US and globally

- Prior experience in leading interactions with the regulatory authorities and knowledge of FDA/EMA/CDE and other GCP clinical requirements

- Proven track record of leadership in a senior medical role, with experience managing cross-functional teams.

- Strong understanding of the regulatory environment and experience with regulatory submissions.

- Excellent communication and presentation skills, with the ability to effectively convey complex medical and scientific information to diverse audiences.

- Demonstrated ability to build and maintain relationships with key stakeholders, including KOLs, regulatory agencies, and internal teams.

- Strategic thinker with the ability to translate medical and scientific insights into actionable business strategies.