Medical VP

I. Job Responsibilities

1. Clinical Development Strategy Formulation and Execution

   • Develop global clinical development strategies for the company's innovative drugs in non-oncology therapeutic areas (with priority given to neurology or pain-related fields).

   • Lead the design, execution, and review of summary reports for Phase I–III clinical trial protocols.

   • Responsible for the formulation, progress monitoring, and risk management of clinical development plans.

2. Regulatory Submissions and Communication

   • Lead the writing and review of medical documents for IND/NDA dual submissions in China and the U.S.

   • Represent the company in formal communications with the FDA and CDE (e.g., Pre-IND, EOP2, Pre-NDA meetings).

   • Ensure submission documents comply with relevant FDA, NMPA, and ICH regulatory requirements.

3. Team Building and Management

   • Build and manage the clinical medical team.

   • Set departmental goals, develop core talent, and establish cross-functional collaboration mechanisms.

   • Responsible for team performance evaluation and talent pipeline development.

4. Pipeline Strategic Decision-Making

   • Evaluate the medical value, risks, and commercialization prospects of pipeline projects.

   • Participate in "go/no-go" decisions and pipeline prioritization.

   • Assist in R&D project initiation or external licensing evaluation for new programs.

5. Academic Network and Medical Affairs

   • Build expert networks in non-oncology fields (with priority given to neurology or pain-related areas) and lead high-level academic exchanges.

   • Identify unmet clinical needs and collaborate with R&D to develop strategies that support innovative drug development.

   • Lead product medical strategy, literature updates, internal academic training, and external medical communications.

6. Pharmacovigilance and Compliance

   • Responsible for medical review of adverse drug reaction reports.

   • Ensure full lifecycle compliance with GCP, ICH-GCP, FDA 21 CFR Part 312, NMPA Good Clinical Practice, and other applicable regulations.

II. Qualifications

1. Medical Doctor (MD), with preference for internal medicine/neurology/pain medicine/anesthesiology or related specialties; 10+ years of clinical medical/clinical development experience in pharmaceutical companies.

2. Proven experience in the full process from Phase II to NDA for innovative drugs in non-oncology fields in China; led the design, execution, and NDA submission of at least 1 Phase III clinical trial for a non-oncology drug domestically; experience in neurology and pain-related fields preferred.

3. 5+ years of team management experience, having managed a clinical medical/clinical operations team of 10+ people; experience in building a team from 0 to 1 preferred.

4. Led IND dual submissions (China and U.S.) for both small-molecule and large-molecule innovative drugs; familiar with the full Phase I–III clinical development process.

5. Regulatory Familiarity: Proficient in FDA, NMPA, and ICH regulations; experience in direct communication with regulatory agencies.

6. Fluent in English: Capable of independently writing and reviewing English clinical protocols, investigator brochures, clinical study reports, and related documents.