Position Summary:
The Executive Medical Director/ Vice President at Structure Therapeutics will provide program and medical leadership on clinical drug development of the assigned compound(s), including creating a clinical development strategy and plan, and all related activities. These activities may include, but are not limited to, study design and conduct, participation in key regulatory interactions as medical expert (IND and NDA), and being the medical lead to communicate with health authorities and medical societies during the drug development process.
Essential Duties and responsibilities:
- Maintain current scientific knowledge in relevant therapeutic areas and therapeutic mechanisms through review of scientific literature and attendance at relevant scientific meetings
- Lead development of global clinical strategy and clinical development plan for assigned projects.
- Provide medical leadership for the effective conduct of clinical trials, including:
- Collaboration with other functional areas to design clinical development plans and study protocols.
- Monitor and review medical data for clinical trials and represents the sponsor in Safety Review Committees.
- Engage with clinical investigators and study site personnel
- Analyze, present, and interpret data from clinical studies.
- Partner with Regulatory Affairs to ensure effective collaboration with global Health
Authorities, including:
- Preparation of clinical documents, or clinical sections of documents, as required
- Participation in updating key documentation (IB, DSUR, etc.)
- Represent Structure Tx in external engagement-related activities:
- Interact with external experts from health authorities and/or academic institutions (e.g., Scientific Advisory Committee, Key Opinion Leaders) as appropriate.
- Manage interactions with investigators to address scientific questions.
- Publish data in appropriate peer-reviewed platforms with abstract/poster, presentations, and manuscripts.
- Collaborate actively with cross functional teams, such as Pharmacovigilance, Regulatory Affairs, Clinical Operations, Data Management, Biostatistics etc.
- Evaluate opportunities and plans on assigned molecules for the development of new indications.
- Participate and support the research, in/out licensing of new targets or drugs in related areas led by business development and/or preclinical research team.
- Other duties as assigned.
Core Competencies, Knowledge, and Skill Requirements
- Deep knowledge of study design, protocol development and study conduct.
- Excellent written and oral communication skills in the negotiation, presentation, and authoring process with relevant cross function team, medical experts, as well as regulatory reviewers.
- Sufficient knowledge of business processes, regulatory, and compliance related to drug development.
- Travel requirements as needed.
Communication & Interpersonal Skills
- Excellent verbal and written communication skills.
- Ability to effectively collaborate in a dynamic environment.
- Competency in decision making, influencing, and execution in a changing business environment
- Comfortable with uncertainties through excellent risk management skill.
Qualifications:
Education
- A medical degree (MD or equivalent) with clinical experience in metabolic or related areas preferred.
Experience
- 7-9+ years of experience in clinical drug development in the pharmaceuticals/biotech industry, including designing and implementation of clinical projects in late stage (Phase 2b to Phase 3).
- Experience in preparation and submission of clinical trial and/or new drug applications.
- Managerial experience of a medical team preferred.
Travel Required:
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $345,000-$435,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
