Job Description

Job Description:

Our client is a rapidly growing biotech in the RNA medicines space with a robust clinical portfolio across Rare Diseases, Nephrology, Cardiology, Hematology and Ophthalmology. They are seeking an experienced, collaborative, strategic physician to build and realize the vision for the Company’s portfolio by helping build and execute clinical trial strategy. This is a leadership role that requires proven abilities to drive both strategic innovation and timely execution of clinical studies. The incumbent’s track record of clinical study expertise in both early and late-stage programs should be extensive. The incumbent will play a key role in the current and future business success of the Company.

Essential Responsibilities:

• Lead clinical plans, trial design, clinical trial execution, medical governance in the therapeutic areas.
• Serve as medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, business development and investor contacts.
• Develop and oversee project budgets ensuring quality, timely, on target and within budget of accomplished tasks.
• Other duties as assigned.

Clinical Leadership

• Lead team of empowered and motivated clinical staff, drive the vision and align the team to achieve success in developing assets in the therapeutic area.
• Provide leadership to the therapeutic areas. Build the best team and chart the course.
• Explore opportunities for improvement, ensuring that the therapeutic area is as effective and efficient as possible.

Clinical Trial Management

• Responsible for championing clinical excellence in the therapeutic area.
• Accountable for ethical conduct of studies in clinical trials.
• Define clinical strategies and priorities.
• Develop and oversee the development of clinical trial protocols and protocol amendments.
• Responsible for clinical study deliverables.

Regulatory & Safety Oversight

• Responsible for overall clinical trial outcome, working with Regulatory Affairs, Clinical Operations, Program management, CMC and other relevant departments and functions.
• Operate as a single point-of-contact for medical governance for the trials.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines and regulatory requirements throughout all phases of clinical research.
• Conduct investigator meetings and participate in site visits with Clinical trial investigators when needed.
• Draft and review regulatory documents and participate in meetings with regulatory authorities.
• Medical writing contributions and review of protocols and other critical study documents (e.g., Integrated Development Plan, Investigator Brochures, IND submissions, Clinical Study Reports etc.)

Cross-Functional Collaboration

• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Provide guidance and mentorship to team members, fostering a culture of excellence and continuous improvement.

Stakeholder Engagement

• Manage and maintain strong effective relationships with key external stakeholders and partners, key opinion leaders, investigators, consultants, and patient advocacy groups.

Essential Physical Characteristics:

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol:

Physical presence at the San Diego HQ is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Qualifications :

• Medical Degree (MD) and Board Certified.
• Minimum 5 years’ experience in leading clinical studies within the biotech/pharmaceutical industry.
• Minimum 4 years of leadership experience with excellent line management skills.
• Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.
• A proven track-record of leading clinical trials at all stages.
• Expertise in the areas of drug development, clinical operations and strategic planning.
• Expertise in scientific and clinical data review and interpretation, including in-depth analysis and presentation of data from strategic perspectives
• Expertise with SOPs, GCP, ICH guidelines, regulatory compliance requirements, and risk mitigation strategies.
• Some travel may be required.

Preferred Qualifications:

• Experience with FDA/EMA processes (IND filing, NDA filings).
• Experience in operations management within a clinical research setting.
• Strong leadership skills with the ability to work in a dynamic, fast-paced environment.
• Excellent organizational, written and verbal communication skills with effective presentation of complex scientific data to internal and external stakeholders are essential for this role.

Required Key Attributes:

• Strong understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
• Attention to detail while discriminating between critical and non-critical activities and to follow established processes.
• Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
• Strong problem-solving skills and a proactive attitude towards exploring new approaches.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.

Compensation:

• This is a full-time position, Monday-Friday, occasional overtime.
• Pay is commensurate with experience.
• Equity-based compensation
• Performance-based bonuses
• 401(k) with Company Match
• Medical, Dental, Vision
• Flexible Spending Account
• Life Insurance
• Employee Assistance Program
• Employee Discounts
• Gym Membership
• Paid Vacation
• Paid Holidays
• Paid Sick, Jury Duty, Bereavement

Work Authorization:

• United States (Required)

Job Tags

Similar Jobs