Sr. Director Clinical Development

Henlius USA Inc.; United States; On-site; USD 204,000 - 255,000; Full time

Job summary

Henlius USA Inc. is seeking a Senior Director of Clinical Development to lead clinical strategies for their innovative biopharmaceutical products. This role requires a Medical Degree and extensive experience in clinical studies, focusing on ethical conduct, strategic planning, and collaboration across departments. The ideal candidate will possess strong leadership skills and a proven track record in drug development.

Benefits

Medical insurance

Vision insurance

401(k)

Tuition assistance

Disability insurance

Qualifications

• 8+ years’ experience in leading clinical studies within the biotech/pharmaceutical industry.
• Minimum 5 years of leadership experience.
• Expertise in drug development and clinical operations.

Responsibilities

• Lead clinical plans, trial design, and execution for clinical trials.
• Serve as medical resource for clinical issues.
• Develop and oversee project budgets.

Skills

Leadership

Ethics

Communication

Strategic Planning

Clinical Operations

Education

Medical Degree (MD)

Job description

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Sr. Human Resources Manager Henlius USA, Inc.

About us:

Henlius is an international innovative biopharmaceutical company committed to providing affordable and high-quality biologics for patients around the world, covering oncology, autoimmune diseases, ophthalmic diseases and other fields, with 6 products approved for marketing in China, 4 products approved for marketing internationally, and 5 marketing applications accepted by the China Food and Drug Administration, the US FDA and the EU EMA respectively.

Senior Director Clinical Development

The Senior Director of Clinical Development will report to the Chief Medical Officer to lead the clinical development strategies to advance Henlius’ clinical stage product pipeline through regulatory approval. This position will lead various duties in support of all aspects of clinical development (science, medical, and collaborate with operations) for all assets/clinical protocols, leading the clinical/medical science team for trial level strategies, investigator/study site engagements trial activities, facilitating the communication of medical information, supporting the planning and preparation of scientific communications, and representing Henlius in investigator meetings, conferences and other forums.

Responsibilities:

• Serve as the Clinical Development Operations Lead for all clinical trials programs, provide clinical leadership and strategic medical input for all clinical deliverables.
• 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.
• Collaborate closely with Clinical Operations colleagues on clinical trial activities, specifically the management and oversight of global medical monitoring activities including oversight of CRO responsibilities and medical communications with clinical investigators
• 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 Associate Director Medical staff, drive the vision and align the team to achieve success in developing clinical trials in the therapeutic area.
• Provide leadership and build medical team in each respective therapeutic areas.
• 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 and accelerating patient recruitment efforts.
• 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 the leader for 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.

Qualifications:

• Medical Degree (MD) and Board Certified in Oncology.
• 8+ years’ experience in leading clinical studies within the biotech/pharmaceutical industry.
• Minimum 5 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:

• Preferred Thoracic Oncology experience
• 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.
• Mandarin speaking, reading and writing is a plus.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Tuition assistance

Disability insurance

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