Senior Director, Clinical Development – Chronic Weight Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist Clinical Development in the area of Chronic Weight Management.

• Aid in the creation, implementation, and dissemination of the global scientific/medical evidence strategy.

• Facilitate cross-functional and global partnerships to incorporate extensive medical, scientific, and commercial insights into the development program.

• Foster the growth of significant scientific relationships with opinion leaders.

• Engage in and provide clinical insights during safety and regulatory discussions.

• Offer clinical/scientific expertise throughout the planning and execution of clinical trials.

• Analyze clinical trial outcomes.

• Participate in safety evaluations.

• Engage in communications with regulatory bodies.

• Draft Clinical Study Reports (CSRs), publications, and regulatory documentation.

• Cultivate relationships with key opinion leaders and deliver scientific presentations at advisory boards, significant scientific conferences, and external committee meetings as assigned by the Global Development Leader.

• Discover new clinical research opportunities.

• Assist in both in-licensing and out-licensing initiatives and maintain partner relationships.

• Support product lifecycle management for new indications as instructed by the Global Development Leader.

• Contribute clinical content to:

• Regulatory communications and documents.

• Safety communications and documents.

• Materials for Scientific Affairs.

• Materials for the Commercial Organization.

⛳️ Requirements

• MD or DO degree from an accredited medical institution.

• Five years of experience in clinical research and/or basic science research.

• Five years of managerial experience directly overseeing personnel and/or leadership experience guiding teams, projects, programs, or managing resource allocation.

• Over five years of combined clinical research experience and/or basic science research along with clinical teaching and patient care, especially in obesity, chronic weight management, and sleep apnea.

• Clinical research experience within the biopharmaceutical sector (biotech, pharmaceutical, or CRO company).

• Profound knowledge of the scientific method and clinical applications founded on medical, scientific, and practical rationale.

• Familiarity with clinical research concepts and clinical trial design, including biostatistics.

• Strong scientific and clinical judgment.

• Awareness of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, along with relevant international regulatory requirements.

• Capability to effectively articulate ideas and document complex medical/clinical concepts in both written and verbal formats.

• Proven track record as a medical expert in a multifaceted environment.

• History of addressing challenges while demonstrating excellent judgment and a balanced, realistic perspective on issues.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.