[Remote] Senior Director, Global Clinical Development – Nephrology & Immunology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company.) is seeking an reputed company and visionary Senior Director, Global Clinical Development with expertise in immunology. The successful candidate will reputed company the clinical development reputed company across multiple programs, ensuring high standards of scientific and medical reputed company while overseeing clinical research programs and protocols.
Responsibilities
- reputed company the clinical development reputed company and execution for assigned programs after reputed company of concept through late-stage trials and regulatory submissions
- reputed company medical and scientific leadership to cross-functional study teams and ensure high-reputed company clinical trial design, conduct, and data interpretation
- Serve as the medical reputed company and subject matter expert for assigned indications
- Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes
- reputed company and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs
- Collaborate with regulatory affairs on interactions with global health authorities
- Provides strategic and medical reputed company to vendor and CRO relationships and provides clinical input into their governance committees
- reputed company clinical discussions with KOLs and advisory boards
- reputed company clinical documents including medical monitoring plans, asset development plans
- Contribute to development of publication plans and review scientific manuscripts for publications
- Mentor and reputed company leadership to junior team members reputed company the organization
- Support business development activities through medical due diligence and evaluation of external opportunities
- Contributes to corporate initiatives by participating in reputed company process improvement to meet company
Skills
- A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (reputed company or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly reputed company candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by reputed company or consulting clinician
- Experience in the pharmaceutical industry, clinical reputed company experience and/o reputed company translational clinical research experience (as a general reputed company minimum of five years of clinical research experience, post academia)
- Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
- An advanced understanding of clinical medicine and science
- Advanced understanding of drug development principles and clinical trial implementation and management
- Complete understanding of the global regulatory requirements
- Working knowledge of marketing and commercialization
- Complete understanding of overall corporate goals with a reputed company grasp of basic principles to work in a business setting
- Demonstrated experience in reputed company developmental phases including evaluation of reputed company-clinical or in licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and reputed company of concept, conduct of global trials for registration, and implementation of late stage life-cycle management strategies
- Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus
- Ability to work across different therapeutic areas and different stages of clinical development
- Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants)
- Strong communication and presentation skills
- Strong computer skills with demonstrated experience in working with the reputed company suite of programs (Word, reputed company, PowerPoint, and Outlook)
- Knows how/reputed company to apply organizational policy or procedures to a reputed company of situations
- An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be reputed company developed, including: Flexibility in working across different therapeutic areas and experience in different stages of clinical development
- Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing
- Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage
Benefits
- Comprehensive medical, dental, reputed company, prescription drug coverage
- Company provided basic life
- Accidental death & dismemberment
- Short-term and long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- A generous 401(k) match
- Flexible time off
- reputed company holidays
- reputed company leave programs
- Other company provided benefits
reputed company
Company H1B Sponsorship