Senior Director, Global Clinical Development – Nephrology & Immunology

About the role

The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).

Responsibilities

• Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
• Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
• Serve as the medical lead 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.
• Lead 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 oversight to vendor and CRO relationships and provides clinical input into their governance committees.
• Lead clinical discussions with KOLs and advisory boards.
• Develop clinical documents including medical monitoring plans, asset development plans.
• Contribute to development of publication plans and review scientific manuscripts for publications.
• Mentor and provide leadership to junior team members within the organization.
• Support business development activities through medical due diligence and evaluation of external opportunities.

Requirements

A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified 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 a team or consulting clinician.

Experience in the pharmaceutical industry, clinical practice experience and/or academic translational clinical research experience (as a general guideline 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 fundamental grasp of basic principles to work in a business setting. Demonstrated experience in all developmental phases including evaluation of pre-clinical or in licensing candidates’ potential for meeting an unmet medical need, establishing early clinical safety and proof 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 Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

Qualifications

A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified 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 a team or consulting clinician.

Experience in the pharmaceutical industry, clinical practice experience and/or academic translational clinical research experience (as a general guideline 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 fundamental grasp of basic principles to work in a business setting. Demonstrated experience in all developmental phases including evaluation of pre-clinical or in licensing candidates’ potential for meeting an unmet medical need, establishing early clinical safety and proof 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 Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

Skills

Deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. Complete understanding of the global regulatory requirements. Working knowledge of marketing and commercialization. Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting. Demonstrated experience in all developmental phases including evaluation of pre-clinical or in licensing candidates’ potential for meeting an unmet medical need, establishing early clinical safety and proof 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 Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

Benefits

Comprehensive medical, dental, vision, 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, paid holidays, and paid leave programs as well as other company provided benefits.

Pay

$249,973.00 - $388,125.00, plus incentive opportunity

Schedule

Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum.