Executive Director, Clinical Development - Nephrology (M.D.)

Position Summary (On-site)

The Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds. The Clinical Development Executive Medical Director will contribute to other activities such as regulatory submission activities, briefing books, etc. As a key contributor and medical leader of the cross-functional clinical team, the role leads medical strategy and supports ongoing clinical trial(s) end-to-end to achieve overall business objectives. This role will be a key contributor in building an integrated development plan and will provide support and expertise to new development activities, as well as clinical guidance and assessment of future opportunities to advance the science and address unmet needs in Clinical Development. The individual will be a self-starter with excellent clinical capabilities and who is seeking to be part of an innovative team that will drive early clinical development from first-in-human through proof-of-concept.

Key Responsibilities

• Provides clinical leadership, strategic input and medical and scientific review for all clinical deliverables in the assigned project or section of a clinical program if applicable, including regulatory documents. Clinical deliverables may include clinical sections of individual protocols or sub-studies consistent with the Clinical Development Plans (CDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.

• Drives execution of the section of the clinical program in partnership with other line functions (eg, Clinical Operations), and regional/country medical associates, if applicable.

• Medical Lead of the Clinical Trial Team(s) for ongoing and planned programs. Represents the section when needed in Senior management Team meetings, and as the section spokesperson in internal and external meetings/boards, as needed.

• Ensures compliance with GCP, SOPs, Business Practice Guidance and regulatory requirements as contributes to trial level budget plan and forecast being owner of and accountable for clinical work package.

• Ensures overall safety of the molecule, leading the Safety Management for the assigned compound.

• May lead / support interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups)

• Develop and execute the KOL engagement strategy, including establishing and management of a Scientific Advisory Board (if planned for the program), scientific exchange and externally facing medical activities (e.g., congresses, symposia, advisory boards, and speaker programs), ensuring scientific rigor, medical accuracy, and compliance with applicable policies and regulations.

• Establish and oversee the Investigator-Sponsored Trial (IST)/research grant program, including strategy, intake and review process, approval governance, budget oversight, and ongoing scientific/medical oversight in collaboration with cross-functional partners.

• Take a leadership role in proposed development to identify effective clinical and regulatory

implementation strategies that are efficient in time and money, and hedge risk as needed.

• Provide hands-on participation in the clinical program and trial development process; conceive and execute clinical strategy and contribute clinical expertise for research and development projects in highly competitive therapeutic areas.

• Assist in preparation of clinical sections of all relevant documents and regulatory filings (Investigator’s Brochures, INDs, and study reports)

• Assure implementation of latest scientific and clinical thinking as well as guidelines into the clinical development plans, including through interaction with key opinion leaders

• Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor and or medical monitor.

• Manage safety surveillance for assigned investigational compounds. Manage collection, in cooperation with a Pharmacovigilance vendor, of current data for safety signal detection and evaluation; identify and investigate safety signals; conduct analysis of safety data; and ensure adequacy of recording, summarizing, and handling of adverse events for investigational products, including decisions on seriousness, expectedness, and causality.

• Develop and maintain relationships with program counterparts in Pre-Clinical Safety, Research,

Regulatory, Clinical Operations, Clinical Pharmacology, Data Sciences, and Medical Affairs.

• Ensure the accurate and timely completion and reporting of periodic (i.e., DSURs ), expedited safety reports and investigator’s brochure in compliance with internal time frames and time frames dictated by regulatory authorities.

• Ensure the accurate and timely completion of updates to the Investigator’s Brochure.

• Attend and provide scientific support for investigator and consultant meetings and other study

implementation workshops

• Assist in the development of publications, abstracts, and presentations

• Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed

• Serve as medical resource for issues raised by internal and external collaborators, investigators, consultants and contract resources

• Manage outside consultants (consultants, etc.) to ensure data is accurately collected and analyzed in a cost-effective fashion

Qualifications

• MD degree required. Advanced knowledge and training in a medical/scientific area (e.g. Nephrology, Internal Medicine) Board eligibility required, with Medical Board certification preferred.

• 8 years of involvement in clinical research and drug development in industry environment. Involvement in clinical trials for kidney indications preferred.

• Early and late-stage drug clinical development and pharmacovigilance experience preferred, ideally 5 years’ experience of global clinical development, especially in EU and USA, contributing to all aspects of designing and conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry

• Must have experience designing successful clinical studies in complex diseases requiring the

management of patient variation. Must be facile with statistical issues and be able to manage working with a statistician to design the analysis of clinical studies.

• Experience in interactions with Health Authorities (e.g. FDA, EMEA, PMDA...)

• Demonstrated ability to establish strong scientific partnership with key stakeholders and work in a matrixed multifunctional environment

• Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development and pharmacovigilance process.

• Direct management of pharmacovigilance processes preferred

• Orphan Drug Designation experience preferred

Required Skills:

• Proven leadership experience and able to work both independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities.

• Must be analytical and articulate in both oral and in writing skills, with a demonstrated ability to

communicate well with others at varying professional levels, especially in the medical profession.

• Ability to write clinical study reports and summaries for regulatory purposes

• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public

• Ability to view issues from multiple functional perspectives while managing organizational ambiguity

• Proven ability to build relationships across key stakeholders

• Strong strategic, analytical, time and priority management abilities

• Proven expertise in cross-functional collaboration and teamwork

• Possess excellent written and oral communication skills

• Exhibits a drive for results, sense of urgency and solution-oriented approach