Director, Clinical Development and Medical Affairs

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Director of Clinical Development and Medical Affairs plays a key role in shaping and executing strategic and operational medical affairs initiatives. This includes engaging with internal and external stakeholders, contributing medical and scientific expertise to educational initiatives, and overseeing the development of clinical and scientific content. The role operates within a matrix environment, collaborating with health economics and outcomes research (HEOR), medical information, commercial, and market access teams to provide strategic medical insights that inform core brand strategies, support medical and marketing efforts, and enhance market access.

• Contributes medical and scientific expertise to strategy documents and project plans.

• Participates in design and execution of phase 2, phase 4 and registry studies, working with other internal stakeholders including clinical operations, statistics and regulatory.

• Provides scientific and technical support for assigned products as part of medical and promotional review committees.

• Delivers scientific presentations and supports US field medical team activities when necessary (eg training and education)

• Reviews and provides scientific/strategic input for medical information, HEOR and other medical communications.

• Supports global expansion plans, part of the scientific team interface for key regulatory discussions.

• Interacts with and coordinates appropriate scientific and medical activities with other internal stakeholders (i.e., commercial, clinical operations, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.

• Provides scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information.

• Provides input and assists in the development of scientifically accurate medical education, marketing materials.

• Supports the device innovation lead in prioritization and execution of device development.

• Work closely with the US field CS team in insight gathering, assessment and strategy evolution.

• Lead the US INO brand planning, execution in partnership with all INO sub-team functional leads.

• Work closely with ex-US colleagues regionally and functionally.

• Represent CDMA at congresses and engage scientific experts externally partnering with the field medical team and commercial.

• Partner closely with patient advocacy in highlighting patient and unmet needs.

• Steer the publication plan and strategy working closely with the publications team

• Develops content for and leads US advisory boards comprised of key opinion leaders. Assists with the scientific review, development, approval, execution, and communication of global medical affairs sponsored or supported clinical research activities.

• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.

• Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Collaborates with key opinion leaders (KOLs) and internal stakeholders to generate high quality publications.

• Typically, does not supervise employees but must be able to influence in a matrixed environment.

• Works mostly independently with limited guidance.

• Advanced degree required: PhD, PharmD, Medical degree (MD)

• Experience in nitric oxide therapeutic/scientific related area

• 8+ years of clinical trial or medical affairs experience in the pharmaceutical industry

• Ability to address complex problems within discipline/project or across disciplines.

• Knowledge of medical affairs, promotional guidelines and regulations

• Proven leadership skills in a cross-functional global team environment.

• Ability to interact externally and internally to support global business strategy.

• Ability to run a matrixed medical affairs team independently with little supervision.

• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.

• Ability to multi-task and work in a fast-paced environment and effectively collaborate in a dynamic environment.

• Experience with market access and reimbursement activities is preferred

This position reports to the VP, CDMA and will interact with internal colleagues in R&D, Commercial Operations, Compliance, Legal, Finance, HR and Business Operations. External collaboration includes trade associations, professional societies, payers, clinicians, policy thought leaders, and various government personnel and agencies. Collaboration across a matrix organization is required.

• Ability to travel up to 30% of time

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