Medical Director, Clinical Development

Medical Director

The Medical Director role works closely with the Executive Director, Clinical Development, and is responsible for protocol design and scientific oversight of clinical research studies involving new or marketed drugs. S/he will contribute to the clinical development and regulatory strategy for assigned assets, and will also be accountable for the design, execution, oversight, monitoring and report of clinical trials. This position reports into the Executive Director in the Global Clinical Development group within the Clinical Development and Operations organization.

This position can be remote within the US

Responsibilities

Protocol design and study execution:

• Lead or contribute to the development and updates to the global clinical development plan.
• Work closely with Operations and vendor to identify and/or vet sites for clinical trial participation Design patient-centered clinical protocols that support strategic objectives, are feasibly conducted, and support efficient recruitment to meet program timelines.
• Represent clinical development on study teams, collaborating closely with clinical operations and team members in identifying clinical study issues, barriers to execution, and developing sound strategic solutions with partners of the study team to ensure timely resolution.
• Provide clinical input to clinical study teams for key documents, including informed consent, data review plans, medical monitoring plans, statistical analysis plans, clinical review forms, case report forms, data edit checks
• Participate in design and conduct of Investigator Meetings for clinical trials
• Monitor study conduct to ensure efficient recruitment, high quality of data and fidelity to protocol, and to minimize compliance and quality risks to enable a decisive readout.
• In collaboration with biostats and safety, interpret efficacy and safety data from clinical trials and author CSR.

Medical monitoring:

• Directly monitor and provide oversight to CRO medical monitors, depending on the study execution model, to ensure patient safety and high-quality trial conduct.
• Monitor study safety and provide input to safety narratives and reports.

Regulatory Strategy and Submissions:

• Collaborate with regulatory affairs on the clinical development and regulatory strategy to result in successful global submissions and approvals, integrating clinical, regulatory, market access and commercial considerations
• Author and edit regulatory documents, including but not limited to briefing packages, response documents, and submission dossiers.

External engagement:

• Coauthor abstracts and publications and review IIS proposals as requested.
• Build strong relationships with medical affairs and external thought leaders in supporting clinical development objectives.
• Plan and execute advisory boards to support clinical development objectives.
• Build strong relationships with patient advocacy groups to support patient-centered clinical development across all phases of development
• Collaborate with medical affairs and commercial organization on life cycle management opportunities that generate value for the asset.
• Participate in due diligence projects as requested to support assessment of external assets

Requirements For Education, Experience & Skills

• MD, DO, or MRCP
• 2-4 years experience in clinical development in a biotech or pharma setting.
• Relevant clinical experience in women's health, dermatology, or pediatric development is preferred. Investigators with substantial clinical trial leadership or relevant research experience in an academic setting will also be considered.
• Familiarity with ICH, GCP, clinical trial execution including medical monitoring processes.
• Stays up to date with and uses relevant regulatory guidances, precedents, scientific literature and therapeutic landscape to anticipate risks and mitigations to clinical trial design and regulatory strategy.
• Critically analyzes data quality and interpretation.
• Collaborates with a one team mindset, fosters diverse perspectives, and leads matrixed team through complex decisions.
• Functions with high level of independence.
• Able to prioritize and deliver work, and adapt to changing corporate priorities, in a rapidly evolving environment.
• Possess a high degree of integrity and personal ethics.
• Strong written and oral communication skills.
• Fluent in written and spoken English.
• Travel may be required to support clinical trials or external engagement.