Senior Director, North America Field Medical Affairs - Endocrinology

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Chief Medical Officer
Direct Reports: Associate Regional Director, Field Medical Affairs, Endocrinology & MSL’s
Areas Managed: Medical AffairsInitiatives, Field medical activities

Overview

The Senior Director, North America Field Medical Affairs — Endocrinology will serve as our field-based scientific expert and leader, responsible for managing and guiding a national team of Associate Regional Directors and MSLs. This role's mission is to foster collaborative relationships with key opinion leaders, facilitate the exchange of unbiased scientific information between the medical community and the company, and drive strategic initiatives in the field of rare endocrinology. This role will leverage their clinical and medical affairs expertise to serve as a peer-to-peer liaison both internally and externally, ensuring the successful execution of the company’s medical strategies.

Essential Duties and Responsibilities

• Lead and manage a national team of Associate Regional Directors and their MSL teams, ensuring alignment with the company's strategic objectives in the field of rare endocrinology.
• Establish and drive the long-term vision and strategic roadmap for U.S. Field Medical in rare endocrinology, aligning medical activities with pipeline priorities, lifecycle management, and corporate growth objectives.
• Provides medical expertise and guidance for medical affairs. Ensures the MSL team has sufficient knowledge and information regarding the organization's products and therapeutic areas to be effective in the field.
• Support the development of scientific content for professional slide decks, medical letters, and clinical summaries, ensuring accuracy and consistency across the team.
• Shape the scientific communication platform for endocrinology, ensuring that field activities reinforce key scientific narratives and evidence generation priorities.
• Oversee the development and maintenance of relationships with national and regional KOLs in rare endocrinology.
• Lead the team in facilitating scientific exchange and collaboration with KOLs, ensuring that the company’s research and products are effectively communicated.
• Represent the company at key national and international medical conferences, leading the MSL team’s presence and activities.
• Provide strategic input into the planning and execution of Advisory Boards, collaborating with physician experts to guide content and discussions.
• Position the company as a thought leader in rare endocrinology through proactive engagement with academic societies, advocacy groups, and guideline committees.
• Ensure that all MSL activities comply with internal and external legal and regulatory guidelines, including pharmacovigilance responsibilities.
• Provides coordination and facilitation of MSL field research activities including assessment and selection of clinical investigators, site identification in relation to RRD clinical trials on marketed products, product line extensions, and products under development; as well as investigator sponsored studies. Supports presentation of final approved data.
• Lead the team in gathering and communicating clinical field insights, ensuring that critical information is shared with internal stakeholders through appropriate channels.
• Partner with R&D and Clinical Development to proactively identify unmet medical needs and shape evidence generation strategies (ISS, IITs, real-world evidence).

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External Engagement & Influence
•    Oversee the development and maintenance of relationships with national and regional KOLs in rare endocrinology.
•    Lead the team in facilitating scientific exchange and collaboration with KOLs, ensuring that the
company’s research and products are effectively communicated.
•    Represent the company at key national and international medical conferences, leading the MSL
team’s presence and activities.
•    Provide strategic input into the planning and execution of Advisory Boards, collaborating with physician experts to guide content and discussions.
•    Position the company as a thought leader in rare endocrinology through proactive engagement with academic societies, advocacy groups, and guideline committees.

Cross-Functional Collaboration
•    Collaborate with cross-functional teams to develop and execute a comprehensive medical strategy for rare endocrinology across the country.
•    Work closely with Clinical Development, Regulatory Affairs, and Commercial teams to ensure the alignment of medical activities with broader corporate strategies.
•    Provides guidance and leadership in the identification and management of internal and external materials in conjunction with the associate scientific director and director of MA, including the development and review of professional slide decks, medical letters, and clinical summaries.
•    Coordinates and assists with development and execution of medical training for the commercial team, for other cross-functional partners to include external and internal groups such as the clinical and safety teams, regulatory, and marketing in the related therapeutic area.
•    Act as a key resource for training internal teams, including sales, on relevant scientific and medical topics in rare endocrinology.
•    Ensure that field medical insights systematically inform clinical trial design, evidence generation planning, and lifecycle management decisions.

Compliance & Governance
•    Ensure that all MSL activities comply with internal and external legal and regulatory guidelines, including pharmacovigilance responsibilities.
•    Stay abreast of industry trends, clinical guidelines, and regulatory changes, ensuring that the MSL team remains compliant and informed.
•    Champion a culture of ethical engagement and compliance, setting governance standards for external interactions and field activities.

Evidence Generation & Research
•    Provides coordination and facilitation of MSL field research activities including assessment and selection of clinical investigators, site identification in relation to RRD clinical trials on marketed products, product line extensions, and products under development; as well as investigator sponsored studies. Supports presentation of final approved data.
•    Lead the team in gathering and communicating clinical field insights, ensuring that critical information is shared with internal stakeholders through appropriate channels.
•    Partner with R&D and Clinical Development to proactively identify unmet medical needs and shape evidence generation strategies (ISS, IITs, real-world evidence).

Education and Experience

• Advanced scientific degree (M.D., D.O., Ph.D., Pharm.D., NP, PA) in Medical Biological Sciences required.
• Minimum of 15+ of experience in Medical Affairs/clinical functions with progressive levels of responsibility, prefer at least 7 years as senior MSL and successful managerial experience.
• Familiarization with drug development process, FDA, ICH, and GCP guidelines.
• Experience leading teams-coaching, developing, managing etc.
• Experience with managing and executing medical affairs initiatives such as advisory boards and execution of scientific congress activities.

Knowledge and Skills

• Ability to review and interpret clinical data.
• Project management experience.
• Experience with rare diseases a plus (including Medical Affairs, clinical practice, research).
• Excellent time management and ability to work independently.
• Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint, Access including ability to run analyses using pivot tables.
• Familiar with GCP regulations and ICH Guidelines.
• Solid understanding of the principles of negotiation, influence and conflict management to assure effective interactions within and across departments.
• Demonstrated ability to manage multiple competing priorities.
• Solid organizational skills.
• A team player with positive attitude, enthusiastic energy and ability to have fun with team members.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier. This is largely a sedentary role; however the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

• This position is field-based, near major airport.
• The position requires extensive domestic travel (approximately 60%); occasional international
travel.

FLSA Classification

• This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodate for qualified individual with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

Disclosures: Annualized Pay Range (Base Pay): $238,000 - $278,000Other Types of Pay: Annual bonus Health Insurance: Medical, dental, orthodontia, vision, life & ADD, short and long term disability insurance benefits. Retirement Benefits: 401k Paid Time Off: Vacation, holiday, and sick/personal time.