Associate Scientific Director, Oncology & Hematology (MD)

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, hematology 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:    Senior Director, Medical Affairs Hematology and Oncology, NA
Direct Reports:    None
Areas Managed:    North America (U.S. and Canada)

Overview

The Associate Scientific Director, Hematology and Oncology, NA (North America) is a key role in the delivery and support of many of the scientific activities required to support RRD’s Medical Strategy for the Hematology and Oncology franchise such as integrating Recordati’s scientific and clinical data into programs supporting medical affairs. They help interpret and communicate scientific topics, ensuring that scientific integrity and medical insights guide all their activities. They are involved in delivering almost all aspects of externally facing medical communications and serve as subject matter expert for other roles in medical affairs (MA).

Essential Duties and Responsibilities

The Associate Scientific Director is directly responsible for delivering the following:
•    Supporting Deliver through scientific lens the overarching Hematology and Oncology medical strategy such as providing input to the vision and scientific objectives which may include a situation analysis and key messaging, all of which contribute to the tactical plans for the Hematology and Oncology franchise.
•    Managing the planning, development, and approval of deliverables that include scientific/medical education, treatment support, Standard Response Documents, etc. or inwardly facing deliverables (internal training, etc.).
•    At the direction of the Senior Director, conducts the planning, staffing, and reporting on scientific/medical congresses and meetings, including developing materials as required, attending the meetings, staffing booths, gathering insights, and documenting outcomes.
 

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•    Managing RRD’s Investigator Sponsored Studies (ISS) process, including tracking received applications, managing the review process, tracking the contracting process and conducting ongoing communications with funded Principal Investigators (PIs).
•    Working with PIs that have completed their ISS to provide, at the PIs request, feedback on their outcomes communications and sharing those outcomes communications with the broader RRD organization.
•    Staffing the Medical Review Committee for the Hematology and Oncology franchise, including gathering deliverables required to be reviewed, distributing those deliverables to the reviewers, gathering feedback and/or approval of deliverables and following up on next steps for the reviewed deliverables.
•    Contributing to the Scientific Data Evolution plan development, including identifying data gaps that RRD needs to address to support its scientific objectives and key messages, determining potential approaches for resolving the data gaps and gaining alignment on the Scientific Data Evolution Plan.
•    Support evaluation of new business opportunities, including the development of business cases in close collaboration with the cross-functional partners, providing medical insights, including M&A opportunities and life cycle management activities.
•    Work collaboratively with clinical development and clinical operations on the design and execution of clinical trials in the Hematology and Oncology therapeutic area.
•    Contributing to regulatory filings and other regulatory-related activities as requested by the regulatory affairs function.
•    Developing scientific/medical training for both Medical Affairs and non-Medical Affairs staff, conducting that training and gathering feedback on opportunities to both improve future training and on new topics that may require training.
•    Provides scientific/medical subject matter expertise in support of cross-functional initiatives, including:
•    Responding to questions and supporting planning efforts for field-based medical affairs and payor engagement teams.
•    Contributing to insights management by helping evaluate, prioritize, and occasionally capture insights.
•    Advising on publication development, including input on outlines and review of draft materials.
•    Offering scientific input to pharmacovigilance processes, the promotional review committee, and health economics and outcomes research (HEOR) activities as needed.
•    Supporting data analytics efforts by offering subject matter guidance on internal and external datasets.
•    Providing scientific expertise to clinical development in areas such as protocol design, site strategy, data analysis, and communications.
 

Education and Experience

•    MD degree is required, with documented experience in Hematology and Oncology.
•    Experience in pediatric oncology strongly preferred.
•    Strong scientific background with at least five years of clinical experience is preferred.
•    Hematology/Oncology clinical trial experience is strongly preferred.
•    Pharmaceutical experience with a good knowledge of the applicable regulations is preferred.

Knowledge and Skills

•    Proficiency in Microsoft Office suite, basic computer and typing skills, and tools/systems for managing clinical trials.
•    Strong written and verbal English communication and presentation skills.
•    Skilled at with stakeholders with varying viewpoints, influencing with and without authority, and negotiation. Includes relationship management of multiple stakeholders, internally and externally, such as KOLs, networks, PAGs (Patient Association Groups), CROs and others.
 

Work Environment

This job operates in a professional office environment. Based upon job requirements, employee may be required at times to attend meetings including travel out of province 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 passport.

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 a commercial air carrier. This is largely a sedentary role when working in office; 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 located at RRD HQ Office in Bridgewater, New Jersey with 3 days per week in the office as minimum expected.
•    The position requires domestic travel (up to 30%); occasional international travel.
 

FLSA Classification

•    This position is considered Exempt.

EEO Statement

Recordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. 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, provincial, or municipal law. Recordati Rare Diseases will provide reasonable accommodations for qualified individuals 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.