Associate Scientific Director, Oncology/Hematology, North America

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:  Medical Director
Direct Reports:  None
Areas Managed:  North America

Overview

The Associate Scientific Director RRD North America (NA) is a key role in the delivery and support of many of the scientific activities required to support RRD’s Medical Strategy. They help interpret and communicate scientific topics ensuring that scientific integrity and medical insights guide all their activities. They are involved in the delivery of almost all aspects of externally facing medical communications and serve as a subject matter expert for other roles in Medical Affairs.

Essential Duties and Responsibilities

The Associate Scientific Director is directly responsible for delivering the following:
•    Contributing to the Medical Strategy, including Vision, Situation Analysis, Scientific Objectives, Key Messages and the related Tactical Plans.
•    Managing the planning, development and approval of deliverables intended to be used by RRD but not intended for publication in a scientific journal, including externally facing deliverables (i.e. scientific/medical education, treatment support, Standard Response Documents, etc.) or inwardly-facing deliverables (internal training, etc.).
•    Conducting the planning, staffing and reporting on scientific/medical congresses and meetings, including developing materials as required, attending the meeting, staffing booths, gathering insights and documenting outcomes.
•    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, 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.
•    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.

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The Associate Scientific Director also supports a range of other Clinical Development/Medical Affairs functions in their delivery efforts, including but not limited to:
•    Assisting in insights management by helping to evaluate and prioritize insights as well as capturing insights directly.
•    Supporting KOL engagement by field-facing personnel by supporting their planning efforts and responding to their questions.
•    Answering questions and providing resources to MA resources focused on payor engagement to ensure they have the scientific/medical information they need to be successful.
•    Serving as a scientific/medical subject matter expert to the Health Economics and Outcomes Research function.
•    Supporting publication development including assisting in outlining key publications, reviewing drafts and providing feedback.
•    Providing subject matter expert support to the pharmacovigilance processes as requested.
•    Serving as a subject matter expert in support of the medical review component of the promotional review committee as requested.
•    Assisting in the development of data analytics on RRD and external data sets, providing expertise and guidance to those responsible for developing the analytics. 
•    Supporting the clinical development function by providing scientific/medical subject matter expertise as that function navigates product strategy, protocol development, site management activities and study data analysis and communications. 

Education and Experience

•    Advanced scientific degree (M.D., D.O., Ph.D., Pharm.D.) in Medical, Biological Sciences required.
•    Strong scientific background with 5+ years of experience in Clinical Development and/or Medical Affairs preferred.
•    Experience with rare diseases preferred (including medical affairs, clinical practice, research).
•    Familiar with drug development process, FDA, ICH, and GCP guidelines.
•    Experience with medical legal regulatory (MLR) review 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 conflict resolution, collaborating 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; 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 average 3 days per week in the office expected.  
• The position requires domestic travel (up to 20%); 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 accommodation 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.