Executive Director, Clinical Regulatory Affairs

Systimmune•Princeton, NJ

69d•$200,000 - $300,000

About The Position

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics. The primary area of focus is global regulatory aspects of preclinical and clinical areas of Oncology drug development and the policies/procedures required to ensure compliance with global HA regulations. The level for this role could range across Director/Sr. Director/Exec Director based on the demonstrated expertise, prior Oncology regulatory experience and global regulatory agency experiences (successful BLA/MAA filings) including label negotiations of the interested candidate. Prior experience of working across partner companies in a collaborative setting is highly desired. Leadership, temperament, and attention to details to drive data-informed decision making in a fast-paced setting along with the ability to toggle between “player/coach roles” as needed are strongly desired.

Requirements

Must possess excellent scientific/analytical thinking abilities, written and verbal communication skills along with an advanced degree such as Ph.D.
A minimum of 5 years of prior pharmaceutical industry experience (preferably in novel biologic/ADC based oncology drug development) at least 3 of which should include global regulatory strategy experience.

Nice To Haves

Prior experience of working across partner companies in a collaborative setting is highly desired.
Leadership, temperament, and attention to details to drive data-informed decision making in a fast-paced setting along with the ability to toggle between “player/coach roles” as needed are strongly desired.
A solution centric mindset with a drive to learn/grow, thrive in a fast-paced small company environment along with prior experience working in cross-company joint development collaboration settings would be highly desired.
Deep and comprehensive understanding of US FDA, ICH and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
Prior experience in working with collaborating sponsors across companies, geographic regions including China in novel oncology product development
High attention to detail; ability to coordinate and prioritize assigned projects according to corporate goals
Strong basic science/clinical/medical foundation and interpersonal skills both written and verbally

Responsibilities

Integrate scientific, medical and regulatory perspectives to drive development of innovative global regulatory strategies to achieve rapid approvals for investigational and marketing plans from agencies such as FDA, EMA, PMDA, NMPA (CHN)
Perform research to drive development of regulatory strategy for the assigned clinical development program
Lead and drive the preparation for Agency meetings and associated briefing document preparation
Lead and manage queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
Lead representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
Maintain knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
Exercise discretion, demonstrate integrity and independent judgment in the performance of the duties described above