Clinical Development Associate Director
A2 Biotherapeutics, United States
Job Description
At A2, our mission is to extend the reach of cell therapy to tackle the next frontier in cancer treatment: solid tumors. Our team is dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illness. Central to achieving this mission is our focus on recruiting the best talent and building an environment that enables our team to do the best work of their careers and make an impact on patients and society at large.
Reporting to the Head of Regulatory Affairs, and dotted line to the Head of Medical Affairs and Safety, this role is responsible for developing and shaping clinical, regulatory, and medical affairs communication documents, and the medical communications and information strategy to ensure successful execution of A2’s clinical development plan. In this role, you will have the opportunity to build the medical and regulatory communications capability at A2 as we advance our innovative pipeline of programs through the clinic. You will design and oversee content to ensure that scientifically robust messages and arguments are consistently conveyed across clinical, regulatory and medical documents, in line with regulatory and internal requirements. You will also be responsible for selecting and managing an outsourced writing team of vendors and/or contract medical writers. You will direct publication planning and be responsible for ensuring consistent clinical messaging and the timely review of clinical protocols, investigator brochures, investigator product manuals, manuscripts and all other clinical publications/presentations, as well as developing content for investigator meetings/advisory boards across all of A2’s clinical programs.
To be successful in this role, you must be able to lead effectively in a highly matrixed environment and oversee processes. Ideally, you will have an advanced degree in life sciences with a broad background that provides a solid knowledge of clinical drug development, oncology, medical communications and regulatory requirements.
This position can be remotely based (in the US) for the right candidate or located at our Agoura Hills, CA location.
Responsibilities:
- Establishes and builds the clinical, regulatory and medical communication capability at A2 including epidemiologic research for regulatory and clinical documents (e.g., by developing processes, tools and templates, resource model, internal expertise etc).
- Executes and influences successful delivery of A2’s regulatory strategy by providing regulatory-compliant documents with consistent messaging and use of program-specific technical terms resulting in well written, reader-friendly documents and applications.
- Directs and advises clinical and other cross-functional content owners on the development and delivery of regulatory, clinical and medical affairs documents in accordance with established timelines. Documents will include, but are not limited to: clinical protocols, investigator’s brochures, summary IND documents, regulatory agency briefing documents, response documents, and clinical study reports for our development programs.
- Partners with the Clinical Study Team to direct the development of high-quality study synopsis/protocols by ensuring all relevant (external and internal) stakeholders, partners are involved and contributing.
- Uses subject matter writing expertise to shape and direct A2’s Medical amp; Regulatory communications projects including preparation of abstracts, posters, presentations, whitepapers, manuscripts, publication plans, platforms for scientific communication, landscape analyses and gap analyses, or other materials for patients, clinical staff and physicians to ensure consistent messaging and alignment.
- Drives and influences decision making on data presentation strategies to support advance planning of documents. Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
- Communicates and collaborates externally with Investigators to author white papers, and review papers, protocols and peer reviewed publications, incorporating primary cell therapy data and epidemiological historical control data (eg, including documents to support orphan disease designations) with next generation sequencing.
- Collaborates cross-functionally with all key internal and external stakeholders to direct and shape publication strategy and content, and ensure alignment on key findings.
- Sources and engages contract regulatory/medical writers and/or vendors and oversees delivery of their projects for A2 (including planning, development, internal / external reviews, editing, quality control, and formatting of clinical regulatory and medical documents).
- Coaches, trains, and provides guidance to less experienced writers or contractors as A2’s Regulatory and Medical writing subject matter expert (