Location: Greater Boston Area
Contact: Donna Gross, firstname.lastname@example.org
Clinical Medical Director - Rare Pediatric Disease | Clinical-Stage Biopharma Company | Greater Boston Area | RETAINED
This retained search is being conducted on behalf of our orphan disease clinical stage client. As the face of the program, this individual will be responsible for moving the programs forward quickly, making GO/NOGO decisions while utilizing in-depth clinical knowledge and expertise. This cross-functional leader will guide and direct the creation and execution of a development program for a portfolio compound or a group of compounds currently in clinical development.
We are looking for a creative, scientific problem solver who thrives in a lean, flat, energetic environment.
In this rewarding role you can make a tremendous impact as the development clinician, reporting directly to the Chief Medical Officer.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
Our client is a publicly traded clinical-stage biopharmaceutical company.
CEO with significant global, large organization, multiple function & therapeutic management experience.
Leadership team have multiple major successes over years of experience.
Opportunity to help shape the future of a small organization biotech with a big vision.
Location: Our client is located in the Boston, MA area.
HIGHLIGHTS OF RESPONSIBILITIES:
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions.
Serves on cross-functional Teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
Acts as liaison between Clinical Development and other internal groups for assigned studies.
DESIRED SKILLS AND QUALIFICATIONS:
MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate background in a clinical field).
Board certification/eligibility in gastrointestinal medicine is highly desired.
At least 3 - 5 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of scientific and clinical research methods and clinical study design.
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
Global clinical research experience and experience interacting with regulatory authorities is a plus.
Donna Gross, Director Life Sciences Recruiting
Phone: 267.483.5233 ext. 101
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976