Medical Director - San Diego, United States - Candid Therapeutics

Candid Therapeutics

Verified Company

San Diego, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Company Overview:

Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients' lives by advancing novel therapies to address unmet medical needs.

Position Overview:

The Medical Director has responsibility for clinical development of our programs.

Responsibilities may include support for IND preparation, design and execution of Phase 1 to Phase 3 clinical trials, and medical monitoring.

This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of Candid Therapeutics' clinical development plan.

This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within the company's portfolio to ensure the program meets the needs of patients and the business.

Key Responsibilities:

Acquires and utilizes knowledge of clinical trial design to develop or oversee development of specific study concept synopses and protocols.
Participates or leads protocol review discussions concerning scientific and procedural aspects of study design.
In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance and supervision.
Contributes to the design, development, and review of CRFs, Data Management Manuals, and Data Analysis Plans
Addresses questions regarding scientific and related procedural issues from Investigators.
Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
Assists in the preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.
Supports priorities within functional area.
Anticipates moderately complex obstacles within a clinical study and, with guidance, implements solutions.
May be asked to coordinate teams and provide direction.
May lead specific components of departmental strategic initiatives.
Able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Manage, train, and mentor junior clinical science staff to support department and company goals
Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
Establish and maintain positive relationships with clinical trial investigators and thought leaders.

Qualifications:

MD or equivalent with 25 years experience in clinical research in academic, pharmaceutical/biotech, or CRO.
Deep commitment to understanding needs and improving the lives of patients and a passion for developing novel therapeutics.
Motivated to work in a fastpaced, high accountability, small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills.
Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
Demonstrated ability to collaborate successfully with multiple functions in a team environment.
Intellectually curious with courage to challenge and seek new ways to improve work.
Strong written and oral communication skills, including presentation skills.
Ability to analyze and interpret data and develop written reports and presentations of those data.
Strong critical, strategic, and analytical thinking skills.
Willing to travel as needed for the business.
Solid understanding of GCP and ICH guidelines.