Sr. Director/VP Clinical Development and Medical Monitoring

Atom Therapeutics is a fast-growing innovative drug company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, has completed Phase 1 clinical trials in the US and demonstrated good pharmacokinetics and safety. A multicounty Phase 2 study with ABP-745 for treatment of acute gout flares is ongoing and a second multicounty study for ASCVD will be starting shortly. We are currently seeking a highly motivated leader to become part of our US clinical development team at Atom Therapeutics. This role will be based in the San Francisco Bay Area. Salary and benefits will be comparable with peers in the biotech industries in USA and China.
 

Job Title: Sr. Director/VP Clinical Development and Medical Monitoring

Department: Clinical Development

Reports To CEO

Base: Newark CA. In office work required.

Position Purpose:
This role will be a strategic leader possessing extensive experience in advancing clinical development and medical monitoring. With a strong medical and science background and an overall expertise in product value chain, the successful candidate should have a close collaboration with and an in-depth understanding of research and commercial functions. With awareness of external innovation competition, a candidate should be able to provide differentiation in clinical strategy to win the market.

Key Responsibilities

1. Leads clinical development strategies, including Phase I through III, life cycle management, safety responsibilities, and scientific interactions. Ensures that all clinical trials are in keeping with approved timelines and budgets.

2. Manage the day-to-day activities of the ongoing clinical studies and oversee and coordinate the work of clinical CROs.

3. Track and organize the clinical research developments and data analysis of relevant products that the company is monitoring.

4. Extensive experience dealing with FDA review experts, clinical KOLs, and physician experts. Good understanding of competitive market and unmet needs of the patient to deliver differentiated new products for treatment.

5. Manage clinical medicine, operations, registration, pharmacovigilance (PV), and data statistics-related matters. Organize and coordinate with various departments to ensure timely completion.

Education

• Doctor of Medicine degree

Experience:

• US Medical license 8+ years of direct experience in Pharma or Biotech with hands on experience in international new drug development. Very proficient in ICH guidelines and FDA requirements.

• 8+ years Director level or above in clinical development with Pharma or biotech.

• Experience working with development of inflammatory and cardiovascular drugs.

• Specific experience leading Phase I, II and III clinical trials on the global level,  including a strong experience in managing patient compliance during trials.

• Extensive experience dealing with FDA review experts, clinical KOLs, and physician experts. Good understanding of competitive market and unmet needs of the patient to deliver differentiated new products for treatment.

Skills:

• With broader view of the whole process, has in-depth understanding in the scientific field of early research which includes target screening, drug discovery, transfer medical and disease/therapeutic, clinical needs and clinic practices.

• Capable of providing differentiation in clinical strategy in the competition environment.

• Outstanding communication skills when internal facing with CEO and research and commercial team; and when external facing with investors, KOLs and CROs. Good people management skills are a must.  

• Strong in actions and know- how in the implementation and execution of responsibilities.

• Good knowledge and understanding of Statistics work.

Salary Range:

$250,000 to $375,000 per year, depending on qualifications and experience  

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Opportunity Employer