Associate Director/Director, Clinical Development – NJ/PA

Employer
Ambrx, Inc.
Location
La Jolla, CA
Posted
Jul 02, 2021
Ref
27-20BA
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time

About Ambrx:

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into proteins, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, targeted immuno-oncology therapies, immunomodulatory smart cytokines, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

We are seeking a highly motivated Associate Director or Director of Clinical Development to be a key member of a fast-paced and dynamic organization.

Overall Responsibilities:

This position is a Clinical Development Leader who is a clinical development physician who plays a key role on the cross-functional drug development team. This role will lead and advance the clinical development programs, in various Oncology indications through early development to global regulatory submissions.

The level will depend on the experience.

Specific Responsibilities:

  • Lead Clinical Development Strategy and Planning and demonstrate ownership of study designs and hands-on implementation in support of the overall product development plan, based on strong cross functional collaboration, clinical and scientific principles, knowledge of compliance and regulatory requirements, markets and emerging issues
  • Responsible for hands-on implement clinical trials, protocol related documents development, clinical data review, and other study execution activities
  • Prepare and present research data, lead and participate in the discussion of the strategies in tumor types such as breast, gastric, prostate, bladder, RCC, NSCLC, ovary, biliary and pancreatic cancers.
  • Lead clinical study teams, monitor overall study integrity, and review, interpretation, and communication of efficacy and safety data
  • Present at scientific, clinical, and regulatory meetings globally
  • Develop and maintain relationships with academic investigators, pharmaceutical and/or biotech partners/sponsors, KOL’s, and patient advocacy groups
  • Contribute to regulatory filings including authoring clinical sections for INDs, BLAs, NDAs, and other related documents
  • Collaborate closely with relevant functions including statistics and data science, clinical operation, regulatory and quality assurance, clinical pharmacology, drug safety & pharmacovigilance, Pre-clinical, CMC and other cross-functional teams.
  • Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
  • Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
  • Establish strong working relationships and collaborations with study investigators, key opinion leaders in drug development, external partners, and CROs.

Qualifications:

  • MD required
  • Must have at least 6-15 years of experience as a high-performing hands-on physician with clinical development experience in conducting oncology clinical studies
  • Experience with ADCs (Antibody drug conjugates) is a plus
  • Must have a strong track record leading clinical trials efficiently and collaboratively with cross-functional teams, with excellent verbal and written communication skills
  • Must have outstanding presentation skills
  • Must maintain the highest level of data quality and integrity, to meet all relevant regulatory and health authority inspection requirements

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE