Director, Pharmaceutical Development
About The Position
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The Director of Pharmaceutical Development provides technical oversight of contract development and manufacturing organizations (CDMOs) supporting small-molecule programs from research through clinical development and eventual commercial production. Reporting to the Executive Director of Pharmaceutical Development, this role serves as a liaison for external manufacture of small-molecule drug products and collaborates with process development, analytical, formulation development, supply chain, quality assurance, and regulatory CMC colleagues to plan, coordinate, and execute development and manufacturing activities. The Director also leads drug-substance activities for one or more programs and manages projects independently. The position is based in San Diego, California. The ideal candidate is located in San Diego or is willing and able to travel there regularly. Up to 25% travel is required for internal meetings and collaboration in San Diego or South San Francisco, as well as external activities nationally and internationally.
Requirements
- 10 to 12 or more years of progressive experience in the biotechnology or pharmaceutical industry focused on small-molecule drug-product development and manufacturing.
- Experience managing relationships with contract manufacturing organizations.
- Knowledge of small-molecule drug-product validation and experience with regulatory submissions.
- Familiarity with ICH guidelines, regulatory expectations relevant to drug development, and cGMPs, including regulations in multiple countries.
- A strong track record of scientific achievement.
- Demonstrated ability to influence without direct control.
- Ability to build strong relationships with coworkers from varied backgrounds and areas of expertise.
- Ability to contribute effectively in a team setting as a manager, lead scientist, or individual contributor.
- Demonstrated ability to achieve performance goals and meet deadlines in a fast-paced environment.
- Effective interpersonal and communication skills, a collaborative approach, a can-do attitude, and the ability to identify and implement creative solutions to complex technical problems.
- Strong learning orientation, curiosity, and passion for science and patients.
Nice To Haves
- An advanced degree in Pharmaceutics, Chemistry, or a related field is highly preferred; equivalent work experience and scientific credibility may be considered.
- Experience with enabling technologies and solid oral dosage form manufacturing is preferred.
Responsibilities
- Provide scientific, technical, and strategic direction for the design, development, and manufacture of investigational drug products from preclinical and clinical stages through commercial production.
- Manage activities and contractual relationships with contract manufacturers and laboratories performing product and formulation development, manufacturing, analytical development and testing, stability, and validation services.
- Lead and collaborate with cross-functional project team members to meet CMC goals.
- Represent CMC drug-product activities and provide strategic recommendations and status reports to cross-functional program teams.
- Author, review, and/or approve development reports, regulatory submissions (including IND, IMPD, NDA, and MAA submissions), and SOPs.
- Serve as a subject matter expert on GMP regulations, ICH guidance, and current regulatory expectations for drug-product manufacture and process control.
- Lead drug-substance activities for one or more programs and manage projects independently.
- Perform duties in accordance with company core values, policies, and applicable regulations.
Benefits
- Annual bonus eligibility.
- Equity grant at hire and annually in the form of options to purchase company stock at a specified price.
- Paid time off, holiday leave, and sick leave.
- Medical, dental, and vision plans.
- Short- and long-term disability coverage.
- Basic and voluntary life and AD&D coverage.
- Flexible spending accounts, including FSA, HSA, and commute accounts.
- Critical illness and accident coverage.
- Pet insurance.
- Employee assistance program.
- 401(k) plan with an Erasca contribution.
- Opportunity to participate in an employee stock purchase program.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
