Associate Director Project Management- CMC

Technical Operations San Francisco, California


Description

Basic Function:

The successful candidate will be key member of the CMC team and play an important role to help manage a cross functional effort to NDA/MAA filing. The individual in this role will collaborate closely with internal teams, consultants, marketing, regulatory, clinical, quality, development organizations, CMOs, and suppliers to lead this key function for the organization.

Essential job functions:

  • Guide the team through the development of the CMC global strategic plan that lays out a pathway for the successful development and approval of a new drug candidate.
  • Drive the development and manage the execution of high quality, integrated cross-functional plans.
  • Apply project management best practices in the development, initiation, planning, execution, control and closing of projects. Provide clear direction on project requirements to meet expectations of external customers and business stakeholders.
  • Proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate with the development team to develop appropriate solutions.
  • Facilitate cross-functional planning of CMC activities across departments and disciplines to align dependencies, schedules, and delivery commitments.
  • Support writing, review, publication, and filing of CMC related regulatory documents, including those associated with INDs, IMPDs, and NDAs.
  • Schedule, conduct, and draft minutes for internal CMC team meetings and ensure regular, efficient team, and stakeholder communication.
  • Assist in preparing presentations, dashboard, updating CMC project plans, etc. 

Desired Qualifications:

  • Degree in life sciences/engineering; Master’s degree preferred.
  • Strong understanding of the drug development process and working knowledge of the essential activities for all key functional areas.
  • Eight-plus years of cGMP development and manufacturing experience, including at least three years in a project management role.
  • In-depth knowledge of principles and practices of Project Management.
  • Significant experience across drug development stages from development candidate evaluation to late-stage development; phase III experience strongly preferred.
  • Strong leadership skills, including demonstrated ability to lead a cross-functional team, and influence at all levels of an organization.
  • Highly collaborative team player who fosters open communication and able to facilitate urgent needs.
  • Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Microsoft Project or Smartsheet, PowerPoint and Excel, etc.).
  • Excellent oral and written communication skills, including presentation and facilitation.
  • Ability to work independently and with flexibility to handle workflow in a fast-paced environment.
  • Some travel will be required, up to 25%.

Working Conditions: Will work from the Company’s San Francisco Bay Area office, with additional travel as required to oversee the virtual development and manufacturing network (estimated at 25%).

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more. 

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.