We are currently searching for a skilled professional to join a well-known client's team as a Director, CMC Project Management in South San Francisco, California. The Director, CMC Project Management role will plan, manage, and drive the execution of CMC development and manufacturing activities for all clinical assets. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Partner with the Senior Vice President, Pharmaceutical Development and Manufacturing to plan and prioritize CMC activities across the clinical portfolio
Develop and maintain integrated CMC project plans and timelines for all clinical assets
Verify that plans incorporate cross-functional input
Lead CMC cross-functional and department team meetings to develop strategy and monitor progress
Create agendas and produces high-quality meeting minutes/related outputs to monitor program status
Communicate any changes in program strategy, issues, and/or risks to team members and other functional areas
Facilitate team discussion and agreements for concise program goals
Oversee deliverables to support program objectives
Identify risks and support the development of risk mitigation plans
Provide project management support for functional areas
Organize sub-team meetings and ad-hoc working groups to address specific topics
Collaborate with functional leads and finance to develop budgets for CMC activities
Interface with some vendors to ensure manufacturing activities stay on track
Update project status to senior leadership regularly
Contribute to or lead department and company initiatives for continuous improvement
Minimum of 10 years of relevant development experience in the pharmaceutical or biotech industry as a CMC functional area scientist and/or project manager, including 3 years managing cross-functional CMC or R&D project teams for multiple projects required
Strong understanding of the drug development process from a CMC perspective (drug substance development, formulation development, analytical, quality, regulatory, etc.)
Ability to manage multiple projects simultaneously and adjust workload based upon changing priorities
Excellent communication, interpersonal, collaboration, and negotiation skills
Minimum of Bachelor's Degree in engineering, physical, or life sciences required
Project management certification (PMP or equivalent) desired
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.