Job Summary
The Director, CMC Project Management will partner with the CMC Team Lead for one or more compounds, to plan and execute CMC goals supporting clinical development and commercial readiness. The candidate will also provide portfolio-level CMC project management and budget management support for the department.
Essential Duties and Responsibilities
- Manage CMC project teams consisting of representatives of various CMC line functions and as required for the projects (e.g., Process Chemistry, Drug Product Development, Analytical Sciences, Clinical Supply Chain, Regulatory CMC, Quality, etc.).
- Facilitate team meetings, in collaboration with the CMC Team Leader, develop meeting agendas, issue meeting minutes, and track action items to completion with cross-functional leads.
- Work with CMC teams to develop and optimize overall API, DP, and CTM timelines and project budget including resource planning (FTE, externals costs, outsourcing etc.).
- Ensure CMC functions are tracking to key deliverable and milestone timelines. Apply project management and technical expertise to monitor critical path timelines and resources.
- Inform CMC Team Lead of status, issues, problems, and proposed solutions and execute effective and timely communication to CMC line functions and management, and proactively communicate issues and concerns providing transparency with key stakeholders.
- Form sub-teams, as needed to resolve issues.
- Provide PM support, as needed, for management of critical vendors supporting the project, including participation in vendor management calls and review of vendor plans/timelines.
- Collaborate with CMC Lead, Finance and CMC line functions to assure that the team's financial needs are accounted for in the overall budget and are tracking against spend projections.
- Recommend and manage CMC authoring & review activities and timelines in support of regulatory files, coordinating with Regulatory CMC lead and CMC Lead.
- Coordinate conducting Lessons Learned initiatives for the CMC teams as appropriate, e.g. post-major regulatory filing.
- Demonstrate excellent leadership skills to tactfully influence individuals at all levels of the organization.
- On a portfolio level (all projects), coordinate best practices across all CMC PMs.
JOB QUALIFICATIONS
Education, Certifications, Experience
- BA/BS in a scientific or technical field. MS or PhD strongly preferred.
- Associate Director /Director expertise in at least one CMC functional area that directly contributes to successful drug.
- Minimum of 16+ years industry experience, with at least 4 years project/program management experience.
Knowledge, Skills and Abilities
- Able to analyze, summarize and present data to the stakeholders or decision makers.
- Demonstrated ability to work on multiple projects and meet timelines.
- Demonstrated ability to utilize project management tools successfully, e.g. Gantt charts.
- Strong written and verbal communication skills.
- Office environment / Domestic and International travel up to 25% may be necessary.
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
The expected salary range for this position is $195,000 to $215,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/
Vaccination Policy: Gossamer Bio is committed to complying with federal, state and local law on vaccinations. Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio ("Controller"), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing [email protected], because Controller wishes to evaluate your candidacy for employment at Controller.
Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller's Privacy team can be contacted at [email protected].
Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.
What We Do
Gossamer Bio is a San Diego-based company focused on the discovery and development of novel and differentiated therapeutic products, to address high unmet needs amongst various targeted patient populations. Founded by the former Receptos executive team, Gossamer Bio’s strategy will be to leverage an asset-rich in-licensing environment, with a focus on areas of high unmet need, utilizing a team with a strong track record of execution in immunology, inflammation, fibrosis and oncology.
