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Clinical PM

Massachusetts, Waltham, 02451 Waltham USA

Vacancy expired!

About the Role: Cancer doesn't care how it disrupts the course of lives. We do. Since our founding, we have pursued one goal: develop targeted cancer therapies to improve outcomes for cancer patients. This singular focus has positioned us as a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer. At our company, each of us is driven by a shared conviction that by advancing precise, targeted cancer therapies, we have the power to offer more good days to patients and their families now. It is why we come to work each and every day, and it is what will continue to motivate and energize us in the years to come.

We are currently seeking a Contractor to join the Process & Analytical Development team within Technical Operations.

Responsibilities: Responsibilities include (but are not limited to) the following:
  • Manage our Critical Reagents program with an emphasis on creating and establishing an inventory management tool. This role provides critical support to the release and stability testing of our ADCs and antibodies.

  • Define a process in which interdepartmental personnel request and project critical reagent needs
  • Provide management oversight for Critical Reagent reference standards, analytical cell banks, in-house recombinant antigens, tagged antibodies and ADCs, small molecules, and other reagents critical to the release and stability testing of our assets. Critical Reagent Assets also include working closing with our clinical development groups for DMPK assays and toxicology studies.
  • Oversee reagent inventory and shelf-life management, planning resupply strategies through CROs or cross-departmental collaborations.
  • Work closely with collaborators across various R&D departments as well as partners and CROs commercial manufacturing organizations.
  • Provide Project Management support with CROs.
  • Effectively work in a matrix environment.

Life here We are looking for forward-thinking talent with diverse experiences and a track record of success, leadership skills, a demonstrated ability to take initiative, and a passion for improving the lives of those living with cancer. To succeed here is to care care about what we do, why we do it, and each other. We are working hard to bring hope to our patients and their families, which inspires our teams to aim high and honor our commitment to continuous improvement.

At our company, collaboration is not a construct. It is at the core of everything we do and shows up in how we work every day. Here, your ideas and experience matter. We value driven individuals who thrive in a fast-paced environment; who can think about our future and see the promise before us; who anticipate risks and opportunities; who are willing to learn and adapt to change; who are inclusive and eager.

Together, we rise to the challenge before us, advancing our programs on the strength of our deep scientific and commercial expertise and energized by the opportunity to change long-standing treatment paradigms. We pride ourselves on the work that we do and know that it is a privilege to work in the oncology space and to dedicate our days to helping patients.

Our Unique Opportunity It's an exciting time for our organization. We recently submitted our BLA under the accelerated approval pathway to the FDA for mirvetuximab soravtansine monotherapy in patients. This submission moves us one step closer to bringing more good days to ovarian cancer patients and transforming into a fully-integrated oncology company. This is just the beginning.

Joining us now will give you the unique opportunity to create a lasting impact to make your mark on the work that we are doing by leveraging your experience to shape our first commercial launch and the go-forward organization.

Basic Qualifications
  • Bachelor's degree in biology, biochemistry biotechnology, or chemistry.

  • Minimum of three years of industry experience, preferably in Biopharmaceutical or another large molecule environment.
  • Experience with quality control or cGMP laboratory working environments.

  • Process-oriented mindset
  • Demonstrated experience in maintaining meticulous documentation records
  • Inventory management and other logistical experience are highly desirable.
  • Excellent written and verbal communication skills, ability to interact with both internal and external parties
  • Excellent computer proficiency (MS Office - Word, Excel, and Outlook)
  • High detail orientation, organization, and proactivity.
  • Ability to work both independently and within a matrix team environment

  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
  • Strong project management experience with the ability to work on multiple projects simultaneously
  • Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
  • Ability to work independently and to carry out assignments to completion within parameters of instructions given prescribed routines, and standard accepted practices

COVID vaccine is strongly encouraged. Documentation of vaccine status may be required. Unvaccinated employees will be required to wear a mask.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real please visit

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