ACCELERON PHARMA INC Associate Director, Trial Master File Salary in the United States

Who are we?

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting newly approved REBLOZYL® (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States and are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes and myelofibrosis. Acceleron is also developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial and actively enrolling patients in the Phase 2 SPECTRA trial.

What’s in it for you?

The Associate Director of Trial Master Files (TMF) will be the individual accountable for building and providing leadership to the TMF group at Acceleron.

The TMF Associate Director will be responsible for ongoing planning, development and implementation of TMF SOPs, work processes and workflows. The TMF Associate Director will work with and train individual Clinical Study Teams to ensure the maintenance of inspection ready TMFs. Additionally, this highly motivated individual will establish quality control processes and metrics for internal and external TMFs, and be the primary TMF representative for inspections and audits.

What will you be doing?

• Build, lead, and provide oversight of the TMF group. Proactively identify resourcing needs, ensuring key roles are hired and onboarded to ensure clinical TMFs meet regulatory requirements and are inspection ready.
• Create and implement metrics/KPIs used to assess eTMF completeness and correctness; Ensures corrective actions for quality events/low performing metrics are implemented
• Oversee eTMF study creation, maintenance, and archival ensuring all activities are performed in accordance with Acceleron’s Standard Operating Procedures (SOPs), ICH-GCP Guidelines, EMA, FDA, and other health authority requirements.
• Participates in eTMF system assessments (new vendors, upgrades); Contributes to the specification, configuration, migration, UAT and implementation of the eTMF solution
• Responsible for developing and maintaining a Quality Control program by establishing control mechanisms for internally and externally managed TMF
• Manages and leads a team of document managers and document specialists (including vendors)
• In association with IT and other departments, manages the TMF technology provider(s)
• Supports regulatory requirements for TMF management and assesses impact to company's established processes; Contributes to risk evaluation and mitigation strategies
• Anticipates business needs to assess current state of eTMF and identify process improvement areas
• Participates in the process of CRO review and provide feedback in order to ensure the TMF processes comply with Acceleron standards
• Partner with CROs/Vendors to ensure responsibilities around eTMF are clearly defined and executed.
• eTMF representative for health authority inspections. Ensure inspectors have appropriate access to the eTMF prior to and during inspections.
• Functions as point of contact for eTMF questions
• Build and maintain strong partnership with cross-functional senior leaders to ensure eTMF completeness and correctness.
• Content owner for the eTMF SOP, Work Instructions and other associated documents.
• Assists with the identification of TMF business needs/requirements and translates them into software application and operational requirements using analytical skills
• Works with CRO partners and Third-Party Clinical Vendors on the continued development of TMF and Record Management practices and expectations

What are we looking for?

• Minimum of 7-10 years industry experience in management and maintenance of TMF/eTMF.
• Working knowledge of ICH-GCP, FDA, and EMA regulations.
• Considerable knowledge of the DIA TMF reference model.
• Previous experience managing and coaching direct reports.
• Strong vendor management skills; experience developing/implementing processes and performance indicators
• Strong written and verbal communication skills; effective collaboration, interpersonal and organizational skills
• Ability to resolve issues independently but escalating where necessary
• Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams.

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com