What are the responsibilities and job description for the Director/Sr. Director, Clinical Development position at Tbwa Chiat/Day Inc?
Director / Sr. Director, Clinical Development
About MLBio Solutions & BridgeBio Pharma
ML Bio Solutions (ML Bio), a BridgeBio company , is a biotechnology company founded in 2018, yet the company’s founders have been dedicated to finding a cure for Limb girdle muscular dystrophy type 2I / R9 FKRP-related (LGMD2I / LGMDR9) for close to twenty years. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30 drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
To learn more about our story and company culture, visit us at ML Bio Solutions | BridgeBio
ML Bio Solutions is searching for an experienced Medical Director to provide high-quality scientific and clinical knowledge to guide the strategy and execution of the BBP-418 clinical development plan, including the ongoing pivotal trial as well as future (including pediatric) trials. We are seeking an individual with solid critical, strategic, and analytical thinking skills who can communicate clearly and effectively in writing, oral discussion, and public presentation. Importantly, the individual should consistently demonstrate the capability of working collaboratively, prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail. The individual will contribute to and provide strategic direction to the cross-functional clinical teams and medical monitoring oversight for several ML Bio-sponsored clinical trials.
Responsibilities
- Act as a key contributor to BBP-418 clinical development, including execution, and medical monitoring of global clinical trials, including the ongoing pivotal program and launching future planned studies (including pediatric trials).
- Serve as the primary medical point of contact / medical monitor in responding to protocol-related inquiries, eligibility questions, safety issues, and other inquiries from investigative sites, CROs, CRAs, CRMs, and other matrix study team members.
- Perform ongoing medical review of clinical trial safety data - adverse events, serious adverse events, vitals, labs, protocol deviations, listings, and efficacy data – and respond as needed or in real-time as medical monitor and liaison.
- Collaborate with other members of the clinical team in the development and implementation of eCRFs, edit checks, coding, report development, and database lock processes.
- Develop and contribute to SOPs and guidelines to ensure proper study conduct and adherence to clinical study protocols.
- Monitor Study Performance and Quality Metrics in collaboration with Clinical Operations and Data Management.
- Contribute to the clinical research contributions sections of regulatory submission documents, including amendments to INDs, Briefing Documents, the medical and scientific content of regulatory correspondence, NDA / MAA submissions, safety reports and updates, and annual reports (DSUR / PSUR).
- Provide clinical interpretation and integration of pre-clinical and early clinical findings into the evolving product development plan and TPP.
- Design scientifically rigorous, operationally feasible, and cost-effective clinical study protocols as part of the broader BBP-418 Clinical Development Plan.
- Provide support to Clinical Operations in relevant aspects of study execution (e.g., patient recruitment).
- Take a leadership role in study team meetings and those with key internal and external partners, including presenting study updates, interim results, and final headline data to senior management.
- Be consistently patient-focused with a deep commitment to understanding the needs and improving the lives of patients through a passion for developing novel therapeutics.
- Be always motivated to work in a fast-paced, highly accountable, small company environment through a "can do" attitude as a collaborative, collegial professional who leads through influence and interpersonal skills.
- Demonstrate leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment.
- Lead the development of written reports and representations of the scientific program data toward the development of scientific publications and presentations.
No matter your role at BridgeBio, successful team members are :
Education, Experience & Skills Requirements
What We Offer
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
210,000 - $370,000 USD
Apply for this job
J-18808-Ljbffr
Salary : $210,000 - $370,000
