As the VP Clinical Development for one of our major programs, 2109 for hypoparathyroidism,
reporting to the CMO, you'll help develop medicines for patients with endocrine diseases so
they can live fuller and healthier lives. Additionally, you will serve as Compound Delivery Team
(CDT) Leader providing leadership to a cross-functional strategic compound development team
and lead the development and execution of the compound strategy. You will champion the
product/brand at all levels of MBX and is responsible for managing the alignment on
communication on all CDT matters, as appropriate.
Key Responsibilities As Medical Director
- Lead the clinical development strategy of the compound including the path to registration and commercial success.
- Lead and supervise clinical trials, collaborating closely with the Clinical Operations team, be accountable for all deliverables of clinical trials under your direct responsibility
- Work cross-functionally to implement, manage, interpret, and communicate the results of clinical trials
- Be responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, ISSs, ISEs, clinical expert reports and Regulatory submissions globally.
- Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials
- Responsible for analysis of clinical data, including safety monitoring in collaboration with our pharmacovigilance partner
- Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and PIs
- Organize and present at relevant clinical advisory boards, DMCs and medical/scientific meetings
Key Responsibilities As CDTL
- Actively contribute to Compound Strategy decision-making by ensuring relevant research, analysis, and expertise is available.
- Lead CDT
- Partner with line functions to successfully develop the compound such that its
value is maximized over its lifecycle while costs and
- Build team effectiveness and lead the Compound Development Team (CDT)
to achieve its goals through the networks of people/functions represented on the team. When necessary, negotiate with function heads on functional deliverables.
- Challenge all functions on CDT to ensure that all issues and questions are being addressed, and that line function input into strategy and plans is adequate to meet the needs of the compound.
- Lead the development and maintenance of the compound development strategy in collaboration with the Project Manager (PM).
- Identify potential issues and lead contingency planning; lead CDT problem solving and apply decision-making tools and techniques. Drive CDT to make effective and efficient decisions.
- Accountable for overall budget and project plan deliverables.
- Build and maintain team effectiveness and satisfaction as well as drive
innovation by benchmarking
- Work with functional management to: Secure the required resources for
project success, influence optimal team composition, align goals and objectives with CDT members, coach and guide CDT members and provide input for performance evaluation of CDT members.
- Represent the program to LT and external community
- Establish and supervise external SAB
- Partner with discovery on life cycle extensions of 2109 and in identifying new
targets for metabolic bone disease
Education
MD, preferably with Board Certification in Endocrinology or comparable training, and recognized expert within his/her field. Bone research and development is highly preferred.
Experience
- 12+ years of relevant clinical research experience in industry
- Thorough understanding of Phase I-III drug development with proven ability to plan and
conduct clinical trials, deliver high quality results within established timelines, interpret, analyze, and communicate clinical/scientific data, and generate clinical/scientific documents
- Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions
- Knowledge of FDA/EMA requirements, good clinical practices, and pharmaceutical clinical development
- Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients
- Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
- Successfully worked in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities
- Embraces and models our core values—transparency, integrity, diversity and teamwork, innovation and scientific excellence
