Director, Clinical Development - Early Development Team Leader
Jersey City, NJ
We are currently searching for a skilled professional to join a well-known client’s team as Director, Clinical Development – Early Development Team Leader in Jersey City, New Jersey. The Senior Director, Clinical Development will fill a vital role in our growing organization serving as the Early Development Team Leader (EDTL) responsible for overseeing a globally based, multidisciplinary team responsible for successful delivery of development milestones including IND, FIH, POC, EOP2 and NDA. In addition to leading the Early Development Team (EDT), the individual will be responsible for supporting the development and writing of regulatory documents (IB/IND/CTA), study protocols and clinical development plans. The role will include oversight of design and conduct of FIH and proof of concept studies for new molecules that were discovered in Client's laboratories or obtained through in-license activities. Presently, the role will be responsible for leading one or more projects with global teams including representatives from non-clinical, clinical operations, CMC, project management and regulatory affairs in preclinical to Phase IIa (human proof of concept). Therapeutic areas may vary and the pipeline candidates may be small molecules or biologics covering broad disease markets all the way down to narrow indications including orphan conditions.
- Responsibility for the success of a project from pre-IND to EOP2
- Lead the EDT to plan, execute and manage the early stage development projects
- Set expectations of deliverables to functional representatives within the team
- Working closely with the EDT Project Manager, plan and manage the project timelines, the project budget and the human resource requirements against the approved IDP and approved resources
- Represent the project at decision-making meetings
- Additional responsibilities outside the EDT include the following; Provide scientific expertise to New Product Marketing Strategy; Working closely with Marketing and Medical Affairs, define the publication strategy; Working closely with all contributing lines of the organization, shepherd the development of an integrated development plan; Assist and manage a medical writer for full protocol, regulatory documents or other deliverables; Communicate with KOLs as needed to for development of target indications, clinical development plans, study designs and program feasibility
- Support clinical operations and regulatory affairs staff as needed; Collaborate with internal staff from multiple functions at Client, consultants and CROs; Communicate with Europe and Japan
- Reports directly to the VP/Head of Clinical Development
- Managerial: No direct supervisory duties at this time, but will coach, mentor and develop individuals and teams in a highly complex matrixed organization
- Provides project-based supervision to Medical Writer(s) and Clinical Scientist(s) as required
- Works collaboratively with functional line leadership, including Translational Medicine, Safety, Non-clinical, Data Sciences, CMC, Project Management and Regulatory Affairs
- Minimum of 15 years of industry experience (Pharmaceutical, Biotech or related field)
- Minimum of 10 years of hands-on experience developing a clinical development plan after deep understanding and evaluation of nonclinical data, CMC, regulatory, marketing and clinical operations Minimum of 5 years of hands-on experience: leading a global cross functional team for clinical development including non-clinical, clinical, data science, regulatory and CMC staff; and communicating with FDA and/or EMA Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA)
- Experience filing NDA(s); experience creating clinical development plan in women’s health, immunology, dermatology, internal medicine or neurology areas, including orphan conditions
- Proficient in designing/writing phase 1 and 2 clinical study protocols, and comfortable supporting the writing of sections from IB/IND/CTA or other regulatory dossiers as needed
- Good understanding of FDA regulatory, ICH, and GCP requirements
- Proven ability to use well-honed influencing skills in a matrix organization to help teams achieve project milestones
- Superior interpersonal skills and the ability to work across company disciplines and functional units
- Excellent communication skills, both verbal and written
- Willingness to travel up to 30-50% domestically and internationally
- An advanced degree (e.g., MD/PhD, PhD or PharmD) is required
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.