Senior Manager, Clinical Development
Jersey City, NJ
We are currently searching for a skilled professional to join a well-known client’s team as the Senior Manager, Clinical Development in Jersey City, NJ. This role may have global or regional responsibilities and fulfill the following roles; Clinical Program Lead (CPL); Clinical Science Lead (CSL); Clinical Scientist (CS). The Senior Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
Clinical Program Lead (CPL) Oversight
- Responsible and accountable for the development, implementation and delivery of the global clinical development strategy for a given project within time, budget and with high quality. He/she leads the development of the Clinical Development Plan in collaboration with the Clinical Science Lead and members of the Clinical Sub Team, ensuring alignment with the agreed Global Development Strategy
- Lead the execution of the agreed Clinical Development Plan
- Responsible for ensuring alignment between the Core Team, Clinical Subteam and Clinical Trial Team(s)
- Developing the proposed clinical milestones with the Clinical Subteam
- Working towards the achievement of defined project stage gates and milestones
- Overseeing all clinical development activities in collaboration with the Clinical SubTeam and Clinical Trial Team(s)
- Managing the project related clinical development budget with the Clinical SubTeam and Project Manager
- Ensuring that decisions made by the Clinical Subteam have functional backing
- Communicating project progress to their line function managers
- Communicating to the Core Team leader, Core Team and relevant functions any potential issues or risks (e.g., changes or significant risks to the Clinical Development Plan, new safety concerns) upon identification in a timely manner
- Providing Clinical Development oversight on clinical development aspects for ongoing clinical trials
- In this role, the CPL may be the Clinical SubTeam Chair, and as such a Core Team member. As the Clinical SubTeam Chair, the CPL will represent the Clinical SubTeam at the Core Team and ensures timely escalation to the Core Team (with appropriate functional representation) and the communication of information between the Core Team, Clinical Subteam, Clinical Trial Team(s), and other functional subteams, as needed
Clinical Science Lead (CSL) Oversight
- Responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to: protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions and publications associated with the clinical trials. In collaboration with the CPL and Clinical Subteam members, the CSL participates in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, the CSL is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan.
- Responsible for Acting as a key contact for the Core Team, Clinical Subteam and Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project
- Providing scientific/clinical oversight for the clinical trial in collaboration with the Clinical Subteam members
- Ensuring the review of clinical data, including protocol deviations
- Interpreting and communicating, with the CPL, clinical trial results
- Collaborating with the CPL, the Clinical Subteam and functional representatives in the development of clinical trial, regulatory and other scientific documents (e.g., Regulatory documents, presentations at congresses and publications)
- The CSL may present the clinical development aspects of a project and clinical trial results at internal or external meetings (e.g., with Regulatory Authorities, with external experts)
Clinical Scientist (CS) Oversight
- The CS is responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The CS supports the CPL and CSL in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. The CS is the key Clinical Development contact for the Clinical Trial Team
- Responsible for representing Clinical Development as a core team member on the Clinical Trial Team
- Providing a clinical review of study specific documentation and training materials
- Performing clinical data reviews
- Assessing reported protocol deviations
- Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross functionally and with Investigational sites in collaboration with the Clinical Trial Team
- The CS may present the clinical development aspects of a project and clinical trial results at internal or external meetings (e.g., with Regulatory Authorities, meetings with external experts)
- Minimum 5 years of overall work experience or equivalent combination of experience and education
- Minimum 4 years of clinical/research experience in the pharmaceutical/device industry preferred
- Scientific knowledge and experience in the relevant Therapeutic Area preferred
- Ability to travel up to at least 30% of time, including international travel
- Relevant science degree (e.g., MD, PharmD, PhD)
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.