- Graduate degree required (PhD, PharmD, MD); MBA preferred
- Minimum of 12 years related experience in the pharmaceutical industry, with working knowledge of research and development and development operations.
- Experience spanning stages of pharmaceutical development process from IND- through clinic is required; BLA and launch experience is a plus.
- Previous experience developing products in the neurodegenerative space required; Alzheimer's experience strongly preferred.
- Proven proactive identification of issues and deployment of creative solutions to maintain or accelerate timelines is required.
- Ability to be a versatile and highly strategic enterprise leader.
- Highly collaborative cross-functional leader with demonstrated experience consistently driving top performance and delivering against challenging goals.
- Ability to navigate challenges with diplomacy and tact, flexibility and creativity.The Senior Director, Alzheimer's Program Lead will:
- Drive the asset strategy and lead all development and life-cycle management (LCM) projects associated with an asset from the time of Development Candidate (DC) nomination to when it completes all registration-enabling studies as a marketed product. The PL will also lead initiatives to improve timelines/cost to market (e.g. remote trials, improving asset strategy).
- Ensure that risks and challenges are addressed proactively and collaboratively with partner functions, with joint decision making when appropriate to drive, deliver and maximize asset value.
- Facilitate the Program Team in setting program vision and strategy. Defines goals, priorities and long-term plans and schedules. Aligns cross-functional, cross-divisional project goals with the company's business needs and strategies.
- Coordinate all activities involved in interactions with FDA and other regulatory authorities and key opinion leaders with respective functions.
- Proactively and regularly identifies/monitor project risks before they transform into issues and develops well thought through contingency plans; communicates timely and proactively project-related issues to senior executive management and manages issues to resolution.
- Work closely with team members to provide strategic, process, and operational leadership in the successful delivery of projects from discovery to commercialization and life-cycle management (LCM) activities.
- Link and ensure integration across cross-functional sub-teams, such as Research, TechOps, Clinical and Regulatory to execute according to the defined program plan. Align and ensure transparency of all program-related activities.
- Effectively and proactively reports on progress of projects, plans/plan changes, critical path, possible scenario and issues/risks/impact to executive management through internal or external reviews.
- Effectively leads and represents the team across multiple governance and relevant internal meetings
- Accountable for project operating budgets, monitor and control expenditures; manages variance between budgeted and actual expenditures of time, dollars, and personnel.
- Manage internal and external resources (people, information, technologies, time, and capital); allocates project resources appropriately, given division, function and individual goals and objectives to align with business imperatives.
- Proactively responds to the dynamics of a changing marketplace; directs adjustments in functional or cross-divisional plans in response to changes in strategic direction.
- Provides mentorship to the members of the teams that they oversee. Partners with functional leaders to advice and mentors team members on professional development opportunities.Compensation:
$250,000 annually
If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at or
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDSCIC
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Senior Director, Alzheimer's Program Lead - Boston, United States - Proclinical
Description
Senior Director, Alzheimer's Program Lead - Permanent - Onsite
Proclinical Staffing is seeking a Senior Director, Alzheimer's Program Lead to join a cutting-edge biotech company. This is a permanent role located in Boston, MA.
Primary Responsibilities
The Program Leader will drive strategy, leading the program team towards success by adeptly navigating the risks and challenges of drug development.
Skills & Requirements: