Roles and Responsibilities
Should be a domain Expert in leading the R&D - Biosimilar project end to end.
To work with the team and key stakeholders to set the key goals and major objectives.
Expected to maintain focus and provide clear direction to both team members and with respect to external influencers, to be the champion for the project, to be clear about the programs priority in the portfolio, to demand scientific excellence from team members.
Should include the team in formulating decisions but should accept accountability for the decision. Provide an honest assessment of the project relative to current and future cost. Proactively acknowledge the time to advance the project to the next stage and when to recommend termination.
Understand the scientific rationale and technical issues associated with the project target and lead agents, with the clinical and market drivers, and with the processes and progression criteria associated with the stage of Development.
Responsible for developing a project plan that works to achieve progression criteria using sound scientific processes in the shortest amount of time with the least cost. Must challenge work that is not directly related to the critical path.
Ensure that the plan is re-evaluated, adjusted and re-negotiated at regular intervals, or when internal data or external information suggests that the timeline may slip or certain objectives may not be met.
Make sure all team members and their line managers and key stakeholders support the project.
Responsible for making clear plans on what, when and how the project goals have to be achieved.
Create and implement project plan and execution
Give clear and unbiased assessment of the movement and nature of projects in relations to production cost and expenses
Determine the appropriate time to make advancement on projects and move on to further stages. Also, acknowledge when certain strategies arent effective and implement change of plans
Carryout constant evaluation and adjustment within a specific period of time to ensure that both internal and external factors do not suffer
Manage the available resources as needed for the project ensure resource availability and also consider the negotiation of amendments to project plans to achieve best offers
Should have right presence of mind to tackle difficult situations immediately
Clarify the duties, roles and functions of team members between both prospective competing team members and their superiors
Should possess people management and motivational skills to manage any or attitude issues of any team members.
Lead the team members to perform their roles efficiently so that the project goals are achieved.
Review and give individual feedback to improve the skills of the team members so that performance of the project improves overall.
Create a sense of bonding between team members that would result in a team work rather than individual contribution which may not synchronize well with the output of other individual outputs.
Give clear directions and instructions to both team members and stakeholders with regards to external factors, to enable them carryout their duties effectively
Encourage contributions and input from team members and other key stake holders on the project and acknowledge efforts made by team members and reward them accordingly
Skills/Knowledge and experience:
Exhibit good leadership skills by carrying everyone along without bias
Be highly focused in order to stick to the objectives and goals of the company without giving in to undue distractions and challenges
Exhibit good motivational skills to bring out the best in team members
Good crises management skills to handle pressure from project challenges
/Good temperament to deal with team members shortcomings.
Candidate should have 10 to15 years of experience in drug development from early stage development to approvals in regulated markets.
An ideal candidate would be a Masters or a Ph.D in life sciences. Project management training would be an added advantage. He/she should have experience of handling a large cross functional team.
Keyskills: project target Project Lead clinical technical issues Project Management Program Manager early stage development cross functional regulated markets
Stelis BioSourceâ„¢ is the leading, fully integrated biopharmaceutical contract development and manufacturing organization (CDMO) arm of Stelis Biopharma Pvt Ltd. The powerhouse to progress your biologic products to market as efficiently as possible, we can cater for the...